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Physiotherapy Theory and Practice

An International Journal of Physical Therapy

ISSN: 0959-3985 (Print) 1532-5040 (Online) Journal homepage: http://www.tandfonline.com/loi/iptp20

The effectiveness of low-level laser therapy


on pain, self-reported hand function, and
grip strength compared to placebo or “sham”
treatment for adults with carpal tunnel syndrome:
A systematic review

Marlette Burger, Réna Kriel, Andrea Damon, Amy Abel, Anisha Bansda,
Marinique Wakens & Dawn Ernstzen

To cite this article: Marlette Burger, Réna Kriel, Andrea Damon, Amy Abel, Anisha Bansda,
Marinique Wakens & Dawn Ernstzen (2017): The effectiveness of low-level laser therapy on
pain, self-reported hand function, and grip strength compared to placebo or “sham” treatment for
adults with carpal tunnel syndrome: A systematic review, Physiotherapy Theory and Practice, DOI:
10.1080/09593985.2017.1282999

To link to this article: http://dx.doi.org/10.1080/09593985.2017.1282999

Published online: 08 Mar 2017.

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Download by: [FU Berlin] Date: 09 March 2017, At: 00:59


PHYSIOTHERAPY THEORY AND PRACTICE
http://dx.doi.org/10.1080/09593985.2017.1282999

RESEARCH REPORT

The effectiveness of low-level laser therapy on pain, self-reported hand function,


and grip strength compared to placebo or “sham” treatment for adults with
carpal tunnel syndrome: A systematic review
Marlette Burgera, Réna Kriela, Andrea Damonb, Amy Abelc, Anisha Bansdad, Marinique Wakense,
and Dawn Ernstzena
a
Division of Physiotherapy, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; bPhillo Beukes
Physiotherapy, Hunters Medical Services, Knysna, South Africa; cDepartment of Physiotherapy, Jacquie Kieck Physiotherapy, Port Alfred,
South Africa; dLinksfield Netcare Hospital and New Life Kensington Hospital, Johannesburg, South Africa; eDepartment of Physiotherapy, Prof
ZK Matthews Hospital, Barkly West, South Africa

ABSTRACT ARTICLE HISTORY


Background: Carpal tunnel syndrome (CTS) is one of the most common peripheral neuropathies Received 5 June 2015
in the upper extremity. Objective: The aim of this review was to systematically and critically Revised 20 January 2016
appraise the available literature for the effectiveness of Low-Level Laser Therapy (LLLT) on pain, Accepted 31 January 2016
self-reported hand function, and grip strength compared to placebo treatment in adults with CTS. KEYWORDS
Methodology: Seven databases were searched from 2000 to March 2015 namely: Cinahl, Low level laser therapy;
Cochrane Library, EBSCOhost, PEDro, PubMed, Science Direct, and Scopus. Key search terms were: carpal tunnel syndrome;
CTS, LLLT, and physiotherapy. Specific inclusion and exclusion criteria were applied. The metho- physiotherapy or physical
dological quality was appraised with the PEDro scale. Data were extracted and captured on an therapy; systematic review
Excel spreadsheet. Results: The nine included randomized control trials (RCTs) had an average
score of 8.2/11 according to the PEDro scale. The heterogeneity of the LLLT regimes used made
statistical pooling inappropriate for this review and results were described narratively.
Conclusion: No strong evidence exists concerning the effects of LLLT on CTS in adults. Studies
that used 780–860 nm Lasers and energy dosages of 9–11 J/cm2 or 10.8 J reported a more
favorable outcome for pain, symptom severity, and functional ability as well as grip strength at
the end of treatment and short-term follow up.

Introduction tunnel, by means of carpal tunnel release (Scholten et al,


2007). The indications for surgery include severe CTS and
Carpal Tunnel Syndrome (CTS) is the most common of
the failure to respond to conservative treatment (Scholten
all entrapment neuropathies and is caused by the com-
et al, 2007). Conservative treatment is generally consid-
pression of the median nerve in the carpal tunnel
ered a first option in treating mild to moderate cases of
(Tascioglu, Degirmenci, Ozkan, and Mehmetoglu,
CTS (Scholten et al, 2007). Conservative management for
2012). The elevated pressure on the median nerve
CTS includes wrist splinting, oral steroids, corticosteroid
leads to symptoms and signs of nerve dysfunction and
injections, ultrasound therapy, and low-level laser therapy
impaired nerve conduction (Werner and Andary,
(LLLT) (Gerritsen et al, 2002). Clinical and neurophysio-
2002). The typical symptoms of CTS include pain,
logic outcome measures used to determine the efficacy of
tingling, and numbness in the sensory distribution of
therapy include patient’s pain and symptom severity
the median nerve path (Abid Ali, Ja’afar, and Hasan,
scales, functional status scales, objective grip strength
2012) and muscle weakness or atrophy of the muscles
measurement by means of a dynamometer, sensory and
in the hand innervated by the median nerve (Moore,
motor nerve conduction measurements and ultrasono-
Dalley, and Agur, 2010). CTS is associated with repeti-
graphical assessments (Abid Ali, Ja’afar, and Hasan,
tive strain injuries, inflammatory, or metabolic diseases
2012; Tascioglu, Degirmenci, Ozkan, and Mehmetoglu,
and pregnancy (Evcik et al, 2007).
2012).
Management for CTS entails a wide range of options,
LLLT is a conservative management option for
both conservative and surgical. Evidence supports the
CTS, commonly used by physiotherapists (Herpich
effectiveness of surgical decompression of the carpal
et al, 2015), yet its effectiveness for CTS has not yet

CONTACT Marlette Burger mbu@sun.ac.za Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town 8000, South Africa

© 2017 Taylor & Francis


2 M. BURGER ET AL.

been confirmed. LLLT has been used to stimulate decisions regarding the inclusion of articles were
wound healing by increasing collagen synthesis and based on agreement among the seven investigators.
is effective in reducing edema formation and inflam-
matory in animal studies (Albertini et al, 2007;
Study inclusion and exclusion criteria
Medrado, Pugliese, Reis, and Andrade, 2003).
LLLT’s physiological effect on altering the function Type of study
or stimulating the regeneration of peripheral nerves is Only RCTs published in English from January 2000
still unclear (Irvine, Chong, Amirjani, and Ming until March 2015 were eligible for inclusion in this
Chan, 2004; Tascioglu, Degirmenci, Ozkan, and review. According to the National Health and Medical
Mehmetoglu, 2012). LLLT was found to be effective Research Council (NHMRC) Hierarchy of evidence
in treating CTS by reducing pain, improving self- (Merlin, Weston, and Tooher, 2009), a well conducted
reported hand functionality, and improved motor RCT, as level II evidence, is appropriate for the purpose
and sensory nerve conduction in four randomized of answering an intervention question in a systematic
control trials (RCTs) (Abid Ali, Ja’afar, and Hasan, review. Levels III-2, 3, and IV are progressively less
2012; Chang, Jiang, Yeh, and Tsai, 2008; Jiang et al, reliable in answering an intervention effectiveness ques-
2011; Shooshtari et al, 2008). However, these findings tion. The quality of the RCTs was used as an additional
were contradicted by Tascioglu, Degirmenci, Ozkan, criterion. Therefore, RCTs with a low methodological
and Mehmetoglu (2012) and Irvine, Chong, Amirjani, score (below 4/11 on the PEDro scale) were excluded
and Ming Chan (2004), who found that LLLT was not from the final review.
more effective than placebo laser. Evcik et al. (2007)
reported that LLLT was effective for improving grip Type of patients
strength. In order to optimize the quality of care for Study patients could include adults (> 18 years), male
patients with CTS, a critical review of the body of and/or females with a clinical diagnosis of CTS. RCTs
evidence regarding the effectiveness of LLLT is including patients with CTS caused by traumatic injury
needed to support the development of evidence- were excluded. The types of interventions had to
based treatment protocols and clinical guidelines. include LLLT compared to placebo or “sham” therapy.
The primary objective of this systematic review was Studies that included additional interventions were
thus to review the available evidence on the effective- considered if both the experimental and control groups
ness of LLLT compared to placebo or “sham” treatment received the interventions. Examples of such additional
in the management of adults with CTS with regard to interventions include: night splinting, patient educa-
pain, hand function, and grip strength. The secondary tion, home and work advice on activities and risk
objective of this systematic review was to determine the factors for CTS. RCTs including surgical carpal tunnel
optimal treatment techniques and dosages (intensity release or corticosteroid injections or other electrother-
and duration) for LLLT in treating adults with CTS. apy modalities (e.g. ultrasound) as part of their inter-
vention were excluded. The comparator to LLLT could
include placebo or “sham” treatment.
Methodology
Type of outcomes
Search strategy
RCTs had to assess at least one the following four
A total of seven electronic databases, available through clinical outcomes, namely pain, symptom severity,
the (Stellenbosch) University Library, were searched, hand function, and grip strength. The outcome mea-
namely CINAHL, Cochrane Library, EBSCOhost, sures that studies could utilize included, but were not
PEDro, PubMed, Science Direct, and Scopus. The key confined to: Visual Analog Scale (VAS) (Gallagher,
search terms used were: carpal tunnel syndrome, laser Liebman, and Bijur, 2001) or any other validated scale
AND/OR low level laser, physical therapy AND/OR for measurement of pain intensity, self-reported symp-
physiotherapy. Each database was searched indepen- tom and function questionnaire/s, isometric pinch
dently by two investigators. Based on the inclusion strength and hand grip strength measured by a
and exclusion criteria below, five investigators indepen- dynamometer.
dently reviewed the titles, abstracts, and full text articles
retrieved in the initial search. The researchers com-
Methodological appraisal
pared the eligible articles selected for inclusion and
disagreements for accepting full-text articles were dis- The PEDro scale was used to determine the methodo-
cussed until consensus was achieved. The final logical quality and potential sources of bias of the
PHYSIOTHERAPY THEORY AND PRACTICE 3

included studies. The PEDro scale is a valid measure of number of patients and ages), type of intervention,
the methodological quality of clinical trials and is comparisons, outcome measures (including measure-
widely used in physiotherapy research (De Morton, ment tool, validity, and reliability), dichotomous data
2009). The scale consists of eleven criteria of which (intervention and comparison group), continuous data
criteria 1–8 measure the internal validity, criteria 9–10 (intervention and comparison group), clinical status,
measure the statistical reporting score and criterion 11 and implication.
measures the external validity. The eligible articles were Due to the heterogeneity of the intervention used
scored independently by two investigators. If a discre- (different types of lasers and dose regimens) in the
pancy in final scores existed, the rest of the research included studies, statistical pooling of data was not
group was consulted to reach consensus. appropriate for this review. Results were subsequently
summarized in the narrative form.
Data extraction and analysis method
The data were extracted and captured on a Microsoft Results
Excel spreadsheet by one investigator to ensure conti-
Selection of articles
nuity. The information was cross-checked by the rest of
the team. All data were tabulated into the following The results of the search strategy are presented in a
categories: citation, type of study, patients (including flow chart (Figure 1). A total of 487 initial titles were

Accepted titles or Duplicates among


Database / other sources Initial hits
abstracts databases
CINAHL 29 1
IDENTIFICATION

Cochrane library 38 5
Ebsco Host 17 5
PEDro 30 6
Pubmed 103 7 21
Science Direct 106 2
Scopus 164 4
Hand searches N/A 1
Total of records identified 487 31
SCREENING

Excluded titles and abstracts (Articles were excluded due


to irrelevant titles and animal studies) n = 456

Included titles and abstracts


n = 31

Excluded duplicate titles


ELIGIBILITY

n = 21

Full text eligible articles retrieved


n = 10

Excluded full text articles not meeting inclusion


criteria
n=1
Reason: comparison did not include sham LLLLT
INCLUDED

Studies included
n=9

Figure 1. Results of database searches.


4 M. BURGER ET AL.

found. Of these, 31 abstracts were reviewed and after duration of 15 seconds and Evcik et al. (2007) and
eliminating duplicates, nine full-text articles were sub- Shooshtari et al. (2008) did not specify their treatment
sequently considered eligible for use in this systematic duration. Chang, Jiang, Yeh, and Tsai (2008) and Jiang
review. et al. (2011) used the exact same laser type and settings.
The other seven studies all used different settings as
indicated in Table 2. Abid Ali, Ja’afar, and Hasan
Evidence hierarchy and methodological appraisal
(2012) did not indicate the energy dosage (J/cm2) that
A total of nine articles were included: 1) Abid Ali, they have applied. The studies applied the LLLT over
Ja’afar, and Hasan, 2012; 2) Chang, Jiang, Yeh, and the carpal tunnel area and/or followed the median
Tsai, 2008; 3) Evcik et al, 2007; 4) Fusakul, nerve path (Table 2).
Aranyavalai, Saensri, and Thiengwittayaporn, 2014; 5) All control groups in the articles reviewed, received
Irvine, Chong, Amirjani, and Ming Chan (2004); 6) sham laser treatment over the matching areas as the
Jiang et al, 2011; 7) Lazovic et al, 2014; 8) Shooshtari intervention groups. Evcik et al. (2007) also reported
et al, 2008; and 9) Tascioglu, Degirmenci, Ozkan, and that night splints were used for two weeks by the
Mehmetoglu, 2012. All nine articles were classified as intervention and placebo laser groups, while Fusakul,
Level II according to the NHMRC Hierarchy of Aranyavalai, Saensri, and Thiengwittayaporn (2014)
Evidence. The methodological quality of the nine encouraged intervention and placebo laser groups to
included articles, according to the PEDro scale, ranged use neutral wrist splints for 12 weeks during the night
between 6/10 and 10/10, with an average score of 8.2/10 as well as during the daytime.
Table 1).

Description of studies Description of outcome measures


As indicated by Table 1, the included studies compared All studies measured and reported outcomes at base-
LLLT with a placebo and/or with a control group. line. The studies had different re-assessment intervals
Tascioglu, Degirmenci, Ozkan, and Mehmetoglu for the outcomes, ranging from 2 weeks to 12 weeks.
(2012) and Jiang et al. (2011) both had two intervention Evcik et al. (2007) and Fusakul, Aranyavalai, Saensri,
groups. Tascioglu, Degirmenci, Ozkan, and and Thiengwittayaporn (2014) retested at 12 weeks and
Mehmetoglu (2012) administered a different energy were the only studies to report on long-term outcome
dosage in the A and B laser groups. Jiang et al. (2011) (10 weeks and seven weeks respectively after the end of
subdivided the patients into either mild or moderate the last treatment session). Evcik et al. (2007) only
CTS. The mean ages between intervention and control retested grip strength at 4 weeks (2 weeks after the
groups were comparable and ranged between 43 and end of the treatment period). Shoostari et al. (2008)
52.6 years. The female to male ratio’s differed for all and Tascioglu, Degirmenci, Ozkan, and Mehmetoglu
articles; more females than males participated. Chang, (2012) re-assessed at the end of the treatment period
Jiang, Yeh, and Tsai (2008) and Jiang et al. (2011) did (at 3 weeks), but did not conduct a follow-up
not specify the patients’ gender. The total sample for assessment.
the LLLT and control groups captured in the nine The outcome measures used in the nine articles of
studies was 614. this review are categorized into four main groups: 1)
Pain; 2) Symptom Severity Score; 3) Self-reported Hand
Function; and 4) Grip Strength. Pain, using the VAS,
Description of intervention
was measured in all studies except Irvine, Chong,
Table 2 summarizes the laser settings, dosages and Amirjani, and Ming Chan (2004). The Levine question-
treatment intervals that were used for the different naire was most commonly used to test symptom sever-
trials. The number of treatment sessions ranged ity and functional status (Chang, Jiang, Yeh, and Tsai,
between 10 to 20 sessions. Except for Irvine, Chong, 2008; Evcik et al, 2007; Irvine, Chong, Amirjani, and
Amirjani, and Ming Chan (2004) and Fusakul, Ming Chan, 2004; Tascioglu, Degirmenci, Ozkan, and
Aranyavalai, Saensri, and Thiengwittayaporn (2014) Mehmetoglu, 2012). Jiang et al. (2011) and Fusakul,
who had 3 weekly sessions for 5 weeks, all other studies Aranyavalai, Saensri, and Thiengwittayaporn (2014)
used once daily sessions five times per week for either 2 used the Boston Questionnaire to assess symptom
or 3 weeks. The duration of treatment ranged from 10 severity and functional status. Abid Ali, Ja’afar, and
to 15 minutes per session. Irvine, Chong, Amirjani, and Hasan (2012) did not specify the questionnaire used
Ming Chan (2012) used a much shorter treatment while Shooshtari et al. (2008) and Lazovic et al. (2014)
Table 1. Study sample description.
Shooshtari et al Tascioglu et al Fusakul et al Lazovic et al
Irvine et al (2004) Evcik et al (2007) Chang et al (2008) (2008) Jiang et al (2011) Abid Ali et al (2012) (2012) (2014) (2014)
Inclusion Criteria Numbness & CTS diagnosis by Diagnosed with CTS
Electro diagnostic Idiopathic CTS Idiopathic CTS CTS diagnoses CTS diagnosis by CTS diagnosis by
tingling in Median clinical First onset of CTS
evidence of diagnoses. diagnoses confirmed with clinical clinical
Nerve distribution. examination and more than a year prior
Median Nerve Nerve conduction sensory and examination and examination (pain,
Nocturnal electromyography to the start of the
compression studies. motor Median electro paraesthesia,
symptoms study with repeated
Paraesthesia and nerve diagnosis. numbness,
Weakness of thumb episodes numbness conduction tingling, + Tinel’s
abduction. Excessive hand studies sign)
Electrophysiological sweating or Electromyography
evidence of Median coldness + Tinel’s and Median Nerve
Nerve compression sign or Phalen test Conduction
Nocturnal studies
symptoms
Exclusion Criteria Evidence of axonal Trauma to wrist/ Previous wrist surgery Trauma to wrist/ Rheumatoid arthritis Did not specify CTS symptoms Metabolic Did not specify
loss. Arthritis arm Cervical Previous laser arm or neck Metabolic disorders longer than 6 disorders
Trauma to wrist/arm radiculopathy treatment for CTS Metabolic Previous wrist surgery months
Previous Carpal Thoracic Outlet Rheumatoid Arthritis disorders Other concurrent Previous wrist Pregnancy
tunnel release Syndrome Metabolic disorders Pregnancy treatments e.g. anti- surgery
Neurologic, Paralysis due to stroke Previous carpal inflammatory Carpal bone Previous distal
cognitive, tunnel release medication, physical fractures radial fracture.
inflammatory and Carpal bone therapy, acupuncture Proximal Wrist/hand
tumoral disorders fractures Median deformities
neuropathy Inflammation
of wrist
Cervical Rheumatoid
Radiculopathy Arthritis
Polyneuropathy Cervical
Radiculopathy
Brachial Polyneuropathy
plexopathy,
Thoracic Outlet Proximal
Syndrome Median
neuropathy
Rheumatoid Ulnar
Arthritis neuropathy
Metabolic Carpal tunnel
disorders release
Pregnancy
Acromegaly
Physical
Therapy prior
to study.
Participants LLLT n=7 n = 41, 72 wrists n = 20 n = 40 n(mild) = 27 n = 30 n(A) = 20 n = 56 wrists N = 40, 61 wrists
n(mod) = 18 n(B) = 20
Placebo n = 8 n = 40, 69 wrists n = 20 n = 40 n(mild) = 27 n = 30 n = 20 n = 56 wrists N = 39, 59 wrists
n(mod) = 15
Control n = 30
PHYSIOTHERAPY THEORY AND PRACTICE

(Continued )
5
6
M. BURGER ET AL.

Table 1. (Continued).
Shooshtari et al Tascioglu et al Fusakul et al Lazovic et al
Irvine et al (2004) Evcik et al (2007) Chang et al (2008) (2008) Jiang et al (2011) Abid Ali et al (2012) (2012) (2014) (2014)
Age of LLLT 43 ± 4 47.7 ± 10.0 (28– 46.01 ± 11.65 48.12 ± 10.73 (30– (mild) 46.44 ± 10.12 45 ± 5.6 (A) 47.25 ± 50.7 ±1.39 50.5 ± 10.1
Participants 75) 70) 7.35
[mean ± SD (mod) 48.76 ± 14.57 (B) 45.80 ±
(age range)] 8.61
Placebo 50 ± 4 51.0 ± 11.8 (26– 49.07 ± 11.28 (mild) 51.10 ± 12.19 50.90 ± 9.11 50.79 ± 1.38 52.6 ± 11.6
76) (mod) 44.60 ± 9.60
Control 73/7 43.7 ± 3.7
Gender (F/M) LLLT 6/1 33/8 33/27 (A) 17/13 54/2 36/4
(B) 14/6
Placebo 6/2 37/3 15/5 54/2 34/5
PEDro Scores 10/10 8/10 8/10 6/10 8/10 7/10 8/10 9/10 10/10
Statistical significant No significant No significant Laser group showed Did not provide Laser group showed a Laser group showed No significant Laser group Laser group
main findings for Pain, difference in any of difference in any significant reduction in between group significant reduction in significant reduction in difference in showed a showed a
SSS, FSS, Grip Strength as the outcome of the outcome Pain, FSS, SSS, Hand statistical analysis Pain compared to Pain, FSS and SSS any of the significant significant
reported by the authors measures between measures Grip Strength and for the Laser and placebo group at end of compared to Placebo outcome reduction in the reduction in Pain
the Laser and the between the Pinch Grip Strength Placebo groups. treatment, but only the group at end of measures SSS compared to compared to
Placebo groups. Laser and the compared to Placebo mild group showed a treatment and at between the Placebo group at Placebo group at 8
Placebo groups. group at follow-up. significant reduction in follow up. Laser and the end of weeks follow up.
pain at follow up. Only Placebo treatment.
the mild CTS patients in groups.
the Laser group showed
significant reduction in
SSS compared to
Placebo group at end of
treatment.
Country of Origin Canada Turkey Taiwan Iran Taiwan Baghdad Turkey Thailand Serbia
SSS = Symptom Severity Scale; FSS = Functional Status Score; LLLT = Low-level laser therapy
Table 2. Treatment specifications.
Irvine et al Shooshtari Abid Ali et al Tascioglu et al (2012) Lazovic et al
(2004) Evcik et al (2007) Chang et al (2008) et al (2008) Jiang et al (2011) (2012) A B Fusakul et al (2014) (2014)
Energy dosage 6J/cm2 14J (7J/point) 9.7J/cm2 9–11J/cm2 9.7J/cm2 6J (3 J/ 3J (1.5 J/ 18J 10.8 J; 13.6 J/cm2
point) point)
Laser type Eriel TOP 250 GaAlAs PL-830 PL-830 Galium-Arsenide GaAlAs GaAlAs GaAlAs GaAlAs
GaAlAs
Wavelength (nm) 860 830 830 785 830 904 830 830 810 780
Power output (mW) 60 450 60(2x30) 400 60(2x30) 15 50 50 50 30
Laser probe diameter 1cm beam = beam =
1mm 1mm
Beam Single Single Double Single Double Single Single Single Single
Mode pulsed pulsed pulsed continuous continuous continuous continuous
Frequency (Hz) 1000 10 4672 & 10 5000
1168
Points 20 2 15 5 5 4
Sessions 15 10 10 15 10 10 15 15 15 20
Time per session (min) 15 sec 10 10 15 10 5 360sec 360sec
Accumulated dosage 140J 90J 45J 270J 216J
Frequency of 5 (3 times per 2 (5 times per 2 (5 times per week) 3 (5 times 2 (5 times per week) 2 (5 times per 3 (5 times 3 (5 times 5 (3 times per week)5 (5x/week for 2
intervention per week) week) per week) week) per week) per week) weeks; 3x/week
week for 3 weeks)
Treatment location/ A total of 20 Over the carpal Directly over the Over the Palm side of wrist Directly along Across the Across the Across the median Directly on the
area sites over and tunnel area at the transverse carpal carpal between pisiform and median nerve median median nerve path over the skin, at four
surrounding wrist - directly and ligament. Did not tunnel area navicular bones. Did path over the nerve path nerve path wrist. 10 cm away points
the carpal perpendicularly on follow the median at the not follow the median transverse carpal over the over the from the skin parallel perpendicularly
tunnel. the skin. nerve path. wrist. nerve path. ligament. wrist. wrist. to the distal crease of over the carpal
the wrist (5 cm below tunnel area.
and above the distal
crease) over the
median nerve.
*Grey blocks indicate missing information
PHYSIOTHERAPY THEORY AND PRACTICE
7
8 M. BURGER ET AL.

Table 3. Mean change from baseline and P-values for Pain.


Pain
12wks F/U Mean
Baseline EOT Mean change EOT within F/U Mean change change from 12wks F/U
mean on from baseline on same group from baseline on F/U P baseline on VAS within same
VAS (mm) VAS (mm) P Value VAS (mm) Value (mm) group P value
Shooshtari LLLT 78.0 −28.2 p < 0.001
et al Placebo 80.1 −3.9 p < 0.001
(2008)
Jiang et al Mild LLLT 50.7 −27.6
(2011) Placebo 51.6 -0.5
LLLT p < 0.001
versus
Placebo
Mode-rate LLLT 79.1 −31.7
Placebo 71.0 −20.1
LLLT p < 0.01
versus
Placebo
Abid Ali et LLLT 71.0 −45.5 p < 0.01 −50.4 p < 0.01
al (2012) Placebo 58.3 +5.3 p = 0.08 +18.7 p = 0.05
LLLT versus Placebo p < 0.001 p < 0.001
Tascioglu LLLT A 63.5 −23.0 p < 0.001
et al LLLT B 55.0 −17.0 p < 0.001
(2012) Placebo 54.0 −8.5 p < 0.01
Fusakul et LLLT 62.6 −20.1 p < 0.05 −28.1 p < 0.05
al (2014) Placebo 48.3 −16.8 p < 0.05 −23.5 p < 0.05
LLLT versus Placebo p = 0.243 p = 0.433
*Grey blocks indicate missing information; LLLT = Low-level laser therapy; VAS = Visual Analog Scale; EOT = End of Treatment; mm = millimeters; F/U =
Follow Up

did not measure self-reported symptom severity and and placebo treatment for pain at the end of the treat-
function status. ment period. Tascioglu, Degirmenci, Ozkan, and
Hand grip strength was tested in five of the articles Mehmetoglu (2012) and Shooshtari et al. (2008)
(Chang, Jiang, Yeh, and Tsai, 2008; Evcik et al, 2007; reported significant improvement in both the LLLT
Fusakul, Aranyavalai, Saensri, and Thiengwittayaporn, and placebo groups at end of treatment. Jiang et al.
2014; Shooshtari et al, 2008; Tascioglu, Degirmenci, (2011) reported significant differences between LLLT
Ozkan, and Mehmetoglu, 2012), while three articles and placebo for both mild and moderate groups at
tested pinch grip strength (Chang et al, 2008; Evcik cessation of treatment in favor of the LLLT group.
et al, 2007; Fusakul, Aranyavalai, Saensri, and Abid Ali, Ja’afar, and Hasan (2012) reported a signifi-
Thiengwittayaporn, 2014). Chang, Jiang, Yeh, and cant pain reduction in the LLLT group at cessation of
Tsai (2008) tested both digital prehension and lateral treatment which persisted at 2-week follow-up in com-
prehension of pinch grip strength. parison to the placebo group.

Effectiveness Immediate and intermediate effectiveness reported


for symptom severity score, self-reported hand
The effectiveness of LLLT compared to sham laser function, and grip strength
(control group) for treatment of adults with CTS is Symptom Severity Score (SSS). Chang, Jiang, Yeh, and
categorized into four main groups, namely, Pain, Tsai (2008) reported no significant difference between
Symptom Severity Score, Functional status Score, and LLLT and placebo for SSS at end of treatment, but a
Strength Measures. Please note that only the results of significant difference was reported at 2-week follow-up
the studies that reported before (baseline) and after (p = 0.006). Jiang et al. (2011) reported significant
treatment values (e.g. mean, mean change and mea- difference between LLLT and placebo for only the
sures of variability – standard deviation (SD) for the mild group at end of treatment (p < 0.001). Abid Ali,
different variables were tabulated in Tables 3, 4, and 5. Ja’afar, and Hasan (2012) reported a significant
improvement (p < 0.001) in LLLT treatment for the
Immediate and intermediate effectiveness reported SSS compared to the placebo treatment. Tascioglu,
for pain Degirmenci, Ozkan, and Mehmetoglu (2012) found
Fusakul, Aranyavalai, Saensri, and Thiengwittayaporn no significant differences among the groups at the
(2014) reported no significant difference between LLLT end of treatment, while Fusakul, Aranyavalai, Saensri,
Table 4. Means, Standard Deviations (SD) and P-values for symptom severity score and functional status score.
Symptom Severity Score Functional Status Score
Baseline Baseline
Score EOT within F/U within 12wks F/ 12wks F/U Score EOT within F/U within 12wks F/ 12wks F/U
[mean & EOT [mean same group F/U [mean same group U [mean within same [mean & EOT [mean same group F/U [mean same group U [mean within same
SD] & SD] P Value & SD] P Value & SD] group P value SD] & SD] P Value & SD] P Value & SD] group P value
Irvine et al LLLT 81±9 85±11 p = 0.043
(2004)# Placebo 72±8 77±10 p = 0.034
Chang et al LLLT 30.80±0.75 21.67±0.58 19.35±0.63 18.72±0.84 13.11±0.63 11.04±0.43
(2008)# Placebo 27.51±0.5 25.53±0.62 28.71±0.85 18.72±0.68 17.04±0.70 19.60±1.02
LLLT versus p = 0.226 p = 0.138 p = 0.006 p = 0.997 p = 0.121 p < 0.05
Placebo P Value
Jiang et al Mild LLLT 2.68±0.68 1.9 ± *
(2011)‡ group Placebo 2.50±0.52 2.42 ± *
LLLT p < 0.001
versus
Placebo P
Value
Mode- LLLT 2.89±0.90 1.98 ± *
rate Placebo 2.49±0.43 2.44 ± *
group LLLT p>0.05
versus
Placebo P
Value
Abid Ali et al LLLT 35.9±5.2 23.8±3.7 p < 0.01 21.8 ± 2.8 p < 0.01 24.2±8.1 19.7±7.5 p = 0.07 18.8±8 p = 0.08
(2012)° Placebo 36.6±5 36.9±5 p=1 37.2 ± 4.4 p = 0.9 27.7±3.6 27±4 p = 0.9 28.5±3.5 p = 0.8
LLLT versus p < 0.001 p < 0.001 p < 0.001 p < 0.001
Placebo
P Value
Tascioglu et LLLT A 23.8±7.53 19.05±8.71 p < 0.001 19.20±6.57 14.60±5.73 p < 0.001
al (2012)# LLLT B 23.4±6.46 17.70±4.68 p < 0.001 16.25±5.78 12.85±3.54 p < 0.001
Placebo 24.65±7.22 20.40±8.4 p < 0.01 17.25±4.89 14.65±6.31 p < 0.05
Fusakul et al LLLT 2.10±0.68 1.68±0.66 p < 0.05 1.49±0.58 p < 0.05 2.07±0.67 1.75±0.62 p < 0.05 1.53±0.57 p < 0.05
(2014) ‡ Placebo 1.68±0.56 1.43±0.49 p < 0.05 1.35±0.51 p < 0.05 1.77±0.62 1.54±0.62 p < 0.05 1.37±0.49 p < 0.05
LLLT versus p = 0.291 p<0.05 p = 0.886 p = 0.712 p = 0.406 p = 0.313
Placebo
P Value
* SD for mean at EOT not provided.; Grey blocks indicate missing information; LLLT = Low-level laser therapy; VAS = Visual Analog Scale; EOT = End of Treatment; F/U = Follow Up; ‡ = Used the Boston Questionnaire; # = Used the
Levine Questionnaire; ° = did not indicate which questionnaire they have used
PHYSIOTHERAPY THEORY AND PRACTICE
9
10
M. BURGER ET AL.

Table 5. Means, Standard Deviations (SD) and P-values for hand and pinch grip strength.
Hand Grip Strength Pinch Grip Strength
12wks F/U
Baseline 12wks F/ within
Baseline EOT within F/U within 12wks F/U 12wks F/U Score EOT EOT within F/U F/U within U same
Score [mean EOT [mean same group F/U [mean same group [mean & within same [mean & [mean & same group [mean & same group [mean & group
& SD] & SD] P Value & SD] P Value SD] group P value SD] SD] P Value SD] P Value SD] P value
Evcik et al LLLT 19.4 ± 6.3 22.4±6.7 p<0.01 22.8 ± 6.9 p = 0.005 4.4±1.5 5.2±1.5 p<0.001 5.7±1.6 p<0.001
(2007)*
Placebo 18.0 ± 7.3 19.7±6.5 p>0.05 19.6 ± 7.3 p>0.05 4.1±1.3 4.6±1.5 p<0.01 4.8 ± 1.5 p = 0.03
Chang et al LLLT 17.77 ± 4.37 19.71±4.67 21.19±4.12 4.33±1.37 4.95±1.30 5.20±0.83
(2008)*
Placebo 18.34 ± 5.17 18.26±4.55 17.38±3.56 4.69±1.2 4.7±1.17 4.43±1.06
LLLT versus p = 0.748 p = 0.415 p<0.05 p = 0.466 p = 0.583 p<0.05
Placebo P
Value
Shooshtari LLLT 19.81 ± 5.6 22.86±5.3 p<0.001
et al
(2008)*
Placebo 21.46 ± 6.23 21.52 ±6.05 p = 0.801
Tascioglu LLLT A 47.25 ± 14.37 52.25±10.82 p<0.05
et al
(2012)#
LLLT B 53.25 ± 20.21 58.75±17.54 p<0.05
Placebo 49.25 ± 13.79 53.85±16.34 p<0.05
Fusakul et al LLLT 21.22±1.25 22.65±1.17 p<0.05 24.49±1.15 p<0.05 4.29±0.42 8.0±3.56 p<0.05 5.40±0.28 p<0.05
(2014)#
Placebo 22.56±1.07 23.2±0.99 p>0.05 23.60±1.0 p>0.05 4.21±0.27 4.65±0.30 p>0.05 5.47±0.31 p<0.05
LLLT versus
Placebo
P Value p = 0.414 p = 0.313 p = 0.554 p = 0.169 p = 0.112 p = 0.806
Grey blocks indicate missing information; LLLT = Low-level laser therapy; VAS = Visual Analog Scale; EOT = End of Treatment; F/U = Follow Up; # = measurements in pounds; * = measurement in kilograms
PHYSIOTHERAPY THEORY AND PRACTICE 11

and Thiengwittayaporn (2014) reported a significant Discussion


improvement (p < 0.05) in favor of the LLLT group at
This is the first systematic review on the effectiveness of
end of treatment.
LLLT alone, utilizing different dosages and treatment
methods, compared to placebo or sham treatment for
Functional Status Score (FSS). Abid Ali, Ja’afar, and
adults with CTS. The nine RCT’s that qualified for this
Hasan (2012) was the only study that found a signifi-
systematic review were classified as evidence Level II
cant improvement in favor of the LLLT group for both
according to the NHMRC and were all of high metho-
end of treatment (p < 0.001) and follow up assessment
dological quality, scoring an average of 8.2/10 on the
(p < 0.001).
PEDro scale. LLLT has been clinically applied to a
Chang, Jiang, Yeh, and Tsai (2008) reported no sig-
variety of disorders and is widely used for its unique
nificant difference between the two groups at end of
advantages in analgesia and lack of adverse effects
treatment; however, they found a significant difference
(Rola, Doroszko, and Derkacz, 2013). The mechanisms
in favor of LLLT at 2-week follow-up (p < 0.05) All
for analgesic effects of LLLT are, however, poorly
other included studies measuring FSS (Fusakul,
understood and several different biochemical mechan-
Aranyavalai, Saensri, and Thiengwittayaporn, 2014;
isms have been proposed (Bjordal et al, 2006; Chow
Irvine, Chong, Amirjani, and Ming Chan, 2004;
et al, 2011; Falaki, Nejat, and Dalirsani 2014). One of
Tascioglu, Degirmenci, Ozkan, and Mehmetoglu,
the most frequently used, and sensitive pain rating
2012) found no significant differences between LLLT
scales is the 100mm VAS (Gallagher, Liebman, and
and placebo groups.
Bijur, 2001) and eight of the included studies utilized
the VAS to determine the effect of LLLT. The VAS
Grip strength. At 2-week post cessation of treatment
allows the measurement of small numeric changes in
Evcik et al. (2007) reported significant improvement in
pain severity which can equate to statistical significant
both hand (p < 0.01) and pinch grip (p < 0.001)
changes in pain scores (Bird and Dickson, 2001), parti-
strength for LLLT and a significant improvement in
cularly in larger sample sizes (Salaffi et al, 2004).
pinch grip strength (p < 0.01) for the placebo group
Statistical significant changes in pain scores on the
compared to baseline. Chang, Jiang, Yeh, and Tsai
VAS however, may not imply that the patient will
(2008) reported no significant difference between
experience a clinical significant change in pain intensity
LLLT and placebo groups at the end of treatment for
(Salaffi et al, 2004). None of the included studies deter-
digital prehension (lateral prehension was not tabu-
mined a predefined minimal clinical important differ-
lated); however, a significant difference was reported
ence on the VAS for their study patients. Todd, Funk,
in favor of the LLLT group at 2-week follow-up for
Funk, and Bonacci (1996) were the first to determine
hand grip strength (p < 0.05). Shooshtari et al. (2008)
that a mean difference of 13 mm (95% confidence
reported significant improvement in hand grip strength
interval, 10–17 mm) measured with a 100 mm VAS,
in only the LLLT group (p < 0.001) at cessation of
indicates a clinically significant change in patient pain
treatment comparing to baseline. Tascioglu,
severity. Clinical significant changes in pain are how-
Degirmenci, Ozkan, and Mehmetoglu (2012) reported
ever not uniform along the VAS spectrum. Bird and
a significant improvement in all three groups at the end
Dickson (2001) found that for initial pain scores of
of treatment compared to baseline, but found no sig-
67–100 mm a mean minimum difference of 28 ±
nificant difference between the groups. Fusakul,
21mm was needed for a clinical significant change,
Aranyavalai, Saensri, and Thiengwittayaporn (2014)
indicating that patients with a higher level of pain
reported no significant differences between the LLLT
(≥67 mm) would require a greater absolute change in
and placebo groups at the end of treatment for both
VAS score to experience clinical pain relief. Patients
pinch grip and hand grip strength.
with a mean VAS score between 34–66 mm displayed a
minimal clinical significant change in pain of 17 ±
Long-term effectiveness reported for pain, symptom
10 mm, while in the patients with a VAS score of less
severity score, functional status score, and grip
than 34 mm was the mean clinical significant change
strength
similar to Todd, Funk, Funk, and Bonacci (1996),
Evcik et al. (2007) and Fusakul, Aranyavalai, Saensri,
namely 13 mm.
and Thiengwittayaporn (2014) reported no significant
Five of the included studies (Abid Ali, Ja’afar, and
differences at 12 weeks between the LLLT and the
Hasan, 2012; Fusakul, Aranyavalai, Saensri, and
placebo groups for pain, symptom severity score, self-
Thiengwittayaporn, 2014; Jiang et al, 2011; Shooshtari
reported hand function and grip strength (Tables 3, 4,
et al, 2008; Tascioglu, Degirmenci, Ozkan, and
and 5).
12 M. BURGER ET AL.

Mehmetoglu, 2012) provided mean scores for baseline Aranyavalai, Saensri, and Thiengwittayaporn, 2014;
and follow-up assessment of pain on the VAS (Table 3). Jiang et al, 2011; Shooshtari et al, 2008; Tascioglu,
Shooshtari et al. (2008) indicated that the baseline Degirmenci, Ozkan, and Mehmetoglu, 2012) that pro-
values for pain in both the LLLT and placebo groups vided mean scores for baseline and follow-up assessment
were ≥67 mm. Although both groups had a significant of pain on the VAS demonstrated a clinical significant
reduction in pain (p < 0.001), the mean reduction in improvement for pain on the VAS in the LLLT group
the LLLT group was 28.2.mm, while the mean reduc- for end of treatment and short-term follow-up.
tion in the placebo was only 3.9 mm (Table 3). VAS Bird and Dickson (2001) stated that when utilizing
score baseline values for pain in the moderate LLLT the VAS to assess changes in pain, the patients’ initial
and placebo groups in Jiang et al. (2011) were ≥ 67 mm. pain level would provide greater understanding as to
There was a significant reduction in pain by the end of the clinical effectiveness of therapy compared to only
treatment in favor of the moderate LLLT group (p < providing mean VAS score changes or p-values for
0.01) and although both groups displayed considerable between group changes. Since the effect of LLLT in
reduction in pain (LLLT group: –31.7 mm; placebo pain reduction seems promising, future research should
group: –20.1 mm), pain reduction was only clinical clearly indicate patients’ initial pain level scores on the
significant in the LLLT group. The mean baseline VAS and identify the minimal clinical important dif-
VAS score value for the LLLT group in Abid Ali, ference to use as a criterion for assessing the effects of
Ja’afar, and Hasan (2012) was ≥ 67 mm and the therapy. Setting a minimal clinical important difference
group displayed a significant reduction in pain (p < will also assist with calculating the correct sample size
0.01) with a mean clinical significant change of – to show efficacy of treatment (Salaffi et al, 2004).
45.5 mm at the end of treatment and –50.4 mm at The results of this review do not provide sufficient
follow-up. Both the mean baseline values for VAS for evidence to guide clinical practice on the use of LLLT
the LLLT and placebo groups in Tascioglu, Degirmenci, in adults with CTS to improve symptom severity, func-
Ozkan, and Mehmetoglu (2012) and Fusakul, tional score and grip strength. There are multiple fac-
Aranyavalai, Saensri, and Thiengwittayaporn (2014) tors that could have impacted the lack of clear evidence
were between 34–66 mm. Although both the LLLT for the benefit of LLLT. The efficacy of laser therapy
groups (A and B) and the placebo group in Tascioglu, depends on its treatment method, dose and type of
Degirmenci, Ozkan, and Mehmetoglu (2012) had a laser used. It was difficult to compare the results of
significant reduction in pain compared to baseline (p the studies due to the heterogeneity in laser dosage,
< 0.001 and p < 0.01 respectively); only the LLLT time frames of outcome measurement and inconsistent
groups A and B showed a clinical significant mean reporting of the results in the studies. The greatest
change in pain (–23 mm and –17 mm, respectively). variations between the studies were noticed in the
Similarly, Fusakul, Aranyavalai, Saensri, and laser specifications, dosages used and treatment area.
Thiengwittayaporn (2014) reported no difference in Chang, Jiang, Yeh, and Tsai (2008) and Jiang et al.
pain VAS scores between the LLLT and placebo groups (2011) used exactly the same laser settings, as they are
at the end of treatment (p = 0.243); however, only the from the same research group in Taiwan. The wave-
LLLT group displayed a clinical significant change of – lengths, power output, frequency, and dosage of the
20.1mm. Overall, the included RCTs’ conclusions laser settings ranged widely, which could influence the
regarding the effect of LLLT on pain were misleading outcomes of the studies and thus their comparability.
and did not reflect the clinical significant improve- For example, dosages included double versus single
ments or effect sizes for the LLLT groups. beams, pulsed versus continuous modes, 15 seconds
It is interesting to note that during the 12-week versus 15 minutes session duration. Therefore, there is
follow-up assessment of pain the placebo group in a need to identify optimal laser settings to be able to
Fusakul, Aranyavalai, Saensri, and Thiengwittayaporn compare individual studies, as indicated by our findings
(2014) also demonstrated a clinical significant decrease on a dose response. The World Association of Laser
in pain compared to baseline measurements (–23.5 mm). Therapy (WALT) (2006) recommended in 2006 that
Although the results showed a mixture of statistical energy dose should be expressed in Joules (J) instead
significant and non-significant effectiveness for LLLT of Joules/cm2 (J/cm2), but these two parameters were
on pain, there was a trend of clinical significant still being used interchangeably in the included studies.
improvements in the LLLT groups at the end of treat- A therapeutic window for the treatment of CTS with
ment and short-term follow-up when taking the mean LLLT has been proposed by WALT in 2010 for
reduction in the VAS into account. The five included 780–860 nm GaAlAs Lasers (continuous or pulsed,
studies (Abid Ali, Ja’afar, and Hasan, 2012; Fusakul, mean output: 5–500 mW), namely a recommended
PHYSIOTHERAPY THEORY AND PRACTICE 13

dose of 8J with a minimum of 4J per point (cm2) and and time off from work) before they decide to include
2–3 points (or cm2) of irradiation per treatment ses- LLLT in their treatment program for CTS. Careful
sion. For 904 nm GaAs Lasers, a minimum dose of 2 J consideration needs to be given to using optimal ther-
per point for 2–3 area points (cm2) are recommended apeutic dosages as recommended by WALT. Bjordal
(World Association of Laser Therapy, 2010). An impor- (2012) proposed that if future research trials follow
tant observation was made when comparing the indi- the WALT-recommended doses it shall lead to at least
vidual studies’ LLLT energy dosages to the general 80% positive predictive values for the therapeutic
effectiveness of the treatment. Studies that used effects for LLLT. Researchers should try to identify
780–860 nm Lasers and energy dosages of 9–11 J/cm2 the minimal clinical meaningful difference as a criter-
or 10.8J reported a more favorable outcome for the ion for assessing the clinical significant effects of LLLT
LLLT groups for pain, symptom severity and functional therapy not only for pain but also for symptom sever-
ability as well as grip strength compared to a control/ ity, function and strength. Clinical trials can only influ-
sham group (Chang, Jiang, Yeh, and Tsai, 2008; Jiang ence clinical practice if researchers not only determine
et al, 2011; Lazovic, et al, 2014; Shooshtari et al, 2008). whether the treatment has an effect, but also if they
Energy dosage of 3J and 6J (Tascioglu, Degirmenci, determine how big the effect is (Herbert, 2000).
Ozkan, and Mehmetoglu, 2012) was reported only to Researchers should thus not only focus on and report
be clinical effective for pain for the LLLT group, while statistical significant values, but also provide effect sizes
no differences were found for symptom severity, func- to help readers to understand the magnitude of differ-
tional status, and grip strength between the LLLT and ences found and the meaningful clinical effect of the
placebo groups. Energy dosages of 14–18 J (Evcik et al, therapy (Sullivan and Feinn, 2012).
2007; Fusakul, Aranyavalai, Saensri, and
Thiengwittayaporn, 2014) were only significant for the
LLLT group for hand grip strength (end of treatment Conclusion
and follow up) and for end of treatment pinch grip The heterogeneous nature of the interventions of the
strength (Fusakul, Aranyavalai, Saensri, and included research papers made it difficult to synthesize
Thiengwittayaporn, 2014). An energy dosage of 6 J/ and compare the outcomes of the various studies.
cm2 (Irvine, Chong, Amirjani, and Ming Chan, 2004) Although, no strong evidence exists concerning the
was reported as not being more effective compared to effects of LLLT on CTS in adults, there was a trend of
placebo laser in any of the outcomes measured. Abid clinical significant improvements for pain in the LLLT
Ali, Ja’afar, and Hasan (2012) reported a significant groups at the end of treatment and short-term follow-
reduction in end of treatment and follow up pain and up. Studies that used 780–860 nm Lasers and energy
symptom severity scores, but did not indicate the dosages of 9–11 J/cm2 or 10.8 J reported a more favor-
energy dosage (J/cm2) that they have applied able outcome for the LLLT groups for pain, symptom
(Table 2). No other correlation was seen between the severity and functional ability as well as grip strength at
rest of the treatment specifications and effectiveness. the end of treatment and short-term follow up.
This suggests that LLLT energy dosage of 9–11 J/cm2 Currently, there is a lack of evidence for the long-
or 10.8 J for 780–860 nm Lasers results in a more term effectiveness of LLLT for CTS.
favorable outcome for CTS for pain, symptom severity,
and functional ability as well as grip strength which is
in accordance with the recommended treatment Conflict of interests
dosages by WALT. The authors have stated that they had no interests that might
The strengths of this review are that a systematic be perceived as posing a conflict or bias.
search strategy was conducted utilizing seven scientific
databases. Each step of the review was completed inde-
pendently by at least two investigators and data were References
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