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Therapeutic ultrasound for osteoarthritis of the knee or hip (Review

)
Rutjes AWS, Nüesch E, Sterchi R, Jüni P

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 1 http://www.thecochranelibrary.com

Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . . BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 Any type of therapeutic ultrasound versus control, Outcome 1 Pain. . . . . . . . Analysis 1.2. Comparison 1 Any type of therapeutic ultrasound versus control, Outcome 2 Function. . . . . . . Analysis 1.3. Comparison 1 Any type of therapeutic ultrasound versus control, Outcome 3 Number of patients experiencing any adverse event. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.4. Comparison 1 Any type of therapeutic ultrasound versus control, Outcome 4 Number of patients withdrawn or dropped out due to adverse events. . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.5. Comparison 1 Any type of therapeutic ultrasound versus control, Outcome 5 Number of patients experiencing any serious adverse event. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 2 6 6 6 8 9 11 12 13 16 17 19 21 21 21 24 36 36 37 37 38 38 38 41 41 41 42 42 42 42

Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Review]

Therapeutic ultrasound for osteoarthritis of the knee or hip
Anne WS Rutjes1 , Eveline Nüesch1 , Rebekka Sterchi1 , Peter Jüni1
1 Division

of Clinical Epidemiology and Biostatistics, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland

Contact address: Anne WS Rutjes, Division of Clinical Epidemiology and Biostatistics, Institute of Social and Preventive Medicine, University of Bern, Finkenhubelweg 11, Bern, 3012, Switzerland. arutjes@ispm.unibe.ch. a.rutjes@crc-cesi.org. Editorial group: Cochrane Musculoskeletal Group. Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 1, 2010. Review content assessed as up-to-date: 22 July 2009. Citation: Rutjes AWS, Nüesch E, Sterchi R, Jüni P. Therapeutic ultrasound for osteoarthritis of the knee or hip. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD003132. DOI: 10.1002/14651858.CD003132.pub2. Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background Osteoarthritis is the most common form of joint disease and the leading cause of pain and physical disability in the elderly. Therapeutic ultrasound is one of several physical therapy modalities suggested for the management of pain and loss of function due to osteoarthritis (OA). Objectives To compare therapeutic ultrasound with sham or no specific intervention in terms of effects on pain and function safety outcomes in patients with knee or hip OA. Search strategy We updated the search in CENTRAL, CINAHL, EMBASE, MEDLINE and PEDro up to 23 July 2009, checked conference proceedings, reference lists, and contacted authors. Selection criteria Studies were included if they were randomised or quasi-randomised controlled trials that compared therapeutic ultrasound with a sham intervention or no intervention in patients with osteoarthritis of the knee or hip. Data collection and analysis Two independent review authors extracted data using standardized forms. Investigators were contacted to obtain missing outcome information. Standardised mean differences (SMDs) were calculated for pain and function, relative risks for safety outcomes. Trials were combined using inverse-variance random-effects meta-analysis. Main results Compared to the previous version of the review, four additional trials were identified resulting in the inclusion of five small sized trials in a total of 341 patients with knee OA. No trial included patients with hip OA. Two evaluated pulsed ultrasound, two continuous and one evaluated both pulsed and continuous ultrasound as the active treatment. The methodological quality and the quality of reporting was poor and a high degree of heterogeneity among the trials was revealed for function (88%). For pain, there was an effect in favour of ultrasound therapy, which corresponded to a difference in pain scores between ultrasound and control of -1.2 cm on a 10-cm VAS (95% CI -1.9 to -0.6 cm). For function, we found a trend in favour of ultrasound, which corresponded to a difference in function scores of -1.3 units on a standardised WOMAC disability scale ranging from 0 to 10 (95% CI -3.0 to 0.3). Safety was evaluated in two trials including up to 136 patients; no adverse event, serious adverse event or withdrawals due to adverse events occurred in either trial.
Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1

Authors’ conclusions In contrast to the previous version of this review, our results suggest that therapeutic ultrasound may be beneficial for patients with osteoarthritis of the knee. Because of the low quality of the evidence, we are uncertain about the magnitude of the effects on pain relief and function, however. Therapeutic ultrasound is widely used for its potential benefits on both knee pain and function, which may be clinically relevant. Appropriately designed trials of adequate power are therefore warranted.

PLAIN LANGUAGE SUMMARY Therapeutic ultrasound for osteoarthritis This summary of a Cochrane review presents what we know from research about the effect of therapeutic ultrasound on knee or hip osteoarthritis. The previous version of this review concluded that therapeutic ultrasound had no benefit over fake therapeutic ultrasound in pain relief and functional status. The updated review shows that in people with osteoarthritis, -Therapeutic ultrasound may be beneficial for people with osteoarthritis of the knee. -Therapeutic ultrasound may improve your physical function but this finding could be the result of chance. - We are uncertain about the magnitude of effects on pain relief or the ability to use your knee, because of the low quality of the evidence. -Therapeutic ultrasound may not have any side effects: no side effects were reported, but we do not have precise information about side effects. This is particularly true for rare but serious side effects. There are no studies that address the benefits of therapeutic ultrasound in people with hip osteoarthritis. What is osteoarthritis and what is therapeutic ultrasound? Osteoarthritis is a disease of the joints, such as your knee or hip. When the joint loses cartilage, the bone grows to try and repair the damage. Instead of making things better, however, the bone grows abnormally and makes things worse. For example, the bone can become misshapen and make the joint painful and unstable. This can affect your physical function or ability to use your knee. Therapeutic ultrasound means using sound waves to try and relieve pain or disability. Your doctor or physiotherapist will use a roundheaded wand or probe on the skin of the painful area. Ultrasound gel is used on the wand and on your skin to make it more comfortable and help the sound waves reach the affected area. Best estimate of what happens to people with osteoarthritis who have had therapeutic ultrasound for a duration of 2-8 weeks: Pain -People who used therapeutic ultrasound had an improvement in their pain of about 3 on a scale from 0 (no pain) to 10 (extreme pain) after using it up to 2 months. -People who used a fake therapeutic ultrasound had an improvement in their pain of about 2 on a scale from 0 to 10 after using it up to 2 months. Another way of saying this is: - 37 people out of 100 who use therapeutic ultrasound respond to treatment (37%). - 31 people out of 100 who use fake therapeutic ultrasound respond to treatment (31%). - 6 more people respond to treatment with therapeutic ultrasound than with fake therapeutic ultrasound (difference of 6%).

Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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8 cm change on 10 -3.14) (4) ++OO low4 NNT: 6 (95% CI 5 to 12)5 Function -1.6 0. -1.320 cm VAS1 ( -1. Ltd.Therapeutic ultrasound tervention Pain VAS pain scales Follow-up: 2 to 8 weeks -1.49 (-0. -5% to 54%)7 SMD -0.9 to -0.42 to 251 0.150 per 1000 patient. Published by John Wiley & Sons.1 verse events Follow-up: 2 weeks not estimable 67 (1) ++OO low9 not estimable 67 (1) ++OO low9 0 events reported NNH not estimable .0 to 0.23) (5) cm)2 29% improvement 50% improvement ( 21%.0 cm change SMD -0. 10% to 32%)3 -2.3)6 46% improvement ( 25%.3.64 (-1.6 units on WOMAC ( -1. -3. 3 S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation] Therapeutic ultrasound compared with sham or no specific intervention for patients with knee or hip osteoarthritis Patient or population: Patients with knee osteoarthritis (none of the trials included patients with hip osteoarthritis) Settings: Private physical therapy practice in USA (1 trial) and medical university hospital outpatient clinic in Taiwan (2 trials).See comment periencing any adverse years1 event Follow-up: 2 weeks Number of patients who 17 per 1000 patient-years See comment withdrew because of ad. and outpatient clinic of department of physical medicine and rehabilitation in Turkey (2 trials) Intervention: Therapeutic ultrasound Comparison: Sham or no specific intervention Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) No of Participants (studies) Quality of the evidence (GRADE) Comments Assumed risk Corresponding risk Sham or no specific in.Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.76 to .2 cm.2 units on WOMAC Various validated function (range 0 to 10)1 scales 21% improvement Follow-up: 2 to 8 weeks ++OO low8 Little evidence for a beneficial effect [NNT: not statistically significant] 0 events reported NNH not estimable Number of patients ex.

Very low quality (+OOO): We are very uncertain about the estimate. Ltd. Nüesch 2009). 3 Percentage of improvement was calculated based on median observed pain at baseline across control groups of large osteoarthritis trials of 6. concealment of allocation methods was unclear in all trials. Low quality (++OO): Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Moderate quality (+++O): Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. concealment of allocation methods was unclear in all trials. the presence of large between trial heterogeneity and the confidence interval crossed no difference. NNT: number needed to treat. Published by John Wiley & Sons. the median control group risk across studies) is provided in footnotes. number needed to harm GRADE Working Group grades of evidence High quality (++++): Further research is very unlikely to change our confidence in the estimate of effect. possible indirectness of evidence (indirect population) in 1 trial. 8 Downgraded (2 levels) because included trials were generally of low quality and small sample size: analyses was not according to intention to treat principle in at least 2 trials. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).72 standard deviation units in the control group. 5 Absolute response risks for pain in the control groups were assumed 31% (see methods section).g.6 units (Nüesch 2009). NNH. . and the possible indirectness of evidence (indirect population) in 1 trial. 6 Standardised mean differences (SMDs) were back-transformed onto a standardised WOMAC disability score ranging from 0 to 10 on the basis of a typical pooled SD of 2. 7 Percentage of improvement was calculated based on median observed WOMAC function scores at baseline across control groups of large osteoarthritis trials of 5.1 cm on 10 cm VAS (Nüesch 2009). 4 Downgraded (2 levels) because included trials were generally of low quality and small sample size: analyses was not according to intention to treat principle in at least 3 trials.1 in trials that assessed function using WOMAC disability scores and expressed as change based on an assumed standardised reduction of 0. 1 Median reduction as observed across placebo groups in large osteoarthritis trials (see methods section. GRADE: GRADE Working Group grades of evidence (see explanations). CI: Confidence interval. inadequate patient blinding in 3 trials. SMD: standardised mean difference.Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. 4 Number of patients ex.58 standard deviation units in the control group.5 cm in large trials that assessed pain using a VAS and expressed as change based on an assumed standardised reduction of 0. 2 Standardised mean differences (SMDs) were back-transformed onto a 10 cm visual analogue scale (VAS) on the basis of a typical pooled SD of 2.4 per 1000 patient-years See comment periencing any serious 1 adverse event Follow-up: 2 and 15 weeks not estimable 136 (2) ++OO low10 0 events reported NNH not estimable *The basis for the assumed risk (e.

possibly leading to selective outcome reporting bias. no relative risk could be calculated. 5 9 Downgraded (2 levels) because of: small sample size. due to absence of events. 10 Downgraded (2 levels) because of: small sample size. 1 out of 5 studies reported this outcome. Ltd. possibly leading to selective outcome reporting bias. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx .Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. 2 out of 5 studies reported this outcome. no relative risk could be calculated. Published by John Wiley & Sons. due to absence of events.

Composite pain scores other than WOMAC 5. 6 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. OA is characterized by focal areas of loss of articular cartilage in synovial joints. Main outcomes were pain and function. Therapeutic ultrasound is one of many physical therapy modalities and can be used as part of an overall rehabilitation program (Rand 2007). If data on more than one pain scale were provided for a trial. Other algofunctional scale 10. including physical therapy (Zhang 2008). Pulsed ultrasound produces non-thermal effects and is generally recommended for acute pain and inflammation. Types of outcome measures Main outcomes OBJECTIVES We set out to compare therapeutic ultrasound with sham or no specific intervention in terms of effects on pain and function and safety outcomes in patients with knee or hip OA and to explore whether potential variation between trials could be explained by characteristics of the ultrasound. Composite disability scores other than WOMAC 5. but does not specifically mention ultrasound as treatment adjunct. Disability other than walking 6. . Patient’s global assessment 11. The objectives of management of knee and hip OA are to relieve pain and to maintain or improve function. causal associations and outcomes vary markedly according to the joint site affected (Jüni 2006). accompanied by subchondral bone changes. Types of participants At least 75% of patients with clinically and/or radiologically confirmed osteoarthritis of the knee or hip. Its prevalence. osteophyte formation at the joint margins. experimental and control groups. Concurrent therapy was accepted providing it was provided to both. Lequesne osteoarthritis index global score 8. Ltd. Global pain 2. we referred to a previously described hierarchy of pain-related outcomes (Jüni 2006. WOMAC disability subscore 4. WOMAC global scale 7. Phonophoresis (the use of ultrasound to enhance the delivery of topically applied drugs) or extracorporeal ultrasonic treatment (derivative of lithotripsy. Physician’s global assessment If data on more than one function scale were provided for a trial. Global disability score 2. but the recommendation was not based on evidence from randomised trials. Other algofunctional scale 9. WOMAC global algofunctional score 8. as currently recommended for osteoarthritis trials (Altman 1996. Walking disability 3. Nelson 1999) that can be pulsed or continuous. Therapeutic ultrasound that penetrates deeply enough to increase collagen elasticity may be useful in the early stages of a flexibility program (Hicks 1990). Therapeutic ultrasound consists of high frequency vibrations (Hartley 1993. Types of interventions Any type of continuous or pulsed therapeutic ultrasound. Lequesne osteoarthritis index global score 9. Rest pain or pain during the night 7.BACKGROUND Osteoarthritis (OA) is an age related condition. Only 1 out of 5 existing guidelines considering ultrasound actually recommended its use. Pham 2004). Published by John Wiley & Sons. Patient’s global assessment 10. 1. Reichenbach 2007) and extracted only data on the pain scale that was highest on this hierarchy: 1. Pain on activities other than walking 6. The 2008 OARSI recommendations for the management of hip and knee OA state that the optimal management of OA requires a combination of non-pharmacological and pharmacological modalities. WOMAC osteoarthritis index pain subscore 4. Eligible control interventions were placebo or a non-intervention control (usual care). the mechanical breaking up of renal stones with sound waves) were not considered. Physician’s global assessment If pain or function outcomes were reported at several time-points. Continuous ultrasound generates thermal effects (Rand 2007). we extracted data according to hierarchy presented below. thickening of the joint capsule and mild synovitis (Solomon 1997). Pain on walking 3. METHODS Criteria for considering studies for this review Types of studies Randomised or quasi randomised controlled trials with a control group receiving a sham intervention or no intervention. by biases affecting individual trials or by publication bias. occurring more frequently in women than in men. we extracted the estimate at the end of the treatment period.

defined as the extent of confidence into the estimated treatment benefits and harms. If effect sizes could not be calculated. opaque envelopes. Data collection and analysis Selection of studies Two review authors independently evaluated all titles and abstracts for eligibility. persistent or significant disability.com). patient characteristics (gender. 2009 using a combination of keywords and text words related to ultrasound combined with keywords and text words related to osteoarthritis and a validated filter for controlled clinical trials (Dickersin 1994). We applied no language restrictions. Assessment of risk of bias in included studies Two review authors (AR and EN or RS) independently assessed randomisation. including type of device. mechanisms considered adequate included random-number tables. 2009. contacted content experts and trialists and screened reference lists of all obtained articles. type and source of financial support and publication status. we extracted data from the first period only. blinding and adequacy of analyses (Jüni 2001). Handling of incomplete outcome data was considered adequate if all randomised patients were included in the analysis (intentionto-treat principle).interscience. www. Data extraction and management Two review authors (AR and EN or RS) extracted trial information independently using a standardised. For crossover trials. Disagreements were resolved by consensus. and drawing of lots. average age. . patients who were withdrawn or dropped out because of adverse events.org. congenital abnormality/birth defect of offspring. The search strategy is presented in Appendix 1 and Appendix 2. If some of the required data were unavailable. www. Search methods for identification of studies Electronic searches We searched electronic databases of CENTRAL through The Cochrane Library (http://mrw. we considered all. used Science Citation Index to retrieve reports citing relevant articles. Ltd. MEDLINE and EMBASE through the Ovid platform (www. Disagreements were resolved Data synthesis Continuous outcomes were summarized using standardized mean differences (SMD). such as alternation or the allocation of patients according to date of birth.gov. www.au. The last update of the manual search was on February 02. Huang 7 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.clinicaltrials. the frequency and duration of treatment and the total number of sessions. If multiple reports described the same trial.umin. and patients experiencing any serious adverse events between randomisation and end of follow-up. trial size. were considered quasi-randomised. prolongation of hospitalisation. function. shuffling of cards. Serious adverse events were defined as events resulting in hospitalisation. characteristics of pain. duration of symptoms. with the differences in mean values at the end of treatment across treatment groups divided by the pooled standard deviation. computer-generated random numbers. any specific skin or probe preparation. means and measures of dispersion were approximated from figures in the reports. If differences in mean values at the end of the treatment were unavailable. we used GRADE to describe the quality of the overall body of evidence (Guyatt 2008. type of joint). Generation of sequences was considered adequate if it resulted in an unpredictable allocation schedule.Secondary outcomes Secondary outcomes were the number of patients experiencing any adverse event. we searched several clinical trial registries (www. Two components of randomisation were assessed: generation of allocation sequences and concealment of allocation. differences in mean changes were used. trials using potentially predictable allocation mechanisms. coin tossing. trial duration (defined as time from randomisation until end of follow-up). CINAHL through EBSCOhost. Published by John Wiley & Sons. Higgins 2008). head size of the probe. if the investigators responsible for patient selection were unable to suspect before allocation which treatment was next. Blinding of patients was considered adequate if a sham intervention was used that was identical in appearance to the experimental intervention. http://www. minimisation. including related reviews. We extracted the characteristics of the therapeutic application.pedro. and safety outcomes. sealed. methods considered adequate included central randomisation and sequentially numbered. we used approximations as previously described (Reichenbach 2007).au/). lifethreatening events or death.org.controlledtrials. Allocation concealment was considered adequate.ovid. Whenever possible. Physiotherapy Evidence Database (PEDro. Finally. Searching other resources We manually searched conference proceedings.com/cochrane/ ). all from implementation to July 23.jp/ctr) to identify ongoing trials. we contacted the authors for additional data. we used results from an intention-to-treat analysis. When necessary.actr. Other data extracted included the type of control intervention used.ac. piloted data extraction form accompanied by a codebook. design. Disagreements were resolved by discussion. Finally.wiley. by discussion.com. Trials using an unpredictable allocation sequence were considered randomised.

Median risks of 150 patients with adverse events per 1000 patient-years.80 a large difference (Cohen. Jüni 2006). With a median standardised pain intensity at baseline of 2. Analyses were performed in RevMan version 5 (Nordic Cochrane Centre. this percentage was used as the control group response rate to calculate NNTs for treatment response on function. Then. The association between trial size and treatment effects was investigated in funnel plots. use of concurrent treatment. which corresponds to an average decrease of 1. 8 . Again.25 and 2. Two trials evaluated pulsed ultrasound (Falconer 1992. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Özgönenel 2009) and one evaluated both pulsed and continuous ultrasound as the active treatment (Huang 2005 B). difference in the use of analgesic co-interventions. and -0. 1988. although the interpretation of I2 depends on the size and number of trials included (Rücker 2008). 4 patients with serious adverse events per 1000 patient-years and 17 dropouts due to adverse events per 1000 patient-years observed in placebo groups in large osteoarthritis trials (Nüesch 2009) were used to calculate NNHs for safety outcomes. and numbers needed to harm (NNH) to cause one additional adverse outcome. duration of treatment period and source of funding. This percentage was used as the control group response rate to calculate NNTs for treatment response on pain. duration of stimulation per session.50 in approximately 67%. 1988. Binary outcomes were expressed as relative risks. plotting effect sizes on the horizontal axis against their standard errors on the vertical axis. On the basis of a median pooled SD of 2.1 (StataCorp. Published by John Wiley & Sons. Characteristics of excluded studies.80 correspond to approximate differences in pain scores between experimental and control groups of 0. Copenhagen) and STATA version 10. 1.80 in about 53% of cases (Cohen. An SMD of -0. specific type of ultrasound therapy (pulsed versus continuous). use of a sham intervention in the control group. we calculated that a median of 31% of patients in the control group would achieve an improvement of pain scores of 50% or more. blinding of outcome assessors. An SMD of -0. SMDs can also be interpreted in terms of the percent of overlap of the experimental group’s scores with scores of the control group. moderate. We used standard inverse-variance random-effects meta-analysis ( DerSimonian 1986) to combine trials.2005 B had two experimental groups. Huang 2005 A). and an SMD of -0. Based on the median standardised WOMAC function score at baseline of 2.5. 26% of patients in the control group would achieve a reduction in function of 50% or more. 50% and 75% may be interpreted as low.05. we converted SMDs of pain intensity and function to odds ratios (Chinn 2000) to derive numbers needed to treat (NNT) to cause one additional treatment response on pain or function as compared with control.50 and -0. which describes the percentage of variation across trials that is attributable to heterogeneity rather than to chance and the corresponding χ 2 test. For the main analysis on pain and function. We therefore inflated the standard error with the square root of the ratio of number of knees divided by number of patients to account for the correlation of knees within patients. Five randomised trials in 341 patients met our inclusion criteria. and high between-trial heterogeneity.20 indicates an overlap in the distributions of pain or function scores in about 85% of cases. Jüni 2006). All P values are twosided. analysis in accordance with the intention-to-treat principle. -0. we performed analyses stratified by the following trial characteristics: concealment of allocation. We defined treatment response as a 50% improvement in scores (Clegg 2006). SMDs of -0.0 cm on a 10 cm VAS. Texas). In Huang 2005 A and Huang 2005 B the units of randomisation were patients. a sample size of 100 patients per group will yield more than 80% power to detect a small to moderate SMD of -0.72 standard deviation units observed in large osteoarthritis trials (Nüesch 2009). trial size.20 standard deviation units can be considered a small difference between experimental and control group. blinding of patients.50 a moderate. Characteristics of studies awaiting classification. an SMD of -0. A cut-off of 200 patients was used to distinguish between small and large trials. We identified 2156 references to articles and considered 66 to be potentially eligible (Figure 1). SMDs for function were back transformed to a standardised WOMAC disability score (Bellamy 1995) ranging from 0 to 10 on the basis of a median pooled SD of 2. I2 values of 25%. RESULTS Description of studies See: Characteristics of included studies. We assessed asymmetry by the Egger’s test (Sterne 2001).58 standard deviation units (Nüesch 2009).7 standard deviation units and the median standardised decrease in function scores of 0. an SMD of -0.4 standard deviation units and a median standardised decrease in pain scores of 0.5 cm found in large-scale osteoarthritis trials that assessed pain using a 10 cm visual analogue scale (VAS) (Nüesch 2009).2 standard deviation units (Nüesch 2009). College Station. which were combined using weighted averages of the point estimates and pooled standard deviations. total number of sessions.1 units observed in large-scale osteoarthritis trials (Nüesch 2009).40 at a two-sided P value of 0. whereas the units of analysis were knees. We quantified heterogeneity between trials using the I2 statistic (Higgins 2003). Ltd. Cochrane Collaboration. two continuous ( Cetin 2008.20.

Figure 1. three and three. Huang 2005 B. it was unclear if concurrent treatment was given. manual therapy and joint protection. From these data. instruction in daily home exercises were given in the trials by Falconer 1992. Falconer 1992 isometric exercise. Huang 2005 A and Huang 2005 B isokinetic exercise and hot packs.5 W/cm2 was the maximum intensity in trials using continuous ultrasound. Özgönenel 2009).5 W/cm2 . The two trials by Huang and colleagues reported that intensity was increased up to a level at which a warm sensation or a mild sting was felt. 1 to 1. Huang 2005 A. Therefore. but referring to their intervention as physiotherapy program. Özgönenel 2009). The median number of treatment sessions per week was 3 (range 2 to 5). respectively in Falconer 1992. 2. The duration of treatment per lesion was reported to be 3. which was 1.5 W/cm2 in trials using pulsed ultrasound. Published by John Wiley & Sons. Only two trials reported the size of the probe used (Falconer 1992. not exceeding 2. Huang 2005 A and Huang 2005 B. in which three used a sham intervention in the control group (Falconer 1992. respectively.7 W/cm2 in Falconer 1992. Cetin 2008 used hot packs and isokinetic exercise. Cetin 2008 and Özgönenel 2009 described that the duration of ultrasound per session was 10 and 5 minutes. All trials used ultrasound probes with direct skin contact at 1 MHz. and Huang 2005 B. Flow chart All trials used a parallel group design. All but one trial (Özgönenel 2009) provided standardised concurrent treatment in both experimental and control groups. 5 and 5 minutes. In addition. mobilising exercise. 15 and 15 minutes in these trials. 9 . we could not exclude that other physiotherapy modalities were provided in addition to ultrasound treatment. we estimated that the duration of ultrasound treatment per session was 12. Treatment parameters were insufficiently described (see Characteristics of included studies). the median length of the treatment period Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Two trials explicitly stated the mean intensity. the number of lesions treated per session four. with the authors stating that “no physiotherapy was prescribed prior to ultrasound treatment to either of the groups”. Ltd. In the trial by Özgönenel 2009.5 W/cm2 in Cetin 2008 and 1.

Ltd. In another trial. Kalpakcioglu 2006 and Svarcova 1988. Huang 2005 A. sealed and opaque envelopes. and all patients in this study had chronic knee contractures (Falconer 1992). exercise and hot packs versus exercise in Ones 2006. random allocation could have been undermined. In two trials (Cetin 2008. The source of funding was unclear in the the other two trials (see Characteristics of included studies). Three trials used sham interventions. two reported the average body mass index. The Characteristics of excluded studies table presents the main reasons for exclusion of other studies. Three trials were supported by a non-profit organisation (Falconer 1992. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Risk of bias in included studies Figure 2 summarises the methodological characteristics and source of funding of included trials. Two trials were described as double-blind (Falconer 1992. dials were lit. All trials explicitly included patients with knee OA only. 21 out of 40 patients had severity grade III or IV according to Kellgren and Lawrence. which was not given in the control group: ultrasound therapy. 8 out of 69 patients had received total knee arthroplasty more than 6 months before the trial started. transcutaneous electrostimulation and exercise versus exercise in Dincer 2008 and glucosamine sulfate. Three trials explicitly specified primary outcomes. Özgönenel 2009). In one trial. None of the trials was considered to have performed an intentionto-treat analysis for any of the primary outcomes of this review. ultrasound therapy. Huang 2005 B. None of the trials had a sample size of approximately 200 patients to achieve sufficient power for detecting a small to moderate SMD. Özgönenel 2009) it was unclear whether exclusions from the analysis had occurred. Published by John Wiley & Sons. The envelopes should have been numbered 1 to 140 and 1 to 120 to cover the numbers of patient randomised in Huang 2005 A and Huang 2005 B. respectively. using identical devices in experimental and control groups (Falconer 1992. with the diagnosis based on clinical and/or radiographic evidence. Özgönenel 2009 stated that the probe was disconnected on the back of a working ultrasound machine and the patient was unable to determine whether the cable was disconnected or not. the sham device was fully functional. Exclusions had explicitly occurred in all but two trials. ultrasound therapy versus phonophoresis in Dafinova 1996 and Kozanoglu 2003. Özgönenel 2009). Huang 2005 B). Bansil 1975 and Svarcova 1988 were included in the previous version of this review. Only the sham device used in Falconer 1992 and Özgönenel 2009 2009 were therefore considered to have adequate patient blinding. Only Falconer 1992 and Özgönenel 2009 reported a sample size calculation. ultrasound therapy with deep relief gel versus ultrasound therapy with standard gel in Yang 2005. Özgönenel 2009). One trial reported the average disease duration. audible beeps were given. one was also supported by a commercial body (Huang 2005 B). which was 28 and 32 kg/m2 in Cetin 2008 and Özgönenel 2009. Both trials by Huang et al reported the use of sequentially numbered. which was 7 years (Falconer 1992). NSAID. pulsed short wave diathermy. and ultrasound therapy versus shortwave diathermy or galvanic electrostimulation in Bansil 1975. exercise and ultrasound therapy versus pulsed short wave diathermy with different parameters. but no energy was delivered to the tissue. Huang 2005 B. the investigators stated that the absence of a warm or stinging sensation in the control group resulted in a failure of patient blinding. In Huang 2005 B.was 8 weeks (range 2 to 8). with percentages of exclusions ranging from 0% to 10% in experimental groups and from 0% to 17% in control groups. Three randomised trials were excluded because ultrasound was compared to active control interventions: ultrasound therapy versus short wave diathermy or ultrasound therapy with exercise or diathermy with exercise in Jan 1991. however (Cetin 2008). although it was unclear whether these were specified a priori (Falconer 1992. 10 . In Falconer 1992. Five randomised trials were excluded because a concurrent therapy was given in the ultrasound group. As we had no evidence to suggest that the envelopes were appropriately numbered in a sequential manner. ultrasound therapy and traditional Chinese medicine in Qin 2008. but they reported that envelopes were sequentially numbered I to IV. exercise and ultrasound therapy in Tuzun 2003. The majority of patients had a clinical severity requiring simple non-surgical treatments (Jüni 2006). No trial reported adequate sequence generation or adequate concealment of allocation. likely to represent the four comparison groups patients were allocated to in both of these trials. respectively. NSAID and ultrasound therapy versus combined traditional Chinese medicine versus glucosamine sulfate. treatment according to Dutch physiotherapy guideline versus behavioral graded activity in Veenhof 2007.

Ltd. Published by John Wiley & Sons. (+) indicates low risk of bias. 11 . (?) unclear and (-) a high risk of bias on a specific item. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.Figure 2. Methodological characteristics and source of funding of included trials.

P value for asymmetry = 0. 464 knees) contributed to the meta-analysis of pain outcomes (Figure 3). Forest plot of 5 trials comparing the effects of therapeutic ultrasound and control (sham or no intervention) on knee pain.2 cm on a 10-cm VAS between ultrasound and control. the potential for selective reporting of function outcomes and the possible indirectness of one trial (Summary of findings for the main comparison). which corresponds to a difference in pain scores of 1. Effects of interventions See: Summary of findings for the main comparison Pain Five trials (320 patients. Ltd. this corresponds to a difference of 21% improvement (95% CI 10% to 32%) between electrostimulation and control (Summary of findings for the main comparison). the quality of the evidence (Guyatt 2008) was classified as low in view of the risk of bias in the included.1 cm in placebo groups at baseline. For the safety outcomes. The analysis suggested a SMD of -0. The funnel plot did not appear asymmetrical ( Figure 4. The NNT to cause one additional treatment response on pain as compared to control was 6 (95% CI 5 to 12).76 to -0.23). the quality of the evidence (Guyatt 2008) was classified as low.23). again because of the predominantly small trials of questionable quality. the large heterogeneity between trials on function. Published by John Wiley & Sons. Data relating to the 2 experimental arms in Huang 2005 B were pooled.For the effectiveness outcomes pain and function. Referring to a median pain intensity of 6. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.25). predominantly small trials of questionable quality. 12 . Figure 3. Values on x-axis denote standardised mean differences.49 (95% CI -0. the small number of trials reporting the outcomes and the absence of events resulting in not estimable relative risks. An I2 of 26% indicated a low degree of of between-trial heterogeneity (P value for heterogeneity = 0.

we could not evaluate the impact of these characteristics. of trials No. performed analyses according to the intention-to-treat principle or achieved a sample size of at least 200 patients. Table 1. The absence of sufficient (high quality) trials hampered the exploration of associations of SMDs with other trial characteristics. SMDs did not seem to depend on type of control intervention. In all trials it was unclear whether the provision of analgesic cointerventions was similar between groups. Table 1 presents results from stratified analyses. Published by John Wiley & Sons. of patients: No. none had used adequate concealment of allocation. of patients: experimental control n n Pain-intensity Heterogeneity P for interaction n SMD (95% CI) I2 (%) 13 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. total number of sessions or treatment duration. . patient blinding. There was no evidence to suggest that SMDs depended on the type of ultrasound therapy used (P value for interaction = 0. Ltd.15). Funnel plot for effects on knee pain. on y-axis to standard errors of SMDs. Numbers on x-axis refer to standardised mean differences (SMDs). There was little evidence that estimates of SMD increased with the duration of ultrasound therapy applied per session (P value for trend = 0.Figure 4. Therefore. Results of stratified analyses of pain outcomes Variable No.48).

87 to N/A 0.26% 0.02) -0.3 tion No control inter.0% 0.11) 0. Results of stratified analyses of pain outcomes (Continued) All trials 5 177 143 -0.8 Type of control intervention Sham interven.04 (-0.08) -0.42 (-0.44) 52 50 0.0% 0.52 (-0.80 to .52 (-1. Ltd.0% 0.01 to . Published by John Wiley & Sons.01 to .Table 1.76 to .26) 0.04) 0. 14 .52 (-1.15‡ 10 minutes 1 20 20 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.04) 125 93 -0.60% 0.40 (-1.60% 0.62 (-0.80 to 45% 0.23) 0.58 to N/A 0.49 (-0.48 Pulsed 3 96 78 Duration of US per session 5 minutes 1 34 33 -0.0% 0.2 vention Blinding of patients Adequate 2 68 68 -0.71 Inadequate unclear or 3 109 75 Type of Ultrasound† Continuous 3 81 65 -0.39 (-0.76 to .76 to .24) -0.71 Inadequate unclear or 3 109 75 Blinding of outcome assessor Adequate 2 68 68 -0.08) -0.97 to .24 to 77% 0.38 (-0.42 (-0.66) 0.

N/A 0.04) 12 1 34 35 24 3 109 75 Duration of treatment period 2 weeks 1 34 33 -0.38 (-0.11) 0.03) -0.72 (-1.31% 0.69‡ 15 minutes 2 89 55 Total number of sessions 10 1 34 33 -0. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.45 No or unclear 4 120 118 US: Ultrasound therapy. †Huang 2005 B contributed to both strata.52 (-1.60% 0.52 (-1.11) -0. ‡.43 (-0.04) 0.93 to N/A 0.74 to .87 to N/A 0.69‡ 6 weeks 1 34 35 8 weeks 3 109 75 Commercial funding Yes 1 57 25 -0.01 to .: number.01 to .38 (-0. 15 . No.45 (-0.11) -0. N/A: not applicable.41) 0. with the same 25 control patients displayed in each stratum.03) -0. Ltd.45 (-0.93 to N/A 0.93 to N/A 0.60% 0.23) -0.20 to .87 to N/A 0.Table 1.03) -0.77 (-1.11 to . Published by John Wiley & Sons. P-value from test for trend.0% 0. Results of stratified analyses of pain outcomes (Continued) 12 minutes 1 34 35 -0.45 (-0.

this corresponds to a difference of 25% improvement (95% CI -5% to 54%) between electrostimulation and control (Summary of findings for the main comparison). favouring ultrasound therapy. An I2 of 88% indicated a large degree of betweentrial heterogeneity (P value for heterogeneity < 0. Data relating to the 2 experimental arms in Huang 2005 B were pooled.3 units on a standardised WOMAC disability scale ranging from 0 to 10. 16 .14. On visual inspection. Published by John Wiley & Sons.42 to 0. Referring to a median function score of 5. The funnel plot did not appear asymmetrical (Figure 6. The NNT to cause one additional treatment response on function as compared to control was not calculated as differences were not statistically significant.Function Four trials (251 patients) contributed to the meta-analyses of function (Figure 5). in contrast to the other trials.001). the variation could be explained by the trial of Cetin 2008 that estimated an effect size favouring control. The trial by Huang 2005 A reported an unrealistically large effect in favour of ultrasound therapy. P value = 0.6 units in placebo groups at baseline. Forest plot of 3 trials comparing the effects of therapeutic ultrasound and control (sham or no intervention) on function.93). P value for asymmetry = 0. Values on x-axis denote standardised mean differences. The analysis suggested a SMD of -0. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Figure 5. corresponding to a difference in function scores of 1.11). Ltd.64 (95% CI -1.

005). Published by John Wiley & Sons. of trials No. of patients: No. Ltd.14) I2 (%) (-1.Figure 6. of patients: experimental control n 143 n 108 Pain-intensity Heterogeneity P for interaction n All trials 4 SMD (95% CI) -0. with more favourable effects of pulsed ultrasound therapy (P value for interaction = 0.42 88% Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Confidence intervals were either wide and tests of interaction not significant or the impact of several characteristics could not be evaluated at all. Numbers on x-axis refer to standardised mean differences (SMDs). Table 2. but a positive interaction test suggested that SMDs were associated with the type of ultrasound therapy used.16). Results of stratified analyses of function Variable No.The absence of sufficient high quality trials hampered the exploration of potential effects of all other treatment and design characteristics. 17 . on y-axis to standard errors of SMDs. Table 2 presents results from stratified analyses. Funnel plot for effects on functioning of the knee. There was little evidence that estimates of SMD increased with the duration of ultrasound therapy applied per session (P value for trend = 0.64 to0.

76 (-1.16) 0.66 to 95% 1.27 (-0. Results of stratified analyses of function (Continued) Type of control intervention Sham interven.27 (-0.76% 0.22) -0.16‡ 10 minutes 1 20 20 12 minutes 15 minutes 0 2 89 55 -1.005 Pulsed 2 62 43 Duration of US per session 5 minutes 1 34 33 -0.58 (-2.30 (-1.70 Inadequate unclear or 3 109 75 Blinding of outcome assessor Adequate 2 66 63 -0.15 (-0.93 52 50 0.76 to N/A 0.95) 0.30 to N/A 0.0% 1.42) -0. Published by John Wiley & Sons.29) 0.2 vention Blinding of patients Adequate 1 34 33 -0.52 Inadequate unclear or 2 77 45 Type of Ultrasound† Continuous 3 81 65 -0.90) 0.50 to 89% 0.31) 91 58 -0.00 to .58 (-1.28 (-2.33 (-0.51) 18 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.56 to 41% 0.Table 2.2 tion No control inter.68 (-2. .26) -1. Ltd.97 (-2.22) 0.83 to 94% 0.76 to N/A 0.03) -0.05 to .20 to 69% 0.35 to 93% 0.

76 (-1.78 Commercial funding Yes 1 57 25 -0. Ltd.27 (-0.: number.39 to . ‡ P-value from test for trend. .22) 6 weeks 8 weeks 0 3 109 75 -0.76 to N/A 0. N/A: not applicable. Two trials (136 patients) contributed to the meta-analysis of patients experiencing any serious adverse event (Falconer 1992. neither in the experimental nor in the control group.90 (-1.76 (-1. No. This trial reported that no adverse events or withdrawals or dropouts due to adverse events had occurred. Safety One trial contributed to the analysis of patients experiencing any adverse event or being withdrawn or dropping out because of adverse events (Özgönenel 2009).41) -0.76 to N/A 0.70 12 24 0 3 109 75 -0. In general. Results of stratified analyses of function (Continued) Total number of sessions 10 1 34 33 -0. with the same 25 control patients displayed in each stratum.83 to 94% 0.70 Duration of treatment period 2 weeks 1 34 33 -0.Table 2.56) No or unclear 3 86 83 US: Ultrasound therapy. DISCUSSION Summary of main results Our systematic review of trials comparing any type of therapeutic ultrasound with a sham or non-intervention control revealed a lack of adequately sized.22) 0. Özgönenel 2009). there was no evidence to suggest that electrostimulation is unsafe.N/A 0. methodologically sound and appropriately 19 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. the relative risk could not be calculated since both reports stated that no serious adverse events had occurred. relative risks could not be estimated.31) 0.65 to 91% 0.27 (-0.31) 0. neither in the ultrasound nor in the control group. Again.54 (-1.83 to 91% 0. Therefore. †Huang 2005 B contributed to both strata. Published by John Wiley & Sons.

which included three studies. or reported whether primary outcomes were specified a priori. we used random effects models. None of the trials was analysed according to the intention-to-treat principle. The confidence intervals of this trial’s effect size for pain overlapped with the confidence intervals of all other trials. Svarcova 1988). Tendal 2009). followed by an exploration of sources of variation between trials. transcription errors and other sources of observer variation (Egger 2001. differences in patient characteristics. favouring therapeutic ultrasound. As with any systematic review. were done independently by two authors to minimize bias. Here we will focus mainly on the similarities with and differences to the previous version of this review (Welch 2001). Only two trials reported safety outcomes.3 to 1. which resulted in four additional trials. We updated the search and used stricter selection criteria. These discrepancies may be due to differences in characteristics of the intervention. Cetin 2008 reported a null effect for pain and a trend towards a harmful effect of ultrasound for function. including 82 patients at most. Walking speed was also recorded in Falconer 1992. we only included randomised trials. One trial showed an unrealistically large SMD for function (Huang 2005 A). however. Our overall estimates for pain and function seemed moderate. blinding. 95% CI -2. Here we focused on sham or non-intervention controls and excluded two previously included studies (Bansil 1975. The absence of significance can not be explained by sample size alone. which showed a clearcut Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Ltd. Here. and Huang 2005 B. In this update. Agreements and disagreements with other studies or reviews We are aware of 14 related reviews addressing the effectiveness of ultrasound therapy for knee or hip osteoarthritis (list available on request). which makes an exploration of sources of variation including different types of bias mandatory. they were clearly incompatible with Huang 2005 A. As indicated above. In contrast to the review of Welch 2001. suboptimal design choices and type of funding. therapeutic appli20 Potential biases in the review process Our review is based on a broad literature search. and characteristics of ultrasound therapy. The discrepancies are unlikely to be explained by the type of scale used. there is no evidence to suggest that ultrasound therapy is unsafe. accordingly the estimated heterogeneity between trials was low.1 in Huang 2005 A and -2. our study is limited by the quality of included trials. None of the trials described generation of allocation sequences or concealment of allocation. generally. To analyse continuous data.reported trials and a high degree of between trial heterogeneity for one of the two main outcomes. Trial selection and data extraction. ultrasound therapy is rather unlikely to cause serious adverse events but active surveillance of harms with formal monitoring of potential adverse events is clearly desirable. . benefit of ultrasound. Wood 2008. Model selection based on the mechanistic application of heterogeneity tests should be avoided. Conversely. inadequate reporting and small sample size. In addition. and although we were unable to obtain sufficient data to calculate the SMD for function. and it seems unlikely that we missed relevant trials (Egger 2003). due to the low number of trials identified. which was not possible in the previous version. including quality assessment. If we had used walking speed data rather than the Lequesne index as a measure of function. The low number of trials hampered our exploration of the potential effects of ultrasound modalities. fixed effect models were used in the previous version unless there was statistically significant heterogeneity between trials based on χ 2 testing. the stage of OA. intentionto-treat analysis. but we share concerns expressed by Welch 2001. as the number of patients in Falconer 1992 exceeded the numbers analysed in Huang 2005 A. SMDs for function were discrepant.1. however: the Lequesne algofunctional scale used by Cetin 2008 was also used in Huang 2005 A and Huang 2005 B. however: whereas the effect size in Özgönenel 2009 were just about compatible with Cetin 2008. 95% CI -2. effect sizes in the trials by Huang and colleagues would have been even more extreme in favour of ultrasound (SMD -1. Welch and colleagues also included other design types and allowed active treatment in the control group. trials generally suffered from poor methodological quality. including concealment of allocation. In view of its mechanisms of action. non-significant and in contrast to Huang and colleagues’ results. Overall effect sizes for pain relief and improvement of function in patients with knee osteoarthritis seemed moderately in favour of ultrasound therapy. and only one trial described the occurrence of adverse events or withdrawals and dropouts because of adverse events. the population. bias or chance.7. Welch and colleagues used weighted mean differences of the change from baseline scores. Quality of the evidence The methodological quality and the quality of reporting was poor. we performed a detailed quality assessment of component trials. which made the interpretation of results difficult. All trials were small sized. Components used for quality assessment are validated and reported to be associated with bias (Jüni 2001. Published by John Wiley & Sons. which will generally be more conservative in terms of the estimated precision. Nüesch 2009).64 to -1. whereas we used SMDs of end of treatment scores. who stated that conclusions were limited by the poor reporting of the characteristics of the device. the reported results indicate that differences between groups were likely to be small. Welch 2001 concluded that ultrasound therapy appeared to have no benefit over placebo or short wave diathermy for people with hip or knee OA.50 in Huang 2005 B). but will be more affected by small study effects than a fixed effect model. Results from the previous and current version are therefore not directly comparable.

however. et al. for both trials of Huang 2005 A and Huang 2005 B our ratings concerning generation of allocation sequences and concealment of allocation differ. Beverley Shea.86:1545–51. we think ultrasound should not be discarded as treatment adjunctive. The trials should enrol patients without prior experience of ultrasound therapy or evaluate success of blinding at the end of trial. are potentially clinically relevant and deserve further clinical evaluation. Arthritis and rheumatism 2005. Comparing hot pack. however. Aytekin E. Özgönenel 2009 {published data only} Özgönenel L.org. Yang RC. Ltd. Evaluation whether effects increase with longer stimulation times per session or with type of ultrasound is recommended. Our ratings of methodological quality differ in some respect from those that can be found in PEDro (http://www. 21 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. however. As an example. Hayes KW.35(1):44–9. This difference can not be explained by the definitions used. As in the present review. AUTHORS’ CONCLUSIONS REFERENCES References to studies included in this review Cetin 2008 {published data only} Cetin N. Huang MH. Ultrasound in medicine & biology 2009.pedro. We rated these components as unclear. hampered by the inclusion of only small trials of questionable quality. A double-blind trial of clinical effects of therapeutic ultrasound in knee osteoarthritis. Following this statements. Huang 2005 B {published data only} Huang MH. Lin YS. The effects of ultrasound therapy on both. PEDro does not allow for a category unclear. A sample size of 2 x 100 patients will yield more than 80% power to detect a small to moderate SMD of -0.40 at a two-sided P value of 0. The authors are grateful to Judith Falconer for providing additional information concerning design and for trying to locate files of her trial published in 1992. Implications for practice Despite the widespread use of therapeutic ultrasound in physical therapy. Aytar A. They highlighted. Yang RC. ultrasound. and functional status of women with osteoarthritic knees: a single-blind. the authors acknowledged the low quality of evidence. which may have driven the assessors to give credit to these two trials and classify randomisation methods as adequate rather than inadequate in the absence of evidence suggesting neither of the two mutually exclusive categories.cation of the ultrasound and overall low methodological quality of the trials included. Nevertheless.53:812–20. and TENS on isokinetic strength. knee pain and function. Lucie Brosseau. Archives of Physical Medicine & Rehabilitation 2005. that “there is an accumulating body of research suggesting that ultrasound may have the potential to provide significant benefits in the treatment and management of the osteoarthritic complex”. Published by John Wiley & Sons. whereas PEDro assessors rated them as adequate. Wells were authors on the original review.Preliminary results of integrated therapy for patients with knee osteoarthritis. including animal and non randomised studies. Atalay A. pain.5(1):29–35. Effect of ultrasound on mobility in osteoarthritis of the knee. Joan Peterson. controlled trial. American Journal of Physical Medicine & Rehabilitation 2008. . Change RW. Huang 2005 A {published data only} Huang MH. and refrained from statistically summarising the data. They included five reviews and nine original studies. Falconer 1992 {published data only} ∗ Falconer J.au/). et al.Use of ultrasound to increase effectiveness of isokinetic exercise for knee osteoarthritis. until valid evidence supporting its use becomes available. Wang MC. short-wave diathermy. Chen TW. the paper seems to give a complete overview on the available evidence for therapeutic ultrasound. randomized. use adequate concealment of allocation. evidence of its clinical effectiveness in people with hip or knee OA is of poor quality and therefore inconclusive. Lin YS. experimental and sham interventions that are close to indistinguishable and an intention-to-treat analysis. Adequately sized randomised parallel-group trials in approximately 2 x 100 patients with knee or hip osteoarthritis are necessary to determine whether either continuous or pulsed ultrasound therapy is indeed associated with a clinically relevant benefit on pain and function. Srbely 2008 recently published a systematic review evaluating therapeutic ultrasound in people with osteoarthritis. ACKNOWLEDGEMENTS Vivian Welch. Lee CL. Implications for research The current systematic review is inconclusive. DurmuÅŸoÄŸlu G. Lee CL. Peter Tugwell and George A.05. Arthritis Care and Research 1992. Huang MH. which are similar in our review and in PEDro. Akman MN. We thank the Cochrane Musculoskeletal editorial team for valuable comments and Malcolm Sturdy for database support.87:443–51. health specialist should be aware of the lack of sound evidence and be reluctant to give ultrasound therapy as a routine option.

Lindahl 1952 {published data only} Lindahl O. Zeitschrift für die gesamte innere Medizin und ihre Grenzgebiete 1987. AlonsoCoello P. Vol. Morrissey MC. Boncheva I. Bloch DA. Physical therapy in degenerative diseases of the joints. Trnavsky K. Holenstein F. 10. Svarcova 1988 {published data only} Svarcova J. Effectiveness of shortwave diathermy and ultrasound in the treatment of osteoarthritis of the knee joint. Harris CL. The effects of physiotherapy on osteoarthritic knees of females.7(1):1–76. Hillsdale. Kiralp MZ. . The Journal of the Egyptian Medical Association 1975. Smith GD.Suppl. Egger 2003 Egger M. DerSimonian 1986 DerSimonian R. Hooper MM. 22 References to studies awaiting assessment Kostadinov 1978 {published data only} Kostadinov D. (1988). Reda DJ.15:169–74. Zeitschrift für ärztliche Fortbildung 1975. Jan 1991 {published data only} Jan MH. Jones 2004 {published data only} Jones JP.42:105–8. Lefebvre C.23(1):9–13.GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. 2nd Edition. Systematic Reviews in Health Care: Meta-Analyis in Context.35(1):18–20. Falck-Ytter Y. Additional references Altman 1996 Altman R. Laird N. Juni P. characterization. The Journal of Orthopaedic and Sports Physical Therapy 1986. Popov V. Kalaidjiev G. Comparative investigations on gonarthrosis treatment with some physical factors. Smith GD. et al. Bansil 1975 {published data only} Bansil CK.8:255–59.19(22): 3127–31. Scherer R. New England Journal of Medicine 2006. issue 1:202-203 (O-9). Bartlett C. Bellamy 1995 Bellamy N.58:328–33. BMJ 1994.Glucosamine. Controlled clinical trials 1986. Hartley 1993 Hartley A. Statistical power analysis for the behavioral sciences. Results from a workshop. Principles of and procedures for systematic reviews. Bellamy N. et al. Osteoarthritis Cartilage 1996.336(7650): 924–6.43):49–51. Comparison of effects of combined physical therapy program and exercise on corrupted balance functions in patient with knee bilateral osteoarthritis [Turkish]. England) 2003. [PUBMED: 3802833] Dickersin 1994 Dickersin K. Vist GE. Rheumatic diseases clinics of North America 1990. A simple method for converting an odds ratio to effect size for use in meta-analysis. NJ: Lawrence Earlbaum Associates. 2001:23–42. galvanic currents and shortwave diathermy on pain intensity in patients with osteoarthritis. 1988. chondroitin sulfate.69:43–45.References to studies excluded from this review Antich 1986 {published data only} Antich TJ. [Bulgarian].7(3):177–88. Esmat 1975 {published data only} Esmat N. Physical therapy treatment of knee extensor mechanism disorders: comparison of four treatment modalities. Therapeutic Ultrasound. Clegg 2006 Clegg DO. London: BMJ Books. Brandt K. Egger 2001 Egger M. O’Dell JR. Sterne J. Westbrook RA. and the two in combination for painful knee osteoarthritis. Etobicoke. Zvarova J. Questions of therapy and morbidity of the bony framework and the locomotor apparatus in a rural practice. Fizikalna Kurortna i Rekhabilitatsionna Meditsina 1996. Ontario. Klein MA.Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Canada: Anne Hartley Agency. Moskowitz R. Brewster CE. Altman DG editor(s). Cohen. et al. Statistics in Medicine 2000. 2004. In: Egger M.4(4):217–43. Meta-analysis in clinical trials. and stimulation of acupuncture points. Anne Hartley Agency. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Dafinova 1996 Dafinova Y.16(4):845–70.8(2): 36–37.354(8):795–808. Randall CC. Ultraphonophoretic application of voltaren emulgel in patients with knee-joint osteoarthrosis [Bulgarian]. Machalett 1975 {published data only} Machalett H. BMJ 2008. Joshi JB.90:1008–13. 1988 Cohen. Identifying relevant studies for systematic reviews. Clinical effect of ultrasonic waves in chondromalacic and osteoarthritic changes in the knee. Hicks 1990 Hicks JE.9(5):138–9. Oxman AD. Mihailov S. 1993. Rheumatism 1952. Bae YK. Scandinavian journal of rheumatology 1988. Dursun H. Lai JS. Cakar E. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study. Ozdemir B.309(6964):1286–91. Hochberg M. Lozanova M. Medical journal of Zambia 1975. Kunz R. Ltd. Treatment of arthrosis deformans by simultaneous application of interferential current and ultrasonic waves. Kurortologiya i. Exercise in patients with inflammatory arthritis and connective tissue disease. Guyatt 2008 Guyatt GH. The influence of ultrasound. Romatizma 2008. Dikova M. Fizioterapiya 1978. Published by John Wiley & Sons.22(suppl. Chinn 2000 Chinn S. Zielke 1987 {published data only} Zielke A. Outcome measurement in osteoarthritis clinical trials. 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Arden N. et al. Egger M. 1999. Pham 2004 Pham T. [PUBMED: 18316340] Yang 2005 Yang DJ. Comparison of ultrasound and short wave diathermy therapy in knee osteoarthritis [Turkish]. Zhongguo Linchuang Kangfu [Chinese Journal of Clinical Rehabilitation] 2005. Chm. Dieppe P. Basaran S. et al. Altman RD. Systematic reviews in health care: Assessing the quality of controlled clinical trials. Scherer M. Jüni 2001 Jüni P. Abramson S. Veenhof 2007 Veenhof C. Journal of Clinical Epidemiology 2001. Measuring inconsistency in meta-analyses.28(6):459–62. Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi 2006. Tendal 2009 Tendal B. Guzel R. Otman S. Bürgi U. Funnel plots for detecting bias in metaanalysis: guidelines on choice of axis. Comparison of different methods of pulsed shortwave diathermy in knee osteoarthritis. et al. Ltd. Bijlsma JWJ. 2008.Meta-analysis: chondroitin for osteoarthritis of the knee or hip. BMJ 2009.1002/ 14651858. Published by John Wiley & Sons. Sterchi R. Currier DP. Carpenter JR. Kirdi N.Higgins 2003 Higgins JP. [DOI: 10. BMJ (Clinical research ed. Schumacher M.16(2):137–62. BMJ 2003. Rücker 2008 Rücker G. Suteanu S. Reichenbach S.327(7414):557–60. [PUBMED: 18092708] Reichenbach 2007 Reichenbach S. Cochrane Handbook for Systematic Reviews of Interventions. Thompson SG. Swiss Medical Weekly 2003. Berghea F.14:86–91. Zhang 2008 Zhang W. et al. Third Edition. [PUBMED: 11440947] Jüni 2006 Jüni P. Deeks JJ.76(11): 1661–6.133: 333–8. Osteoarthritis Cartilage 2004. Hróbjartsson A. Bürgi E. Available from www. Altman DG. Anderson JJ. Issue 3.OARSI recommendations for the management of hip and knee osteoarthritis. Hochberg M. Tuzun 2003 Tuzun EH. Altman DG. Shea B. Cochrane Database of Systematic Reviews 2001. The Pain Clinic 2003. Vol. Ones N. Qin X-Y. Koke AJA. Dekker J. Goerlich C. Nüesch 2009 Nüesch E.Disagreements in meta-analyses using outcomes measured on continuous or rating scales: observer agreement study. Tetik S. 339:b3128. et al. BMC medical research methodology 2008. In: Kelly WN. Nelson 1999 Nelson RM. Osteoarthritis Research Society 2008. Wells G. Altman DG. Osteoarthritis and cartilage / OARS. Tetik C. The effects of heat on osteoarthritis of the knee. Kozanoglu 2003 Kozanoglu E. Version 5.Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: metaepidemiological study. et al. Xu FY. Short term efficacy of ibuprofen phonophoresis versus continuous ultrasound therapy in knee osteoarthritis. Moskowitz RW. Peterson J.8(1):79. Best practice & research. Oostendorp RA. American family physician 2007. Jablecki N. Sterne 2001 Sterne JA. Jüni P. Gluud LL. Philadelphia: WB Saunders. Clinical Electrotherapy.146(8):580–90. Ma L. Higgins 2008 Higgins JPT. Li XX. Rutjes AW.54(10):1046–55.15:421–27. Egger M. 1997:1383–93. Gan JH. 12(5):389–99. International Journal of Behavioral Medicine 2007. Nuki G. Osteoarthritis: rational approach to treating the individual. van der Heijde D. Kalpakcioglu 2006 Kalpakcioglu BA. Therapeutic ultrasound for osteoarthritis of the knee.org. The Pain Clinic 2006. Marchand K. Which patients with osteoarthritis of hip and/or knee benefit most from behavioral graded activity?. Part II: OARSI evidence-based. Trelle S. Trelle S. Annals of internal medicine 2007. Schwarzer G.0. Journal of the Canadian Chiropractic Association 2008. Bürgi E. [PUBMED: 18279766] References to other published versions of this review Welch 2001 Welch V. Bellamy N.20(4):721–40. BMJ 2001. BMJ 2009.336(7644): 601–5. Rand 2007 Rand SE. Zhongguo Zhenjiu 2008.18(1):67–75.339:b3244. Wood 2008 Wood L.52:30–38. Egger M.52(4):168–73.Comparative study on Chinese medicine and western medicine for treatment of osteoarthritis of the knee in Caucasian patients. Higgins JP. Nüesch E. Tugwell P. expert consensus guidelines.) 2008. Ultrasound in the management of osteoarthritis: part I: a review of the current literature. Srbely 2008 Srbely JZ. Textbook of Rheumatology. Li X-X. Appleton & Rouge. Trelle S.cochrane–handbook. [PUBMED: 19036172] Solomon 1997 Solomon L. Jüni P. Undue reliance on I2 in assessing heterogeneity may mislead. Hayes KW.323 (7303):42–6. Ones 2006 Ones K. Brosseau L. Sledge CB editor(s). . Bahadir C. Clinical rheumatology 2006.CD003132] 23 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Harris ED Jr.OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited.9:252–54. Ruddy S. Guler-Uysal F. Qin 2008 Qin XY. The physical therapy prescription. Reichenbach S. 2. Altman RD. Schulz KF. The Cochrane Collaboration. Ultrasonic wave in combination with quadriceps exercise for the treatment of senile knee osteoarthritis. Green S (eds). 5th Edition. 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with lower extremity in maximal extension Area treated per session: not reported Skin preparation: not reported (direct contact) Safety precautions: not reported Extracted pain outcome: Pain on walking after 8 weeks (VAS). minutes per treated region not reported Total sessions: 24 Frequency: 1. 3 times per week Duration of treatment period: 8 weeks Analgesics allowed. 3 times per week Control intervention: hot packs + isokinetic exercise. 16 with II. 100 patients were equally randomised in 5 groups: 1) short wave diathermy + hot packs + isokinetic Participants Interventions Outcomes Notes Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. In total. described as ’Knee pain severity after a 50-m walk’ Extracted function outcome: Lequesne OA index global score (Likert) after 8 weeks No primary outcome reported *Only 2 arms (40 patients) qualified for inclusion in this review. Published by John Wiley & Sons.∗ Indicates the major publication for the study CHARACTERISTICS OF STUDIES Characteristics of included studies [ordered by study ID] Cetin 2008 Methods Randomised controlled trial 5-arm parallel group design Trial duration: 8 weeks No power calculation reported Funding by non-profit organisation: no information provided 100 patients randomised* 100 patients with knee OA reported at baseline Study joints: 100 knees Number of females: 100 of 100 (100%) Average age: 60 years Average BMI: 28 kg/m2 Average disease duration: not reported Severity**: according to Kellgren and Lawrence: 3 patiens with grade I.5 W/cm2 Head size (cm2): not reported Treated anatomical areas: around the knee.00 MHz Intensity: 1. Ltd. Device: Sonopuls 590 US (Enraf Nonius) Type: continuous US Duration of stimulation per session: 10 minutes. 24 . 16 with grade III. unclear whether intake was similar between groups. and 5 with grade IV Experimental intervention: Ultrasound therapy + hot packs + isokinetic exercise.

double-blind trial 2-arm parallel group design Trial duration: 14. Arthritis Health Prof. who were not blinded. NIAMS Grant number AM30692 74 patients randomised Number of patients with knee OA not reported at baseline 25 Participants Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. 2) transcutaneous electrical stimulation + hot packs + isokinetic exercise. the treating health care provider must be aware of the type of ultrasound therapy given. Association. who was blinded with regard to the type of treatment the patients would receive’. Randomised. 3) Ultrasound therapy + hot packs + isokinetic exercise. No information provided. ** numbers applicable to the 40 patients included in the review Risk of bias Item Adequate sequence generation? Allocation concealment? Adequate blinding of patients? Authors’ judgement Unclear Unclear No Description No information provided. No sham intervention. Published by John Wiley & Sons. For safety reasons. 5) isokinetic exercise. Ltd. VAS and Lequesne are likely to be self reported by patients.Cetin 2008 (Continued) exercise. Funding by commercial organisation Unclear avoided? Falconer 1992 Methods No information provided. 4) hot packs + isokinetic exercise.6 weeks Power calculation reported Funding by non-profit organisation: Arthritis Foundation. No information provided. Although the investigators wrote that ’Patients were evaluated at baseline and at the end of the treatment sessions by the physician. Adequate blinding of physicians/physical No therapists? Adequate blinding of outcome assessors? Unclear Intention-to-treat analysis performed? Pain Intention-to-treat analysis performed? Function Unclear Unclear No information provided. .

4. joint protection. instruction in daily home exercise. . Primary outcome: Pain and active range of motion *not enough data presented to allow pooling. increased to maximum tolerable dosage. Altman grade II. active ROM and isometric strengthening exercises. manual therapy. lateral. 3 minutes per treated region Total sessions: 12 Frequency: 1. 2-3 times per week Control intervention: sham ultrasound therapy. at which warmth without pain was felt. 26 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.00 MHz Intensity: mean 1.5 W/cm2 Head size (cm2): 10 (effective radiating surface 8. Falconer was unable to locate the original data file and to provide additional data.Falconer 1992 (Continued) Study joints analysed: 69 Number of females: 50 of 69 (72%) Average age: 68 years Average BMI: not reported Average disease duration: 6. In personal communication Dr Falconer indicated that permuted block randomisation was used. Outcomes Notes Risk of bias Item Adequate sequence generation? Authors’ judgement Unclear Description No information provided. most likely pulsed ultrasound therapy Duration of stimulation per session: 12 minutes.5W/cm2 Extracted pain outcome: Global pain at 6 weeks. 8 patients had history of total knee replacement Interventions Experimental intervention: ultrasound therapy. depending on which end range presented with the most functional loss Area treated per session: 100cm2 Skin preparation: aqueous gel Safety precautions: power increased in 0. but in light of the maximal intensity reported.1W/cm2 increments to a maximum of 2. measured on 10 cm VAS. with lower extremity in maximal flexion or extension. Despite a great effort. Dr. described as ’pain’. Published by John Wiley & Sons.5) Treated anatomical areas: anterior.7 W/cm2. Ltd. posterior.5) Severity: moderate knee OA. 2-3 times per week Concurrent Treatment (30 minutes): passive stretch during cooling period. Duration of treatment period: 6 weeks Unclear whether analgesics were allowed and the intake was assessed Device: Sonopulus 590 (Enraf Nonius) Type: not reported. Control: 7.95 years (US: 6. described as ’gait velocity’. not exceeding 2. medial. it was only stated that no significant differences were observed between the experimental and control group. Extracted function outcome*: Walking disability at 6 weeks.

Altman grade II Experimental intervention: Ultrasound therapy. ranging from 5 months to 12 years Severity: moderate knee OA. Adequate blinding of physicians/physical No therapists? Adequate blinding of outcome assessors? Intention-to-treat analysis performed? Pain Yes No 34 out of 37 (92%) randomised to experimental and 35 out of 37 (95%) randomised to control group were analysed. hot packs. Sham device: identical in appearance.Falconer 1992 (Continued) Allocation concealment? Adequate blinding of patients? Unclear Yes No information provided. the treating health care provider must be aware of the type of ultrasound therapy given. Intention-to-treat analysis performed? Function No Funding by commercial organisation Unclear avoided? Huang 2005 A Methods Randomised trial 4-arm parallel group design Trial duration: 8 weeks No power calculation reported Funding by non-profit organisation: Supported by a project grant provided from the National Science Council of Taiwan 140 patients randomised* 140 patients with bilateral knee OA reported at baseline Study joints: 280 knees for pain outcome Number of females: 113 of 140 (81%) Average age: 65 years Average BMI: not reported Average disease duration: not reported. Published by John Wiley & Sons. Ltd. three times per week Control intervention: isokinetic exercise and hot packs. isokinetic exercise. 5 minutes per treated to each treated region 27 Participants Interventions Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. dials were lit and audible beeps were given at each sham increase in dosage. trial did not contribute to function meta-analyses. . No energy delivered to tissue. Not applicable. For safety reasons. No information provided. three times per week Duration of treatment period: 8 weeks Unclear whether analgesics were allowed and the intake was assessed Device: Sonopulus 590 (Enraf Nonius) Duration of stimulation per session: unclear.

Although authors wrote that they used sequentially numbered opaque sealed envelopes. and the popliteal fossa tender points (5min/area).5 W/cm2 Head size (cm2): not reported Treated anatomical areas: medial collateral ligament. we had no evidence to suggest that the envelopes were appropriately numbered in a sequential manner and random allocation could therefore have been undermined. Published by John Wiley & Sons. with lower extremity in 90º flexion for first 2 areas and maximal extension for popliteal fossa points Area treated per session: 25cm2 Skin prep: not reported Safety precautions: none reported Outcomes Extracted pain outcome: Pain on walking at 8 weeks. Primary outcome: not reported *2 arms (70 patients) were excluded from the review: no intervention arm (35 patients) and isokinetic exercise + pulsed ultrasound + intraarticular hyaluronan + hot packs arm (35 patients). Quote: ’and randomly assigned to 4 groups (groups I-IV) by a secure system of opaque sealed envelopes that were sequentially numbered I-IV.00 MHz Intensity: up to a level at which a warm sensation or a mild sting was felt. No sham intervention. Notes Risk of bias Item Adequate sequence generation? Allocation concealment? Authors’ judgement Unclear Unclear Description No information provided. measured on 0 to 26 Likert scale. not exceeding 2.’ With 140 patients randomised. The doctor who assigned the patients was blinded to the treatment the patients would receive. Extracted function outcome: Lequesne’s Index after 8 weeks. Ltd. the envelopes should have been sequentially numbered 1-140 and not I to IV.Huang 2005 A (Continued) Total sessions: 24 planned Frequency: 1. 28 . described as ’severity of knee pain while remaining in a weight-bearing position (walking or standing) for 5 minutes’. anserine bursa. measured on 10 cm VAS. Adequate blinding of patients? No Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.

however. Published by John Wiley & Sons. Ltd.Huang 2005 A (Continued) Adequate blinding of physicians/physical No therapists? Adequate blinding of outcome assessors? Unclear No sham intervention. ranging from 6 months to 11 years Severity: moderate knee OA. 32 out of 35 (91%) randomised to experimental and 30 out of 35 (86%) randomised to control group were analysed (analysis on patient level). . isokinetic exercise. Quote: ’All the evaluations were performed by the same physiatrists who were also blinded to the treatment the patients received’. isokinetic exercise and hot packs. Altman grade II Comparison 1: Experimental intervention: continuous ultrasound therapy. Intention-to-treat analysis performed? Pain No Intention-to-treat analysis performed? Function No Funding by commercial organisation Unclear avoided? Huang 2005 B Methods Randomised trial 4-arm parallel group design Trial duration: 8 weeks No power calculation reported Funding by non-profit organisation: Supported by a project grant provided from the National Science Council of Taiwan (grant number NSC-92-2314-B-037-067) 120 patients randomised* 120 patients with bilateral knee OA reported at baseline Study joints: 240 knees for pain outcome Number of females: 97 of 120 (81%) Average age: 62 years Average BMI: not reported Average disease duration: not reported. No information provided. as a VAS was used for pain. 64 out of 70 (91%) randomised to experimental and 60 out of 70 (86%) randomised to control group were analysed (analysis on knee level). We scored unclear for both pain and function. three times per week Control intervention: sham ultrasound therapy. hot packs. and Lequesne for function that are usually scored by the patient. who was not blinded. three times per week 29 Participants Interventions Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.

Extracted function outcome: Lequesne’s Index after 8 weeks.5 W/cm2 Head size (cm2): not reported Treated anatomical areas: medial collateral ligament. hot packs. was excluded from the review Notes Risk of bias Item Adequate sequence generation? Allocation concealment? Authors’ judgement Unclear Unclear Description No information provided. measured on 10 cm VAS. isokinetic exercise. Ltd. 5 minutes per treated to each treated region Total sessions: 24 planned Frequency: 1. Published by John Wiley & Sons. not exceeding 2. Primary outcome: Change in ambulation speed and Lequesne index *1 arm (30 patients). anserine bursa. with lower extremity in 90º flexion for first 2 areas and maximal extension for popliteal fossa points Area treated per session: 25cm2 Skin prep: not reported Safety precautions: none reported Outcomes Extracted pain outcome: Pain on walking at 8 weeks.Huang 2005 B (Continued) Comparison 2: Experimental intervention: pulsed ultrasound therapy. described as ’severity of knee pain while remaining in a weight-bearing position (walking or standing) for 5 minutes in the parallel bars of the treadmill’. Quote: ’they were randomly assigned to 4 groups by a secure system of sequentially numbered I through IV opaque sealed envelopes. in which no intervention was given. measured on 0 to 26 Likert scale. three times per week Control intervention: sham ultrasound therapy. The physician who assigned the patients was blinded as to the treatment they would receive. we had no evidence to suggest that the envelopes were appropriately numbered in a sequential manner and random allocation could therefore have been undermined. three times per week Duration of treatment period: 8 weeks Unclear whether analgesics were allowed and the intake was assessed Device: Sonopulus 590 (Enraf Nonius) Duration of stimulation per session: unclear. isokinetic exercise and hot packs.’ 30 Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.00 MHz Intensity: up to a level at which a warm sensation or a mild sting was felt. Although authors wrote that they used sequentially numbered opaque sealed envelopes. and the popliteal fossa tender points (5min/area). .

who were not blinded. Comparison I: 27 out of 30 (90%) randomised to experimental and 25 out of 30 (83%) randomised to control group were analysed. Ltd. but the investigators stated ’(. Analyses performed on knee level. ATL ultrasound and Enraf Nonius.) however.Huang 2005 B (Continued) With 120 patients randomised.. Analyses performed on patient level. Adequate blinding of physicians/physical No therapists? Adequate blinding of outcome assessors? No Intention-to-treat analysis performed? Pain No Intention-to-treat analysis performed? Function No Funding by commercial organisation Unclear avoided? Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.. Comparison I: 54 out of 60 (90%) randomised to experimental and 50 out of 60 (83%) randomised to control group were analysed. Comparison II: 60 out of 60 (100%) randomised to experimental and 50 out of 60 (83%) randomised to control group were analysed. For function: no information provided. For Pain: VAS is usually scored by patients. the absence of a warm or stinging sensation for the treated patients caused the failure of the sham US application. 31 . the envelopes should have been sequentially numbered 1-120 and not I to IV.’ For safety reasons. Published by John Wiley & Sons. Adequate blinding of patients? No Sham intervention given in the control group. Comparison II: 30 out of 30 (100%) randomised to experimental and 25 out of 30 (83%) randomised to control group were analysed. the treating health care provider must be aware of the type of ultrasound therapy given. Treatment equipment supplied by Chattecx group.

measured on 0 to 20 Likert scale Extracted function outcome: WOMAC physical function subscale at 2 weeks.00 MHz Intensity: 1 W/cm2 Head size: 4 cm Treated anatomical areas: patellofemoral and tibiofemoral borders of the target knee on both the lateral and medial margins. five times per week Control intervention: sham ultrasound therapy. 32 . Published by John Wiley & Sons. 2 days after end of last treatment. five times per week Duration of treatment period: 2 weeks Analgesics were not allowed. Ltd.250 ultrasound equipment Duration of stimulation per session: 5 minutes Total sessions: 10 Frequency: 1.Özgönenel 2009 Methods Randomised trial 2-arm parallel group design Trial duration: 2 weeks Power calculation reported Funding by non-profit organisation: No information provided 67 patients randomised 67 patients with newly diagnosed knee OA reported at baseline Study joints: 67 knees Number of females: 54 of 67 (81%) Average age: 55 years Average BMI: 32 kg/m2 Average disease duration: not reported. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. 2 days after end of last treatment. but all patients were newly diagnosed with OA Severity: knee pain and limitation on most days of the past 6 months and KellgrenLawrence score II (31 patients) to III (36 patients) Experimental intervention: continuous ultrasound therapy. measured on 0 to 68 Likert scale Primary outcome reported: knee pain on movement over the past week. measured on 10 cm VAS Participants Interventions Outcomes Notes Risk of bias Item Adequate sequence generation? Authors’ judgement Unclear Description No information provided. two patients were dropped out from the control group due to analgesic intake Device: Petson . avoiding the patella Area treated per session: 25cm2 Skin prep: Aqueous gel Safety precautions: circular movements Extracted pain outcome: WOMAC pain subscale at 2 weeks.

that are usually scored by the patient.”.Özgönenel 2009 (Continued) Allocation concealment? Unclear Authors merely state that “An independent researcher not involved in the data assessment randomized the subjects. two patients used analgesics because of increased pain and were thus dropped out of the study. In this trial. Ltd.”. No information provided. No information provided. patients were blinded. the treating health care provider must be aware of the type of ultrasound therapy given. It was only reported that “In the placebo group. Published by John Wiley & Sons. It was only reported that “In the placebo group. For safety reasons. two patients used analgesics because of increased pain and were thus dropped out of the study. No information provided. Adequate blinding of patients? Yes Adequate blinding of physicians/physical No therapists? Adequate blinding of outcome assessors? Yes Intention-to-treat analysis performed? Pain Unclear Intention-to-treat analysis performed? Function Unclear Funding by commercial organisation Unclear avoided? Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Sham device: identical in appearance. Quotes: “An applicator disconnected from the back to working ultrasound machine”.”. 33 . Pain and function were measured on WOMAC subscales. Patient in position unable to see whether the cable was disconnected or not. Quote: “Both the therapeutic US and the sham US application were performed by the same therapist and patients were assessed by three blinded researchers before and at the end of therapy program”.

Use of active control group. Quote: ’An attempt is made for comparative assessment of the most commonly used physical factors in the treatment of gonarthrosis patients. Unclear whether allocation of treatment was at random. Additional description: RCT. . Published by John Wiley & Sons. Not a randomised study. Additional description: 3 arm parallel group design comparing ultrasound therapy to interferential current stimulation or ultrasound therapy with interferential current stimulation. Ltd. phonophoresis. iontophoresis and ultrasound therapy + ice. Additional description: report summarising percentages of any type of active or passive treatment option given to patients with osteoarthritis during a course of treatment in the state health resorts Bad Brambach--Bad Elster in 1979 to 1981. Additional description: study design unclear and unclear whether people with osteoarthritis were included. infrapatellar tendinitis and peripatellar pain. No relevant outcome reported. Results presented jointly.. parallel design.. Additional description: controlled trial with groups receiving either Galvanic electrostimulation or ultrasound therapy or pulsed short wave diathermy. Additional description: RCT with 2 arm parallel group design comparing ultrasound therapy with shortwave diathermy. two arms comparing ultrasound therapy versus sham ultrasound therapy in people with chondromalacic and osteoarthritic knee conditions. Use of active control group. Unable to extract data for osteoarthritis. No contact could be established with the author. Additional description: RCT with 4-arm parallel group design comparing ice. The objects of the investigation were the widely used (in Bulgaria) physical factors (.Characteristics of excluded studies [ordered by study ID] Antich 1986 Not osteoarthritis but several types of knee extensor mechanism disorders described as chondromalacia patella. Not a randomised study (historical case series) Use of active control groups. Additional description: RCT with 4 arm parallel group design comparing ultrasound therapy versus short wave diathermy or ultrasound therapy + exercise or diathermy + exercise. Magnetimpulsator and a bipolar electrostimulator Interferential current (electro)stimulation Therapeutic Ultrasound Phonophoresis with hydrocortisone 34 Participants Interventions Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Bansil 1975 Esmat 1975 Jan 1991 Jones 2004 Lindahl 1952 Machalett 1975 Svarcova 1988 Zielke 1987 Characteristics of studies awaiting assessment [ordered by study ID] Kostadinov 1978 Methods Most likely comparative study with historical controls or cohort study.)’ 427 in.and outpatients with osteoarthritis of the knee Mineral-oil electrophoresis and low frequency impulse currents Device: Bipulsator. Use of active control group.

Published by John Wiley & Sons. 35 . We have not yet been able to involve a Bulgarian translator. Notes Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.Kostadinov 1978 (Continued) Electrophoresis with KJ and novocaine Outcomes Awaiting translation Function was described as ’locomotion’ Publication in Bulgarian. Ltd.

21. Mean Difference (Random.95% CI Weight Std.38 [ -0.3 % 21.6 % 20.95% CI Cetin 2008 Falconer 1992 Huang 2005 A Huang 2005 B zgnenel 2009 20 34 32 57 34 0.11 ] Total (95% CI) Heterogeneity: Tau2 = 0.49 [ -0. 0. Chi2 = 5.32) -0. 0.1. -0. 36 .42. -0. Mean Difference (SE) Std. Ltd.76.DATA AND ANALYSES Comparison 1.23 ] -4 -2 0 2 4 Favours ultrasound Favours control Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.Random. -0.24) -0. 0.58.68 ] -0. Mean Difference IV. 95% CI) Std.25). Random. df = 4 (P = 0.64 [-1.1 % 21. 0. 95% CI) Not estimable Analysis 1. Comparison 1 Any type of therapeutic ultrasound versus control.23] -0.14] Not estimable Not estimable 2 136 Risk Ratio (IV.38 (0.00030) 100.45 (0.72 [ -1.81 [ -1.87. Published by John Wiley & Sons.25) 14.92.81 (0. of studies 5 4 1 1 No.30 ] -0. Fixed. Fixed.3 % 0. Mean Difference IV.02 ] -0.02.23 ] -0. Review: Therapeutic ultrasound for osteoarthritis of the knee or hip Comparison: 1 Any type of therapeutic ultrasound versus control Outcome: 1 Pain Study or subgroup Experimental N Control N 20 35 30 25 33 Std.25) -0.26) -0.72 (0.05 [ -0.49 [-0. Outcome 1 Pain.42. 95% CI) Risk Ratio (IV. -0.76.32. 95% CI) Effect size -0.45 [ -0. Any type of therapeutic ultrasound versus control No.0 % -0. 95% CI) Risk Ratio (IV.6 % 22.Random.05 (0. I2 =26% Test for overall effect: Z = 3. Mean Difference (Random.62 (P = 0. of participants 320 251 67 67 Outcome or subgroup title 1 Pain 2 Function 3 Number of patients experiencing any adverse event 4 Number of patients withdrawn or dropped out due to adverse events 5 Number of patients experiencing any serious adverse event Statistical method Std.

7 % 0.1 1 10 100 Favours experimental Favours control Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.96 ] -1. Mean Difference IV. Published by John Wiley & Sons. -1. Outcome 3 Number of patients experiencing any adverse event. I2 =88% Test for overall effect: Z = 1.0 [ 0.25) 24.14 ] -4 -2 0 2 4 Favours ultrasound Favours control Analysis 1. -0.Random. 0.1 % 24. 0.90 [ -1. Outcome 2 Function.Random.42.71.22 ] Total (95% CI) Heterogeneity: Tau2 = 0.0.33 (0.0 (P < 0.32) -1.01 0.39.0.28.41 ] -0.10 ] -0.76.0 [ 0.Analysis 1. 37 .69 [ -2.2. Review: Therapeutic ultrasound for osteoarthritis of the knee or hip Comparison: 1 Any type of therapeutic ultrasound versus control Outcome: 2 Function Study or subgroup Ultrasound N Control N 20 30 25 33 Std. 0 (Control) Heterogeneity: not applicable Test for overall effect: Z = 0.00002). Mean Difference IV.69 (0. Ltd.7 % 25.0 ] 0.00001) 34 33 0.60 (P = 0. Mean Difference (SE) Std.56. Comparison 1 Any type of therapeutic ultrasound versus control.6 % 25.3.27 [ -0.95% CI 0.33 [ -0.0 % -0.64 [ -1.9 (0. 0.3) -0.30.95% CI Risk Ratio IV. Comparison 1 Any type of therapeutic ultrasound versus control.95% CI Weight Std. Chi2 = 24.Fixed.0 ] zgnenel 2009 0/34 Total (95% CI) Total events: 0 (Experimental).95% CI Cetin 2008 Huang 2005 A Huang 2005 B zgnenel 2009 20 32 57 34 0. Review: Therapeutic ultrasound for osteoarthritis of the knee or hip Comparison: 1 Any type of therapeutic ultrasound versus control Outcome: 3 Number of patients experiencing any adverse event Study or subgroup Experimental n/N Control n/N 0/33 Risk Ratio IV.11) 100. 0. 0. df = 3 (P = 0.27 (0.Fixed.25) -0.

0.0 [ 0. Review: Therapeutic ultrasound for osteoarthritis of the knee or hip Comparison: 1 Any type of therapeutic ultrasound versus control Outcome: 4 Number of patients withdrawn or dropped out due to adverse events Study or subgroup Experimental n/N Control n/N 0/33 Risk Ratio IV.0.0 (P < 0.Fixed.0.95% CI 0.0 ] 0. Comparison 1 Any type of therapeutic ultrasound versus control. 38 .5.0 ] Falconer 1992 zgnenel 2009 0/34 0/34 Total (95% CI) Total events: 0 (Experimental).0 ] 0. Outcome 4 Number of patients withdrawn or dropped out due to adverse events. Comparison 1 Any type of therapeutic ultrasound versus control.01 0. Review: Therapeutic ultrasound for osteoarthritis of the knee or hip Comparison: 1 Any type of therapeutic ultrasound versus control Outcome: 5 Number of patients experiencing any serious adverse event Study or subgroup Experimental n/N Control n/N 0/35 0/33 Risk Ratio IV. Published by John Wiley & Sons.1 1 10 100 Favours experimental Favours control Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.00001) 34 33 0.00001).0% Test for overall effect: Z = 0.Analysis 1. 0 (Control) Heterogeneity: not applicable Test for overall effect: Z = 0.Random.Fixed. 0.0.4. 0.1 1 10 100 Favours experimental Favours control Analysis 1. Outcome 5 Number of patients experiencing any serious adverse event.95% CI Risk Ratio IV. I2 =0.00001) 0.0 [ 0.0 [ 0.Random.0 ] Heterogeneity: Tau2 = ï½. df = 0 (P<0. Chi2 = 0.0 ] zgnenel 2009 0/34 Total (95% CI) Total events: 0 (Experimental). 0. 0.0. Ltd.95% CI Risk Ratio IV.0 [ 0.95% CI 0.0 (P < 0. 0 (Control) 68 68 0. 0.01 0.0.0 [ 0.

ab. clinical trial.sh. 19. (MH “Prospective Studies+”) 20.sh. (clin$ adj25 trial$). . 14. 10.sh.ti. TX joint$ n3 pain$ 34. 6.ti. TX (sing$ n25 mask$) 7. TX joint$ n3 ach$ 37. 26. 3. arthrot$.ab. TX coxarthriti$ 28.ti. exp evaluation studies/ 17.sh. 13. 24.ti.ti. (clin$ adj25 trial$). 7. exp clinical trials/ 6.sh. TX (tripl$ n25 mask$) 13. ((knee$ or hip$ or joint$) adj3 (pain$ or ach$ or discomfort$)). research design.sh.pt.ab. MEDLINE. 7. (MH “Osteoarthritis”) 24.sh. TX knee$ n3 discomfort$ 38. 5. 24.sh. TX random$ 16. methodology.ti.ti.ab. (MH “Comparative Studies”) 18. 15. prospective studies. TX gonarthriti$ 26. TX hip$ n3 discomfort$ 39 Search terms for Osteoarthritis 20. 11.pt.sh. 5. coxarthriti$.ti. comparative study. ((knee$ or hip$ or joint$) adj3 stiff$) .ab.ti.ab. 8. randomization.ti.sh.sh. Published by John Wiley & Sons. 2.sh.ab. 4. arthros$. 21. ((knee$ or hip$ or joint$) adj3 (pain$ or ach$ or discomfort$)).ab. random allocation.ti. double blind procedure.sh. OVID EMBASE Search terms for design 1.sh. TX (trebl$ n25 mask$) 11. arthros$. 8. Ltd.sh. 15.ab. exp clinical trial/ 9. 25. prospective study.sh.ab.ab. TX osteoarthro$ 25. 16. 30.sh.sh. placebos. TX (control$ or prospectiv$ or volunteer$) 21. placebo$. TX arthrot$ 31.ab.ti. S1 or S2 or (……. TX knee$ n3 ach$ 35. 23. 12. TX (trebl$ n25 blind$) 10.sh. 4. placebo$. EMBASE and Cinahl search strategy OVID MEDLINE Search terms for design 1. exp evaluation studies/ 14. Search terms for Osteoarthritis 17.ab. double blind method. TX coxarthro$ 29. osteoarthro$. single blind procedure. 22.pt. controlled clinical trial.sh. 12. 18. TX (sing$ n25 blind$) 6.ab. random$.sh.sh. osteoarthro$. TX gonarthro$ 27.ab.ab.sh.ti.ti. TX arthros$ 30. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)). comparative study. placebo.ti.ti. single blind method.ti.ab.ab.ab. TX placebo$ 15. gonarthro$. exp osteoarthritis/ 18.ti. exp osteoarthritis/ 21. coxarthro$.ab. TX knee$ n3 pain$ 32. (control$ or prospectiv$ or volunteer$). 27. randomized controlled trial. TX (doubl$ n25 mask$) 9.ti. CINAHL through EBSCOhost Search terms for design 1. 28.ab. TX (tripl$ n25 blind$) 12. 23.ti.ti. randomized controlled trial. coxarthro$. (MH “Placebos”) 14.sh. follow up studies.ab.ab. (MH “Study Design+”) 17. osteoarthriti$ 23.sh. 11. 27.sh. TX hip$ n3 ach$ 36. 13. osteoarthriti$.ti. ((knee$ or hip$ or joint$) adj3 stiff$). 20. TX hip$ n3 pain$ 33. 10. 26. TX (clin$ n25 trial$) 5.ab. 9. (MH “Random Assignment”) 3.ab. (MH “Double-Blind Studies”) or (MH “Single-Blind Studies”) 4.ti.sh.) or S20 Search terms for Osteoarthritis 22. (MH “Evaluation Research”) 19.ab. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)). 25. gonarthriti$. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. 3.ti. coxarthriti$. TX (doubl$ n25 blind$) 8. random$.ab. 29. 22.ti.sh.ab.sh. osteoarthriti$. 16. randomized controlled trial.ti.ti.ti. follow up.ab. (control$ or prospectiv$ or volunteer$).ab.ti.sh.ti. (MH “Clinical Trials+”) 2. gonarthro$. arthrot$. 2. 19. gonarthriti$.APPENDICES Appendix 1.

Method: clinical trial 3. short wave therapy.tw.tw. and/33-35 37. Combination 1. exp Ultrasonic Therapy/ 30. 37 not 38 40. Search terms for Therapeutic Ultrasound 44 exp ULTRASONOGRAPHY/ 45 exp Ultrasonic Therapy/ 46 (ultrasound$ or ultrasonic$). 40 not 43 Search terms for Therapeutic Ultrasound 28.tw.fs. CENTRAL and PEDro search strategy CENTRAL Search terms for Osteoarthritis #1. and 2. and 4. and 2. TX joint$ n3 stiff$ 43. exp Ultrasonic Therapy/ 33. MeSH descriptor Osteoarthritis explode all trees Search terms for TENS #3 short wave therapy in Clinical Trials #4 ultrasonograph in Clinical Trials #5 (ultrasound* or ultrasonic*)in Clinical Trials #6 MeSH descriptor Ultrasonography explode all trees #7 MeSH descriptor Short-Wave Therapy explode all trees Combining terms #8.. 47 short wave therapy. and 2.tw. TX hip$ n3 stiff$ 42.or S42 Search terms for Therapeutic Ultrasound 31. Ltd. exp ultrasonography/ 32.tw. short wave therapy in title or abstract 2. Combination 1. Body part lower leg or knee Combination 1. animal/ and human/ 39. animal/ and human/ 43.) or S48 Combining terms S21 and S43 and S49 Combining terms 33. or/31-36 40. or/28-32 36. 32. Published by John Wiley & Sons. and 4.tw. and 3.tw. short wave therapy. or/1-16 34. and/37-39 41. 35. 34. Body part: thigh or hip 4. S22 or S23 or S24…. 36 not 39 Appendix 2. TX knee$ n3 stiff$ 41. 1. and 3. (ultrasound$ or ultrasonic$). Combining terms 37. ultrasonograph$.tw. Body part lower leg or knee Combination 1. 36. exp ultrasonography/ 29.tw.. Body part: thigh or hip 4. or/20-30 39. Method: clinical trial 3. (#1 OR #2) PEDro 1. 40 . or/1-19 38. animal/ 38. and 2. Combine all Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. 31. 48 ultrasonograph$. us. (osteoarthritis* OR osteoarthro* OR gonarthriti* OR gonarthro* OR coxarthriti* OR coxarthro* OR arthros* OR arthrot* OR ((knee* OR hip* OR joint*) near/3 (pain* OR ach* OR discomfort*)) OR ((knee* OR hip* OR joint*) near/3 stiff*)) in Clinical Trials #2. (ultrasound$ or ultrasonic$). or/17-27 35. ultrasonograph$. Ultra in title or abstract 2. (#3 OR #4 OR #5 OR #6 OR #7) #9. animal/ 42. 41 not 42 44.(Continued) 39. 49 S44 or S45 or (. TX joint$ n3 discomfort$ 40.

We updated the search and applied more strict selection criteria. characteristics of electrostimulation. use of a random-effects model. 2001 2 May 2001 New citation required and conclusions have changed Substantive amendment Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. Ltd. Published by John Wiley & Sons. whereas this version shows a statistically significant effect on pain. 23 July 2009 23 July 2009 New search has been performed New citation required and conclusions have changed 4 additional trials included Change in authors and conclusions. and investigations of funnel plots. intention-totreat analysis. including concealment of allocation. (#8 AND #9) in Clinical Trials WHAT’S NEW Last assessed as up-to-date: 22 July 2009. CMSG ID C087-R 1 May 2008 Amended HISTORY Review first published: Issue 3. blinding. detailed exploration of sources of variation between trials. We used more detailed quality assessment of component trials. 41 . use of end of trial estimates to calculate SMDs. The previous version included only one trial comparing therapeutic ultrasound with a sham intervention and found a statistically non-significant beneficial effects on pain and function. although we are uncertain about the exact magnitude of the effect.(Continued) #10. which resulted in 4 additional trials and the exclusion of 2 studies previously included.

University or Bern. did not result in a specific publication in the Cochrane database. Nüesch. Nüesch. Rutjes. Nüesch. Intramural grants External sources • Swiss National Science Foundation. we generated a standard protocol for this. as an update. Nüesch. but. Switzerland. National Research Program 53 on musculoskeletal health (grant numbers 4053-40-104762/3 and 3200-066378) DIFFERENCES BETWEEN PROTOCOL AND REVIEW Before embarking on this review. 42 . In addition. Published by John Wiley & Sons. Jüni Critical revision of the manuscript for important intellectual content:: Rutjes. Sterchi. Jüni Protocol development: Rutjes. Ltd. The protocol was approved by the Editorial Board of the Cochrane Musculoskeletal Review Group (CMSG). Jüni Drafting of the manuscript: Rutjes. Jüni Obtained funding: Jüni DECLARATIONS OF INTEREST None SOURCES OF SUPPORT Internal sources • Institute of Social and Preventive Medicine. Because of the low number of trials identified. Jüni Acquisition of data: Rutjes. and all other Cochrane reviews performed by our group. Switzerland. Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration. we used risk of bias tables to present the methodological quality of included trials and a summary of findings table to present results. we deviated from the standard protocol in terms of omitting several stratified analyses and univariable random-effects meta-regression analyses to determine whether treatment effects were affected by treatment or design characteristics. Jüni Statistical analysis. Nüesch.CONTRIBUTIONS OF AUTHORS Study conception: Rutjes. Sterchi Analysis and interpretation of data: Rutjes.

Osteoarthritis. Humans Therapeutic ultrasound for osteoarthritis of the knee or hip (Review) Copyright © 2010 The Cochrane Collaboration.INDEX TERMS Medical Subject Headings (MeSH) ∗ Ultrasonic Therapy. 43 . Short-Wave Therapy MeSH check words Adult. Ltd. Published by John Wiley & Sons. Clinical Trials as Topic. Knee [∗ therapy].