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doi: 10.1093/pm/pny287
Advance Access Publication Date: 12 January 2019
Review Article
Correspondence to: Selaiman A. Noori, MD, Department of Pain Management, Anesthesiology Institute, Cleveland Clinic, 9500 Euclid Avenue,
C-25, Cleveland, OH 44195, USA. Tel: 216–445–9421; Fax: 216-444-9890; E-mail: selaiman.noori@gmail.com
Funding sources: The authors report no funding sources.
Abstract
Background. Low back pain (LBP) and neck pain are major causes of pain and disability that are experienced across
all ages. The primary goals of treatment are to improve patient function and facilitate a return to the patient’s desired
level of daily activity. Therapeutic ultrasound is a noninvasive modality widely utilized in the management of muscu-
loskeletal disorders, but there continues to be controversy regarding its use due to insufficient evidence of effective-
ness. The objective of this systematic review was to evaluate the effectiveness of therapeutic ultrasound in the man-
agement of patients with chronic LBP and neck pain. Methods. Using PRISMA guidelines, a search of the PubMed
and CENTRAL (The Cochrane Library) databases was performed to retrieve randomized controlled trials (RCTs) that
evaluated therapeutic ultrasound in patients with chronic LBP or neck pain. Results. The search strategy identified
10 trials that met the criteria for inclusion. Three studies in LBP reported that both therapeutic and sham (placebo) ul-
trasound provided significant improvement in pain intensity. In each of these studies, ultrasound was found to be
more effective than placebo when using only one of several validated instruments to measure pain. Three of the
four studies on neck pain demonstrated significant pain relief with ultrasound in combination with other treatment
modalities. However, only one of these studies demonstrated that the use of ultrasound was the cause of the statisti-
cally significant improvement in pain intensity. Conclusions. Therapeutic ultrasound is frequently used in the treat-
ment of LBP and neck pain and is often combined with other physiotherapeutic modalities. However, given the pau-
city of trials and conflicting results, we cannot recommend the use of monotherapeutic ultrasound for chronic LBP
or neck pain. It does seem that ultrasound may be considered as part of a physical modality treatment plan that may
be potentially helpful for short-term pain relief; however, it is undetermined which modality may be superior. In
both pain syndromes, further trials are needed to define the true effect of low-intensity ultrasound therapy for axial
back pain. No conclusive recommendations may be made for optimal settings or session duration.
Key Words: Therapeutic Ultrasound; Low Back Pain; Neck Pain; Axial Pain.
C 2019 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
V 1482
Therapeutic Ultrasound for Axial Spine Pain 1483
LBP and neck pain are both an enormous socioeconomic The Pain Conditions
problem and a major public health burden [3,4]. LBP is defined as pain in the lumbosacral region, typi-
The primary goals of treatment for LBP and neck cally between the lower margin of the 12th ribs and the
pain are to improve patient function and facilitate a return inferior gluteal folds, which may or may not have re-
to the patient’s desired level of daily activity. Although ferred pain to the lower limb(s) [1]. Neck pain is typically
different treatment modalities are used, many practice described as pain located in the anatomical posterior re-
guidelines recommend a biopsychosocial approach with gion of the neck from the superior nuchal line to the first
greater focus on self-management and psychological and thoracic spinous process, which may or may not radiate
physiotherapy, and less emphasis on medication use and to the upper limb(s) [2]. When LBP or neck pain persists
surgical intervention [5,6]. Therapeutic ultrasound is a for more than 12 weeks, it is considered chronic [1,8].
noninvasive modality commonly used in the management
of musculoskeletal disorders. It is utilized by 65% and 94%
Identification
Records excluded
(n=805)
Figure 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram for chronic low back pain.
Neck Pain Disability Scale five-point scale that is anchored by bipolar statements
The Neck Pain Disability Scale (NPDS) contains 20 items (0 ¼ no pain or full ability to function, 4 ¼ worst possible
related to four dimensions, including pain intensity, pain and/or unable to perform this function at all). The
neck problems, interferences with activities, and higher the total index score (range ¼ 0–100%), the higher
emotion/cognition. Each item is evaluated on a scale of the perceived dysfunction and pain [16].
0 (normal function) to 5 (worst possible situation), for a
maximum score of 100, indicating the worst pain and Pain Pressure Threshold
disability possible [14]. The pain pressue threshold (PT) is a valid and reliable
measure in which a pressure algometer (a metal rod at-
Short-Form 36 tached to a device that applies a discrete and variable
amount of force) is applied perpendicularly to the
The Short-Form 36 (SF-36) is a generic questionnaire for
patient’s skin. The pressure is gradually increased until
measuring health-related quality of life. It consists of
the patient reports a sensation of pain, at which point the
eight subscales and a total of 36 questions, with lower
value on the algometer is recorded [17].
scores corresponding to poorer health (range ¼ 0–100).
The eight dimensions include physical function, role limi-
tation due to a physical problem, bodily pain, general Strength of Evidence
health perceptions, vitality, social functioning, role limi-
Guidelines from the Oxford Centre for Evidence-Based
tation due to emotional problem, and mental health [15].
Medicine (CEBM) Levels of Evidence (March 2009)
were utilized to determine the strength of evidence for in-
Functional Rating Index cluded RCTs [18].
The Functional Rating Index (FRI) is a valid instrument
for quantifying pain and function of the spinal musculo-
skeletal system, including the cervical and lumbar regions.
Results
It consists of 10 items, including pain intensity, personal Low Back Pain
care, lifting, sleeping, social life, traveling, walking, stand- The search strategy identified six trials that met the crite-
ing, work, and frequency of pain. Each item is ranked on a ria for inclusion (Figure 1), and 43 full-text articles were
Table 1. Characteristics and results of included studies for chronic low back pain
(continued)
1485
(continued)
Noori et al.
CI ¼ confidence interval; ES ¼ electrical stimulation; FRI ¼ Functional Rating Index; ODI ¼ Oswestry Disability Index; PP ¼ phonophoresis; SF-36 ¼ Short-Form 36; US ¼ ultrasound; VAS ¼ visual analog scale.
1487
Identification
Records excluded
(n=487)
Figure 2. Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram for chronic neck pain.
excluded (Supplementary Data). The characteristics and The study samples ranged from 26 to 102 participants
results of these six studies are shown in Table 1. The in- and had treatment durations of three to six weeks.
cluded studies had sample sizes ranging from 10 to 112
participants and treatment durations of three to six
weeks. Most studies included blinded patients and/or Discussion
outcome assessors blinded to treatment allocation; how-
Although therapeutic ultrasound is not regarded as
ever, no study blinded the care providers. Across all stud-
firstline treatment for nonspecific LBP and neck pain, it
ies, therapeutic ultrasound consisted of a 1-MHz
is often used—especially combined with physiotherapy
frequency in continuous mode, ranging in intensity from
or exercise [7,25]. The aim of our study was to determine
1 W/cm2 to 2.5 W/cm2 and in effective radiating area
the effectiveness of therapeutic ultrasound in pain reduc-
(ERA) from 4 cm2 to 5 cm2.
tion for patients with nonspecific chronic LBP or neck
Three studies blinded patients to group allocation by
pain.
utilizing sham ultrasound [19,21,23]. Three studies
(N ¼ 102) reported that both therapeutic and sham (pla-
cebo) ultrasound provided significant improvement in Low Back Pain
pain intensity [19,21,23]. In each of these studies, thera- Six small randomized controlled trials (333 participants)
peutic ultrasound was found to be more effective than evaluating ultrasound therapy for chronic LBP were in-
placebo in only one of several validated instruments (e.g., cluded in this systematic review. The majority of RCTs
VAS, FRI) used to measure pain. No study reported ad- that did not meet inclusion criteria utilized ultrasound as
verse events or assessed cost-effectiveness. part of a treatment package; therefore, it was not possible
to isolate the effectiveness of ultrasound alone. Three
studies (N ¼ 102) reported that therapeutic ultrasound
Neck Pain was more effective than placebo in only one of several
The search strategy identified five trials that met the cri- scales used to measure pain.
teria for inclusion (Figure 2), and five full-text articles The included studies indicate that there is a lack of
were excluded (Supplementary Data). The characteristics strong evidence that therapeutic ultrasound significantly
and results of these five studies are shown in Table 2. improves pain scores in patients with nonspecific chronic
Table 2. Characteristics and results of included studies for chronic neck pain.
Study Level of
Study Duration No. Intervention Controls Follow-up Scale Results Outcome and Results Evidence
Esenyel, 2000 [25] 10 sessions 102 US, continuous 1. TP injections 2 weeks after and VAS, PT VAS before, 2 weeks after, and Compared with the con- Ib
(Turkey) Exercise Exercise 3 months after 3 months after treatment, trol group, the thera-
2. Exercise only treatment (0–10 cm), mean 6 SD peutic US and TP
completion US: 7.24 6 1.62, 3.04 6 1.78, injection groups exhib-
3.08 6 2.42 ited a statistically sig-
TP: 7.16 6 1.66, 3.05 6 1.72, nificant improvement
3.19 6 2.51 in VAS pain score and
Stretching: 6.50 6 0.93, 6.46 PT (P < 0.001)
6 0.93, 5.78 6 0.87 (P <
0.379)
PT before, 2 weeks after, and
3 months after treatment,
Therapeutic Ultrasound for Axial Spine Pain
mean 6 SD, kg
US: 3.12 6 0.52, 4.24 6 0.62,
4.19 6 0.61
TP: 3.06 6 0.48, 4.28 6 0.57,
4.15 6 0.53
Stretching: 3.31 6 0.33, 3.33
6 0.32, 3.92 6 0.29
(P<0.517)
Lee, 1997 [26] Unspecified 26 US 1 MHz, 1. Sham US None VAS, PT Percent change in VAS, mean US alone and combined IIb
(USA) continuous 2. TENS 6 SD with TENS did not sig-
3. US þ TENS US: –0.31 6 0.37 nificantly improve pain
Sham US: –0.17 6 0.39 or pain threshold
TENS: –0.52 6 0.38, P < 0.05
US þ TENS: –0.32 6 0.35
Percent change in PT, mean 6
SD
US: 0.10 6 0.49
Sham US: 0.00 6 0.25
TENS: –0.02 6 0.24
US þ TENS: –0.02 6 0.18
Matijevic-Mikelic, 5 sessions a 100 US, continuous Sham US 1 month after VAS at rest, VAS Differences in VAS (in mm) at Both groups demon- Ib
2012 [27] week for 3 Exercise Exercise treatment during rest between the study and strated significantly less
(Croatia) weeks TENS TENS completion movement control groups, Mann- pain with treatment,
Whitney U test, Z score, but there was no statis-
P value tically significant dif-
Before treatment: 1,113, –0.97, ference in VAS scores
P > 0.01 between the study and
After 15 sessions: 1,215, –0.25, control groups at the
P > 0.01 end of treatment and 1
1 month post-treatment: 1,176, month post-treatment
–0.55, P > 0.01
1489
(continued)
Study Level of
Study Duration No. Intervention Controls Follow-up Scale Results Outcome and Results Evidence
Differences in VAS (0–100
mm) during movement be-
tween the study and control
groups, Mann-Whitney U
test, Z score, P value
Before treatment: 893, –2.52,
P < 0.05
After 15 sessions: 979, –1.88,
P > 0.01
1 month post-treatment: 1,224,
–0.19, P > 0.01
Ustun, 2014 [14] 15 sessions, 50 US, continuous Phonophoresis None VAS at rest, VAS Difference between groups PH group had statistically Ib
(Turkey) duration of with 1 tube of during move- after treatment completion, significantly greater de-
study EMLA cream ment, NPDS mean 6 SD crease in pain intensity
unspecified (750 mg lido- VAS (0–100 mm) at rest: 1.66 at rest and NPDI
caine þ 750 mg 6 3.09, P ¼ 0.010 scores; no significant
prilocaine) VAS (0–100 mm) on move- difference in pain in-
ment: 0.36 6 2.89, tensity on movement;
P ¼ 0.476 no side effects observed
NPDS: 3.44 6 22.55, in either group
P ¼ 0.428
Dibai-Filho, 2017 10 sessions, 60 US 1 MHz, 1. Manual 1 month after NRS, NDI, PRSS NRS at rest before, after Analyzing the outcomes Ib
[28] twice a continuous therapy treatment 1 session, after 10 sessions, of all 3 groups over
(Brazil) week for 5 Manual therapy 2. Manual completion 1 month after last session time demonstrates sim-
weeks therapy þ (0–10), mean 6 SD ilar results: signifi-
diadynamic US þ manual therapy: 3.40 6 cantly reduced pain
currents 2.21, 3.35 6 2.23, 1.30 6 intensity and disability;
1.83, 1.75 6 1.68 all groups also demon-
Manual therapy: 3.50 6 1.47, strated similar
3.30 6 1.62, 1.90 6 1.77, increases in pressure
2.20 6 2.28 pain threshold
Manual therapy þ diadynamic:
3.00 6 2.02, 2.55 6 1.73,
1.55 6 0.99, 1.00 6 0.85
NDI before, after 1 session, af-
ter 10 sessions, 1 month after
last session (0–50), mean 6
SD
US þ manual therapy: 11.90 6
4.11, 9.55 6 5.27, 7.15 6
5.26, 7.80 6 5.40
Manual therapy: 12.20 6 4.14,
10.70 6 3.43, 7.45 6 3.80,
8.85 6 4.98
Noori et al.
(continued)
Evidence
CLBP ¼ chronic low back pain; CNP ¼ chronic neck pain; ERA ¼ effective radiating area; ES ¼ electrical stimulation; FRI ¼ Functional Rating Index; NDI ¼ Neck Disability Index; NPDS ¼ Neck Pain Disability Scale;
NRS ¼ numeric rating scale; ODI ¼ Oswestry Disability Index; PP ¼ phonophoresis; PRSS ¼ Pain-Related Self-Statement Scale; PT ¼ pain threshold; SF-36 ¼ Short-Form 36; TENS ¼ transcutaneous electrical nerve stimulation;
Level of at the end of treatment in one of several pain scales when
therapeutic ultrasound was compared with placebo or
exercise only. All trials included in the present study were
single-blinded and had small sample sizes, and most stud-
Outcome and Results
[29].
0.58 6 0.75
Neck Pain
Results
Recommendations
Given the paucity of trials and conflicting results, we can-
Duration
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Appendix