Professional Documents
Culture Documents
It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, log
means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use i
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies
(either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other
©
COPYRIGHT 2018 EDIZIONI MINERVA MEDICA
© 2017 EDIZIONI MINERVA MEDICA European Journal of Physical and Rehabilitation Medicine 2018 June;54(3):351-7
Online version at http://www.minervamedica.it DOI: 10.23736/S1973-9087.17.04743-8
ORIGINAL ARTICLE
Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Training and Research
Hospital, Istanbul, Turkey
*Corresponding author: Tuba Nazligul, Fatih Sultan Mehmet Egitim ve Arastirma Hastanesi Istanbul, Atasehir, Turkey. E-mail: drtuba_@hotmail.com
ABSTRACT
BACKGROUND: Although interferential current (IFC) is a common electrotherapeutic modality used to treat musculoskeletal pain, there is not
any randomized controlled trial investigating its clinical efficacy in subacromial impingement syndrome (SAIS).
AIM: Investigation of effectiveness of IFC treatment in patients with SAIS.
DESIGN: Randomized, double-blind, sham-controlled study.
SETTING: Physical medicine and rehabilitation outpatient clinic.
POPULATION: Patients (N.=65) between 25 and 65 years of age, with a diagnosis of SAIS according to clinical evaluation and subacromial
injection test.
METHODS: Patients were randomly distributed into two groups: 1) active IFC group (N.=33); 2) sham IFC group (N.=32). Exercise, cryo-
therapy, and a non-steroidal anti-inflammatory drug (NSAID) were given to both groups. Ten sessions of IFC with bipolar method were applied
to the active IFC group daily 20 minutes per session, 5 days per week, for 2 weeks while sham IFC was applied to the sham IFC group with the
same protocol. Visual Analog Scale (VAS), Constant scores, and Shoulder Disability Questionnaire (SDQ) were used for evaluation at baseline,
immediately post-treatment, and 1 month post-treatment. Both the patients and the researcher who assessed the outcomes were blinded to the
treatment protocol throughout the study period.
RESULTS: Sixty of the 65 patients (active IFC group N.=30, sham IFC group N.=30) completed the study, 3 patients from active IFC, 2 from
sham IFC group dropped during the follow up period. Statistically significant improvement was observed in all parameters of both groups im-
mediately and 1 month post-treatment (P<0.01). There were no statistical differences between the active IFC group and sham IFC group in all
outcome parameters (P>0.05).
CONCLUSIONS: Our results demonstrated that IFC therapy does not provide additional benefit to NSAID, cryotherapy, and exercise program
in treatment of SAIS.
CLINICAL REHABILITATION IMPACT: Our study responds to the needs of the lack of evidence in the field of rehabilitation. IFC therapy does
not provide additional benefit for the treatment of SAIS.
(Cite this article as: Nazligul T, Akpinar P, Aktas I, Unlu Ozkan F, Cagliyan Hartevioglu H. The effect of interferential current therapy on patients with
subacromial impingement syndrome: a randomized, double-blind, sham-controlled study. Eur J Phys Rehabil Med 2018;54:351-7. DOI: 10.23736/
S1973-9087.17.04743-8)
Key words: Electric stimulation therapy - Shoulder impingement syndrome - Shoulder pain.
been found to range between 6.6 to 25 per 1000 people in meral head and the coracoacromial arcus. The underlying
various studies and subacromial impingement syndrome pathology in SAIS may present as edema, bleeding, fibro-
(SAIS) has been reported to be one of the most frequent sis, tendinitis, and partial or complete rupture of the rota-
etiologic factor for shoulder pain.1 SAIS is known to occur tor cuff tendons, depending on the stage of the syndrome.2
SAIS may develop as a result of several conditions such as G/5 mL needle into subacromial space just under acromi-
weakness of rotator cuff muscles, abnormality of the acro- on using anterior approach by the same physiatrist during
mion, repetitive trauma, and overuse of the shoulder. It is the SIT procedure. A positive response was determined by
characterized by shoulder pain accompanied by restriction 80% or more postinjection reduction in pain intensity and
of the shoulder range of motion (ROM) and disability in improvement in passive and/or active ROM 15 minutes
daily life activities.3 after the injection. The diagnosis of SAIS was confirmed if
A conservative approach comprising non-steroid SIT and shoulder impingement tests (Neer and Hawkins-
anti-inflammatory drugs (NSAIDs), subacromial in- Kennedy) were positive.7, 8
jections, exercise, and several physical therapy agents The exclusion criterias were as follows: 1) concomi-
is recommended as the first step treatment for SAIS.4 tant shoulder pathologies such as adhesive capsulitis, cal-
Interferential current (IFC) therapy has been used for cific tendinitis, full-thickness tears of the rotator cuff, os-
many years in the treatment of musculoskeletal disor- teoarthritis of the acromioclavicular joint, dislocations or
ders for its analgesic, anti-inflammatory, sympatholytic, acute traumatic conditions; 2) prior applications of phys-
local vasodilating, and muscle stimulating effects. Its iotherapy and injection of hyaluronic acid and/or cortico-
effect depends on creation of a low-frequency current steroid during the preceding 3 months; 3) previous shoul-
activity in deep tissues by two medium-frequency alter- der surgery; 4) cervical pain or other conditions such as
native currents of different frequency levels.5 fibromyalgia conflicting the clinical picture; 5) malig-
Although IFC has been shown to be effective in sev- nancy; 6) neurologic motor and/or sensory deficiency in
eral musculoskeletal problems such as knee osteoarthritis the upper extremity; 7) pregnancy; 8) acute infection; 9)
and chronic back pain, there is not any randomized and inflammatory disease; and 10) cardiac pace-maker.
placebo-controlled study performed to assess its effect on Sixty-five patients who were found eligible for the
the treatment of SAIS.6 The purpose of this study was to study were randomly allocated into the active IFC
investigate the role of IFC therapy in SAIS patients. (N.=33) and sham IFC (N.=32) groups. All baseline and
post-treatment evaluations were done by the same phys-
Materials and methods iatrist with more than 5 years of clinical experience. Both
Design overview
Enrollment Assessed for eligibility (N.=110)
A double-blind, sham-controlled clinical trial was carried
out to investigate the effects of IFC therapy on SAIS. The Excluded (N.=45)
- Not meeting inclusion criteria
trial had 2 randomization arms: active IFC and sham IFC (N.=36)
groups. - Declined to participate (N.=6)
- Other reasons (N.=3)
the physiatrist and the patients were blinded to the treat- dulum exercises (5 sets a day/5 minutes each set), cold
ment protocol throughout the study period (Figure 1). pack application (with cold pack gel, 4 times a day, 20
All patients provided written informed consent after minutes per session) on the affected shoulder, restric-
receiving a detailed information sheet describing the tion of daily activities that require the hands to be used
study protocol. The study protocol was approved by the over the head and sleeping on the affected shoulder, and
Fatih Sultan Mehmet Training and Research Hospital oral meloxicam 15 mg daily for two weeks.
Ethics Committee (approval number: 2015/10), and
was conducted in accordance with the Helsinki Decla- Outcomes and follow-up
ration of 1975, as revised in 2004. All participants were evaluated at pretreatment, immedi-
Randomization and interventions ately post-treatment, and 1 month post-treatment. Demo-
graphic data, the onset and duration of the complaints,
In this randomized, double-blind study, a researcher not hand dominance, Visual Analog Scale (VAS), Constant-
involved with data collection performed the randomiza- Murley Scale (CMS), and Shoulder Disability Question-
tion using random number generation in the software Mi- naire (SDQ) scores were recorded at the baseline assess-
crosoft Excel for Windows. The allocation was concealed ment. VAS, CMS, and SDQ scores which were the study’s
in sequentially numbered opaque sealed envelopes. After main independent variables, were re-recorded at the im-
the assessment, the eligible patients were randomly allo- mediately post-treatment and 1 month post-treatment as-
cated into the groups by the physiotherapist responsible sessments. VAS (score 0 means no pain, score of 10 mean
for the electrotherapy. the worst pain ever) was used to quantify the pain level
A pair of disposable electrodes (90x50 mm) were during rest, activity, and night periods.11
placed on the affected shoulder of the patient in the sit- CMS was used to assess the functional status of the
ting position in both groups. In active IFC group, bipolar affected shoulder. The CMS is a standardized clinical
IFC was applied 5 days a week, for a total of 10 sessions evaluation tool with a score ranging from 0 to 100 based
during 2 weeks, using the ITO EU-940 electrotherapy on evaluation of four parameters: pain (15 points), dai-
device. The medium frequency of the interferential cur- ly life activities (20 points), active ROM (40 points),
rent was 4000 Hz and 4100 Hz to produce the ampli- and muscle strength (25 points).12 The higher the CMS
tude-modulated frequency at 100 Hz.9 The physiothera- score, the better the functional status of the shoulder is.
pist increased the current amplitude until the participant Daily living activities were evaluated by SDQ. The
felt a strong but comfortable tingling. Every 5 minutes, SDQ is a pain-related disability questionnaire, which
the physiotherapist asked each participant whether the contains 16 items describing common situations that
“strong but comfortable tingling” remained. In case of may induce symptoms in patients with shoulder disor-
sensory habituation, the current amplitude was increased ders. All items refer to the preceding 24 hours. Response
until the participant reached the previous sensation.10 The options are either “yes,” “no,” or “not applicable”. The
duration of the stimulation was 20 minutes.6 ‘not applicable’ category should be used when the situ-
In the sham IFC group, IFC was applied in the same ation at issue has not occurred during the preceding 24
way with the light of the electrotherapy device switched hours. A final score is calculated by dividing the number
on but without any current. Participants were told that of items with a positive score by the total number of ap-
they would receive an electrical stimulation treatment plicable items and subsequently multiplying this num-
for pain relief and that they may or may not feel a very ber by 100. Final score ranges between 0 (no disability)
light tingling sensation in the shoulder during the elec- and 100 (all applicable items positive).13 The Turkish
trical stimulation. To indicate the end of the application, version of the SDQ was reported to be valid and reliable
the device made the same sound as the active current. by Ozsahin et al.14
The same physiotherapist with over 10 years of clinical Statistical analysis
or other proprietary information of the Publisher.
assuming α: 0.05, and power: 0.80. A sample size of 29 mediately and 1 month after treatment) was used to
subjects per group was determined and follow-up loss of evaluate the differences between groups with normal
10% were considered. For this calculation G*Power anal- distribution. Bonferroni adjustment was carried out for
ysis program was used. calculation of the time creating the difference. Friedman
Statistical analysis of data was performed by using Test was used for the comparison of the parameters with
IBM SPSS Statistics 22 (IBM SPSS, Turkey) program. non-normal distribution and Wilcoxon Sign Rank Test
Shapiro-Wilk Test was used to check whether the data was used for calculation of the time creating the differ-
is normally distributed. Besides descriptive statistical ence. Significance was evaluated at the level of P<0.05.
methods (mean, standard deviation, frequency), inter-
group comparisons were done by Student’s t-test and Results
Mann-Whitney U Test for the parameters with normal
and non-normal distribution, respectively. An analysis The study was conducted from December 2015 to June 2016.
of variance for repeated measures (pretreatment, im- A total of 110 patients were assessed and 65 were eligible and
Table II.—Comparison of resting, activity and night VAS Scores at baseline, post-treatment and 1 month post-treatment.
Sham IFC Active IFC
VAS 95% CI for the difference P
Mean (SD) Mean (SD)
Resting Baseline 2.53 (2.45) 2.87 (2.43) (-1.59, 0.93) 0.53
Post-treatment 1.10 (1.37) 1.07 (1.46) (-0.7, 0.77) 0.83
1 month 0.77 (1.25) 0.93 (1.44) (-0.86, 0.53) 0.63
p1 0.001 0.001
Activity Baseline 7.87 (1.76) 7.73 (1.82) (-0.79, 1.06) 0.76
Post-treatment 4.40 (2.16) 4.30 (1.73) (-0.91, 1.11) 0.91
1 month 3.47 (2.86) 3.90 (2.22) (-1.76, 0.89) 0.21
p1 0.001 0.001
Night Baseline 6.13 (3.31) 6.40 (3.05) (-1.91, 1.38) 0.83
or other proprietary information of the Publisher.
agreed to participate to the study. From 65 patients enrolled, IFC groups for disease-related variables of pain dura-
33 patients were randomized to the active IFC, 32 patients to tion, dominant hand, affected shoulder, and night pain
the sham IFC group. Three patients in the active IFC group (P>0.05). There were more women and upper extremity
and 2 patients in the sham IFC group withdrew during the user in the active IFC group. The characteristics of par-
follow-up period and the evaluations were done for the re- ticipants were presented in the Table I.
maining 60 patients (34 females and 26 males). A flow dia- Significant improvement in all parameters was ob-
gram of the patient allocation is presented in Figure 1. served on immediately post-treatment and 1 month
The mean age of the study patients was 50.02±9.10 post-treatment assessments compared to pretreatment
years. No significant difference was found between the assessments in both groups (P<0.01). Comparison of
active IFC (N.=30) and sham IFC (N.=30) groups for the VAS, CMS, and SDQ scores between the two groups
age, gender, Body Mass Index, upper extremity use in did not show any significant difference either before or
occupation, and education (P>0.05). Other than gender after treatment (P>0.05) (Table II-IV).
and upper extremity use in occupation, no significant All patients tolerated the treatments well and no ad-
difference was found between the active IFC and sham verse events were found related to the treatments.
Table III.—Comparison of Constant-Murley Scale and its subscale scores at baseline, post-treatment and 1 month post-treatment.
Sham IFC Active IFC
Constant Mean (SD) Mean (SD) 95% CI for the difference P
Table IV.—Comparison of Shoulder Disability Questionnaire scores at baseline, post-treatment and 1 month post-treatment.
Sham IFC Active IFC
SDQ 95% CI for the difference P
Mean (SD) Mean (SD)
Baseline 77.37 (17.35) 84.90 (14.45) (-15.78, 0.72) 0.07
or other proprietary information of the Publisher.
syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am 16. Radnovich R, Marriott TB. Utility of the heated lidocaine/tetracaine
1972;54:41-50. patch in the treatment of pain associated with shoulder impingement syn-
3. Yazmalar L, Sarıyıldız MA, Batmaz İ, Alpaycı M, Burkan YK, Özkan drome: a pilot study. Int J Gen Med 2013;6:641-6.
Y, et al. Efficiency of therapeutic ultrasound on pain, disability, anxiety, 17. Chang WK. Shoulder impingement syndrome. Phys Med Rehabil
depression, sleep and quality of life in patients with subacromial impinge- Clin N Am 2004;15:493-510.
ment syndrome: A randomized controlled study. J Back Musculoskelet 18. Watson T. The role of electrotherapy in contemporary physiotherapy
Rehabil 2016;29:801-7. practice. Man Ther 2000;5:132-41.
4. Pérez-Merino L, Casajuana MC, Bernal G, Faba J, Astilleros AE,
González R, et al. Evaluation of the effectiveness of three physiothera- 19. Van Der Heijden GJ, Leffers P, Wolters PJ, Verheijden JJ, van Mam-
peutic treatments for subacromial impingement syndrome: a randomised eren H, Houben JP, et al. No effect of bipolar interferential electrotherapy
clinical trial. Physiotherapy 2016;102:57-63. and pulsed ultrasound for soft tissue shoulder disorders: a randomised
controlled trial. Ann Rheum Dis 1999;58:530-40.
5. Koca I, Boyaci A, Tutoglu A, Ucar M, Kocaturk O. Assessment of the
effectiveness of interferential current therapy and TENS in the manage- 20. Cheing GL, So EM, Chao CY. Effectiveness of electroacupuncture
ment of carpal tunnel syndrome: a randomized controlled study. Rheuma- and interferential eloctrotherapy in the management of frozen shoulder. J
tol Int 2014;34:1639-45. Rehabil Med 2008;40:166-70.
6. Fuentes JP, Armijo Olivo S, Magee DJ, Gross DP. Effectiveness of In- 21. Page MJ, Green S, Mrocki MA, Surace SJ, Deitch J, McBain B, et
terferential Current Therapy in the Management of Musculoskeletal Pain: al. Electrotherapy modalities for rotator cuff disease. Cochrane Database
A Systematic Review and Meta-Analysis. Phys Ther 2010;90:1219-38. Syst Rev 2016;CD012225.
7. Caliş M, Akgün K, Birtane M, Karacan I, Caliş H, Tüzün F. Diagnostic 22. Voloshin I, Gelinas J, Maloney M, O’Keefe RJ, Bigliani LU, Blaine
values of clinical diagnostic tests in subacromial impingement syndrome. TA. Proinflammatory cytokines and metalloproteases are expressed in
Ann Rheum Dis 2000;59:44-7. the subacromial bursa in patients with rotator cuff disease. Arthroscopy
2005;21:1076.e1-1076.e9.
8. Cadogan A, McNair PJ, Laslett M, Hing WA. Diagnostic Accuracy of
Clinical Examination and Imaging Findings for Identifying Subacromial 23. Blaine TA, Kim YS, Voloshin I, Chen D, Murakami K, Chang SS, et
Pain. PLoS One 2016;11:e0167738. al. The molecular pathophysiology of subacromial bursitis in rotator cuff
9. Goats GC. Interferential current therapy. Br J Sports Med 1990;24:87-92. disease. J Shoulder Elbow Surg 2005;14(1 Suppl S):84S-89S.
10. Pantaleao MA, Laurino MF, Gallego NL, Cabral CM, Rakel B, Vance 24. Gotoh M, Hamada K, Yamakawa H, Inoue A, Fukuda H. Increased
C, et al. Adjusting pulse amplitude during transcutaneous electrical nerve substance P in subacromial bursa and shoulder pain in rotator cuff dis-
stimulation (TENS) application produces greater hypoalgesia. J Pain eases. J Orthop Res 1998;16:618-21.
2011;12:581-90. 25. Kim YS, Bigliani LU, Fujisawa M, Murakami K, Chang SS, Lee
11. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of vi- HJ, et al. Stromal cell-derived factor 1 (SDF-1, CXCL12) is increased in
sual analogue scales as ratio scale measures for chronic and experimental subacromial bursitis and downregulated by steroid and nonsteroidal anti-
pain. Pain 1983;17:45-56. inflammatory agents. J Orthop Res 2006;24:1756-64.
12. Constant CR, Murley AH. A clinical method of functional assessment 26. Okamura K, Kobayashi T, Yamamoto A, Shitara H, Osawa T, Ichi-
of the shoulder. Clin Orthop Relat Res 1987;214:160-4. nose T, et al. Shoulder pain and intra-articular interleukin-8 levels in pa-
tients with rotator cuff tears. Int J Rheum Dis 2017;20:177-81.
13. Van der Windt DA, Van der Heijden GJ, de Winter AF, Koes BW,
Deville W, Bouter LM. The responsiveness of the shoulder disability 27. Akkaya N, Akkaya S, Gungor HR, Yaşar G, Atalay NS, Sahin F.
questionnaire. Ann Rheum Dis1998;57:82-87. Effects of weighted and un-weighted pendulum exercises on ultrasono-
graphic Acromiohumeral distance in patients with subacromial impinge-
14. Ozsahın M, Akgun K, Aktas I, Kurtais Y. Adaptation of the shoulder
disability questionnaire to the Turkish population, its reliability and valid- ment syndrome. J Back Musculoskelet Rehabil 2017;30:221-8.
ity. Int J Rehabil Res 2008;31:241-5. 28. Gebremariam L, Hay EM, van der Sande R, Rinkel WD, Koes BW,
15. Galace de Freitas D, Marcondes FB, Monteiro RL, Rosa SG, Maria Huisstede BM. Subacromial impingement syndrome - effectiveness of
de Moraes Barros Fucs P, Fukuda TY. Pulsed electromagnetic field and physiotherapy and manual therapy. Br J Sports Med 2014;48:1202-8.
exercises in patients with shoulder impingement syndrome: a randomized, 29. Aktas I, Akgun K, Cakmak B. Therapeutic effect of pulsed electro-
double-blind, placebo-controlled clinical trial. Arch Phys Med Rehabil magnetic field in conservative treatment of subacromial impingement syn-
2014;95:345-52. drome. Clin Rheumatol 2007;26:1234-9.
Conflicts of interest.—The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.
Article first published online: September 11, 2017. - Manuscript accepted: September 5, 2017. - Manuscript revised: July 17, 2017. - Manuscript received:
March 20, 2017.
or other proprietary information of the Publisher.