manual theramanual therapy for osteoarthritis of the hip or kneep
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2.1. Inclusion criteria
Studies were included if they 1) were a randomised clinical trial
(RCT), 2) included subjects with clinical or radiographic diagnosis of
hip or knee OA, 3) one study group received manual therapy alone
compared to either no intervention or another intervention, and 4)
if pain and/or physical function outcomes were measured.
Manual therapy was dened for the purposes of the review as
manipulation (high velocity, low amplitude), mobilisation (low
velocity small or largeamplitude), massage or other manual therapy
techniques, excludingno-touch techniques (Reid andRivett, 2005).
2.2. Exclusion criteria
A study was excluded if it was not published as full-text, not inEnglish language, participants were post-surgery, it was not an RCT
or participants were not humans.
2.3. Data extraction and analysis
Data extraction was carried out independently by three
researchers (HF, AB, TC) using a standardised data extraction form,
which was modied from a Cochrane review group form (Cochrane
Cystic Fibrosis and Genetic Disorder Group, 2009). Means and stan-
dard deviations (SDs) for the relevant outcomes were extracted for
short-term (post-treatment) and long-term follow-up (at least six
months) and reported as standardised mean difference (SMD). Hed-
ges effect size (ES) which provides an adjustment for small sample
bias was used (Deeks et al., 2007). Change scores were used whereavailable. All data were entered in RevMan version 5 (Copenhagen:
The Nordic Cochrane Centre, 2008). Efforts were made to contact the
original authors to obtain the data and when this was not available,
pooled SDs were estimated from the condence interval (CIs) using
methods recommended by the Cochrane Collaboration (Higgins and
Green, 2009). Statistical signicance was set at p < 0.05. Cohens
effectsizeswereusedto describethe sizeof theeffect, where0.2e0.49
represented a small effect size, 0.5e0.79 represented a moderate
effect size and>0.8 denoted a large effect size (Cohen,1977).
2.4. Risk of bias assessment
Two authors (HF, AB or TC) independently assessed the risk of
bias for each article, using criteria recommended by the Cochrane
Back Pain Review Group (vanTulder et al., 2003).A study witha low
risk of bias was dened as a trial fullling 6 or more of the 11
criteria, whilst a study with less than 6 of the criteria was classied
as having a high risk of bias. In the case of disagreements authors
tried to reach consensus and if necessary a third author assessed
the article to resolve disagreements. Just one item in one study
required adjudication from the third author.
A qualitative analysis of the levels of evidence using the grading
system described by Tugwell and OShea (2004)and recommended
by the Cochrane Musculoskeletal Group was performed (Table 1).
3. Results
3.1. Trials
The search yielded 1209 potentially eligible studies. Following
the exclusion process (Fig. 1), eight articles which had manual
therapy as a treatment component remained. Four articles which
examined manual therapy in combination with exercise were
excluded (Bennell et al., 2005; Deyle et al., 2005, 2000; Stoneman,
2001). The four remaining studies included manual therapy as
a sole intervention and met the inclusion criteria.
3.2. Characteristics of the included studies
All four studies were single-centre trials conducted in the
Netherlands (Hoeksma et al., 2004), Australia (Pollard et al., 2008),
the USA (Perlman et al., 2006) and South Africa (Tuckeret al., 2003).
Three studies were parallel design (Hoeksma et al., 2004; Pollard
et al., 2008; Tucker et al., 2003), while one was a crossover
design where a control group received the intervention after an 8-
week period (Perlman et al., 2006).
Only one study had a long-term follow-up period of 29 weeks
(Hoeksma et al., 2004). One had a medium-term follow-up of 16
weeks (Perlman et al., 2006), however, as this was due to the cross-
over of control participants to the intervention, between-group datawere available only for the short-term follow-up, whilst two had
short-term follow-ups only (Pollard et al., 2008; Tucker et al., 2003).
Three studies recruited people with knee OA (Perlman et al.,
2006; Pollard et al., 2008; Tucker et al., 2003) and one recruited
participantswithhip OA(Hoeksma et al., 2004). Sample sizesranged
from 43 to 109 individuals. Two studies undertook power calcula-
tions to estimate sample size (Hoeksma et al., 2004; Perlman et al.,
2006). Recruitment of participants varied between studies. Two
usedmedia advertisements(Pollard et al., 2008; Tuckeret al., 2003),
one recruited fromorthopaedic and rheumatology clinics (Hoeksma
et al., 2004) and one recruited from primary care physicians, senior
livingfacilitiesand rheumatologycentres(Perlman etal., 2006).Two
studies recruited participants with mild to moderate OA (Pollard
et al., 2008; Tucker et al., 2003) and one included subjects of alldegrees of severity (Hoeksma et al., 2004). Perlman et al. (2006)
included those with WOMAC pain scores between 40 and 90 on
the100mm VASscale.One studyexcludedend-stage OAon thebasis
that the manipulation treatmentwas contra-indicated (Tuckeret al.,
2003). Mean baseline pain, as measured with VAS was lower than
40 mm (on a 100 mm scale) in three studies (Hoeksma et al., 2004;
Tucker et al., 2003; Pollard et al., 2008),but between 60 and 70mm
in the study byPerlman et al. (2006).Comparison of baseline func-
tion between thefourtrials was notpossibledueto thedifferences in
function outcomes used. Two studies (Hoeksma et al., 2004;
Perlman et al., 2006) used the American College of Rheumatology
criteria (Altman et al.,1991,1986) whilstthe other two (Pollard et al.,
2008; Tucker et al., 2003) used other criteria (Forman et al., 1983;
Manek and Lane, 2000) to diagnose OA.
Table 1
Levels of Evidence (Tugwell and OShea, 2004).
Level of evidence Description
Platinum At least two RCTs with sample size of at least 50 per group.
If studies did not nd a statistically signicant difference,
they must have been adequately powered for a 20% relative
difference in the relevant outcome. Both patients and
assessors must have been blinded for outcomes and
treatment allocation concealed. Withdrawals>
80% shouldhave had appropriate follow-up including imputations
based on methods such as last observation carried
forward (LOFC).
Gold At least one RCT fullling the same criteria as platinum.
Silver A randomised trial that did not meet the above criteria.
Could also include evidence from at least one study of
nonrandomised cohorts who did and did not receive
the therapy. A randomised trial with a head to head
comparison of agents was considered silver level,
unless a reference was provided to one of the agents
to a placebo showing at least a 20% relative difference.
Bronze At least one high-quality case series without controls,
including before/after studies where subjects acted as
their own controls or if the conclusion was based on
expert opinion from clinical experience.
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3.3. Interventions
The types of manual therapy differed between studies. Twoused
chiropractic manipulation (Pollard et al., 2008; Tucker et al., 2003).
Manipulation and muscle stretching delivered by physiotherapists
was used by Hoeksma et al. (2004), and massage therapy using
Swedish full-body therapeutic massage was provided by massage
therapists (Perlman et al., 2006). Details of the interventions are in
Table 2.
All four studies had two group allocations but comparisons
differed. One compared manual therapy to exercise therapy
(Hoeksma et al., 2004), one compared to Meloxicam (a non
steroidal anti-inammatory drug) (NSAID) (Tucker et al., 2003) and
one compared to a placebo intervention of palmar contact followed
Step 1Computer database search(n=2557)
Medline (PubMed) (n=591)
Medline (EBSCO) (n=258)
Medline (OVID) (n=268)
Cinahl (EBSCO) (n=234)
ISI (Web of Knowledge) (n=378)
Cochrane Library (n=109)PsychINFO (n=166)
PEDro (n=234)
AMED (n=53)
Embase (n=266)
Duplicate articles excluded (n=1348)
Step 2Screening of title for inclusionexclusion (n= 1209)
Unrelated articles excluded basedon title (n=1123)Not manual therapy ( n=634)
Not RCT (n=259)Not OA (n=73)Not lower limb (n=42)Not humans (n=13)Not written in english (n=26)Abstract only (n=76)
Retrieved abstracts for review (n=86)
Unrelated articles excluded byabstract (n=63)Not manual therapy (n=4)Not RCT (n=47)Not OA (n=2)Not written in english (n=8)
Abstract only (n=2)
Step 3Retrieved full articles for full qualityreview (n= 23)
Articles excluded (n=15)Not manual therapy (n 9)Not RCT (n =2)Not OA (n =2)Not written in english (n=1)
St ep 4Articles with manual therapycomponent (n=8)
Articles excluded (n=4)Multimodal treatment (n=4)
Articles included in systematic reviewmanual therapy alone (n=4)
Fig. 1. Flow diagram of selection process of studies.
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low back pain (Coelho et al., 2008). Pain was also measured using
the 100 mm numerical rating scale version of WOMAC, and
a comparable difference of 20.11 mm in pain severity was
reported between the two groups. This resulted in a large effect
size of 0.94 [95% CI 0.44,1.44]. An MCID of 9.7 mm has been
reported in the WOMAC pain subscale (Ehrich et al., 2000) so
these results indicate a signicant benet of manual therapy
compared with no treatment for pain relief. Effect sizes for
changes in self-report function using the WOMAC and 50 footwalk test were smaller at 0.60 [95% CI 0.11, 1.08] and 0.62 [95% CI
0.14, 1.11] respectively (Table 4). The mean difference for WOMAC
function subscale was 15.48 mm which was greater than the
established MCID of 9.3 mm (Ehrich et al., 2000), resulting in
a signicant effect size of 0.6 [95% CI 0.1, 1.08].
3.5.2. Comparison with placebo
One study with a high risk of bias ( Pollard et al., 2008) found
a mean difference of 10.2 mm on a 100 mm VAS scale in favour of
manual therapy. Although this was greater than 1.7 mm change
considered to be clinically important, it resulted in a non-signi-
cant effect size of 0.58 [95% CI 0.04,1.20]. Function was measured
using a self-report VAS of how well activities could be performed. A
mean difference of 2.7 cm in favour of the manual therapy groupwas reported, with a signicant large effect size of 0.81 [95% CI
0.17,1.43].
3.5.3. Comparison with exercise therapy
One study with a low risk of bias (Hoeksma et al., 2004) found
a mean difference in favour of manual therapy of 9.1 mm on
a 100 mm VAS scale of pain at rest in individuals with hip OA,
resulting in a small effect size of 0.48 [95% CI 0.08, 0.87]. A similar
result occurred for pain during walking (mean difference of 9.6 mm
and effect size of 0.48 [95% CI 0.09, 0.87]). Both of these were
greater than the previously identied MCID of 1.7 mm score
(Coelho et al., 2008). A mean change of 1.5 points was found in the
100 point Bodily Pain subscale of the SF-36 health survey. This is
lower than the MCID of 7.8 points found in patients with lower limb
OA (Angst et al., 2001) and resulted in a small and non-signicant
effect size of 0.13 [95% CI 0.26,0.52]. A mean difference of 12.1
points was found on the Harris Hip Score resulting in a large effect
size of 0.85 [95% CI 0.45,1.25], whilst walking speed over 80 m
resulted in a small effect size of 0.40 [95% CI 0.01,0.79], both in
favour of manual therapy. The Physical Function SF-36 subscale
effect size was 0.09 [95% CI 0.3,0.48] which was non-signicant,
whilst the Role Physical subscale had a non-signicant effect size of
0.39 [95% CI 0.78, 0.00] in favour of exercise therapy over
manual therapy.
This was the only study to evaluate the long-term effects of
manual therapy (Table 5). A mean difference for pain at rest was
7 mm and 12.7 mm for pain when walking resulting in effect sizes
of 0.22 [95% CI 0.2,0.64] and 0.48 [95% CI 0.06,0.90] respectively.
The effect size on pain at rest was reduced from short-term follow-up and was non-signicant, but increased for pain with walking
(Table 5). There was a marginal reduction in effect size for SF-36
Bodily Pain subscale (ES 0.07 [95% 0.35,0.49]) which remained
non-signicant. Effect sizes for Harris hip score and 80 m walk test
in favour of manual therapy reduced at long-term follow-up,
resulting in effect sizes of 0.49 [95% CI 0.07, 0.91] and 0.41 [95% CI
0.01, 0.83] respectively. This resulted in a non-signicant long-
term effect of manual therapy on walking speed, whilst Harris hip
score remained signicant. Effect sizes for both SF-36 physical
function (ES 0.18[95% CI0.24, 0.60]) and role physical (ES 0.05
[95% CI 0.37, 0.47]) subscales improved from short-term follow-
up but remained non-signicant (Table 5).
3.5.4. Comparison with Meloxicam (NSAID)One study with a high risk of bias (Tucker et al., 2003) found
a mean difference of 2.07 mm in favour of manual therapy on
a 100 mm Visual Analogue Scale (VAS) pain scale (ES 0.18 [95% CI
0.33,0.69]) and no difference between groups on a 0e10
Numerical Rating Scale (NRS) (ES 0.2 [95% CI0.31,0.71]). Both of
these effect sizes were non-signicant. A difference of 1.5 on an 11-
Table 3
Risk of bias assessment.
Hoeksma Perlman Pollard Tucker
Randomisation Yes Yes Yes Yes
Allocation concealment Yes Unclear Unclear Unclear
Blinding of patient No No No No
Blinding of care provider No No No No
Bl indin g o f outc ome assessor Yes Unc lear Unc lear No
Baseline comparability Yes Yes Unclear YesCo-interventions avoided or similar Yes Unclear Unclear Unclear
Simi lar ti mi ng o f outc ome assessment s Yes Yes Yes Yes
Acceptable drop-out rate Yes Yes Yes Yes
Intention-to-treat analysis Yes Yes Yes No
Compliance acceptable? Yes Unclear Unclear Unclear
Table 4
Effect Sizes at short-term follow-up (Post-intervention).
Author Outcome Outcome Measure Manual
Therapy (n)
Control (n) Effect Size [95%CI] Favours Manual Therapy
Studies with Low Risk of Bias
Hoeksma Pain VAS rest pain 53 50 0.48 [0.08, 0.87] Yes
Pain VAS walking pain 53 50 0.48 [0.09, 0.87] Yes
Pain SF-36 Bodily Pain subscale 53 50 0.13 [0.26, 0.52] No differ enc e
Function SF-36 Physical Function subscale 53 50 0.09 [0.3. 0.48] No difference
Function SF-36 Role Physical Subscale 53 50 0.39 [0.78, 0.00] No difference
Function Harris Hip Score 53 50 0.85 [0.45, 1.25] Yes
Function 80 metre walk test 53 50 0.40 [0.01, 0.79] Yes
Perlman Pain Pain VAS 34 34 0.86 [0.37, 1.36] Yes
Pain WOMAC Pain subscale 34 34 0.94 [0.44,1.44] Yes
Function WOMAC Function subscale 34 34 0.60 [0.11, 1.08] Yes
Function 50 foot walk test 34 34 0.62 [0.14, 1.11] Yes
Studies with High Risk Of Bias
Pollard Pain VAS 26 17 0.58 [0. 04, 1.20] No differe nce
Function VAS 26 17 0.81 [0.17, 1.43] Yes
Tucker Pain NRS 30 30 0.18 [0. 33, 0.69] No differe nce
Pain VAS 30 30 0.20 [0. 31, 0.71] No differe nce
Function Patient Specic Functional Scale 30 30 0.15 [0. 36, 0.66] No differe nce
VAS
Visual Analogue Scale, NRS
Numerical Rating Scale, SF-36
Short Form-36, WOMAC
Western Ontario and McMaster Universities Index of Osteoarthritis.
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point PSFS scale was found in favour of manual therapy, resulting in
an effect size of 0.15 [95% CI0.33,0.66] which was non-signicant.
4. Discussion
This is the rstknownsystematic reviewto evaluate the effectof
manual therapy in hip or knee OA. The small number of included
studies indicates the limited research to date. Although patients
were randomly allocated to groups in all trials, the method ofrandomisation in three of the trials which used variations of pre-
prepared sealed envelopes can be subject to bias compared with
computer-generated numbers (Pocock, 1983; Schulz, 1995). Blind-
ing of treatment providers and study participants was a aw in all
studies but is difcult to achieve in non-pharmacological studies
(Boutron et al., 2003, 2004). Therefore, none of the evidence could
be graded as platinum or gold grade (Table 1). It was unclear from
three studies (Perlman et al., 2006; Pollardet al., 2008; Tucker et al.,
2003) if allocation concealment was used. Effect estimates in
studies with subjective outcomes can be exaggerated with unclear
or lack of allocation concealment or blinding (Wood et al., 2008).
There were some differences in demographic characteristics of
the patients (Table 2). Mean age of patients in the trials by Hoeksma
et al. (2004)and Perlman et al. (2006)were higher than the othertwo studies. This may be related to the inclusion of patients with
more severe OA in these two trials as age is the strongest risk factor
for the development of OA (Sharma et al., 2006). There was
a greater proportion of females to males in three trials (Hoeksma
et al., 2004; Perlman et al., 2006; Tucker et al., 2003) which is
unsurprising as the prevalence of OA is higher in women ( Felson,
2006).
There was variation in the severity of patients included in the
four trials. It was not clear from the two studies which only
included patients with mild to moderate OA (Pollard et al., 2008;
Tucker et al., 2003) how this was ascertained. Hoeksma et al.
(2004) used a recognised radiographic severity scale (Kellgren
and Lawrence, 1957) to dene severity, whilst cut-off scores of
the self-report WOMAC outcome were used to include participantsbyPerlman et al. (2006)although no explanation of how and why
these criteria were chosen was provided. Currently, there are no
established clinical denitions of what constitutes mild, moderate
or severe OA although work is ongoing within international OA
research groups to create a composite measure based on pain,
physical function and structural changes to dene states of OA
severity (Gossec et al., 2007).
All four studies were heterogeneous regarding the types of
manual therapy and comparison interventions used. Findings
suggest that manual therapy may have a benecial short-term
effect in reducing pain and improving physical function for patients
with knee OA compared with no intervention, and in hip OA
compared with exercise therapy. There is also evidence that effects
of manual therapy on pain and function can be sustained long-term
(up to 6 months) in hip OA, although the size of the effect reduced
for most outcomes. Effect size varied between studies, with larger
effect sizes in the study where the contrast was no treatment
(Perlman et al., 2006) compared with an active intervention
(Hoeksma et al., 2004;Tucker et al., 2003). When manual therapy
was compared to placebo, although the effect size was large, the
condence intervals around the effect size resulted in a non-
signicant result (Pollard et al., 2008). A type II error may explain
these results, as sample size was small and no sample size esti-mation was done. Effect estimates can also be exaggerated in trials
of lower methodological quality (Moher et al., 1998).
Pain and physical function are recommended as core outcome
measures in rheumatology research (Bellamy et al., 1997). All
studies measured pain severity using a VAS but there was incon-
sistency in physical function measurement across all studies. A
range of physical function measures was used including disease-
specic measures (WOMAC, Harris Hip Score), general health (SF-
36 subscales, patient specic functional scale), functional tests (50
foot walk and 80 m walk) and VAS-scaled questions. Both Perlman
et al. (2006) and Hoeksma et al. (2004) used self-report and
physical performance based measures of function which is rec-
ommended as they measure difference aspects of function in OA
(Stratford and Kennedy, 2006).In this review a broad denition of manual therapy was used.
There is a lack of clear description of what constitutes manual
therapy in the literature. This is evidenced by different criteria for
inclusion of studies in recent systematic reviews of manual
therapy (Camarinos and Marinko, 2009; Ho et al., 2009; Miller
et al., 2010; Reid and Rivett, 2005). In this review, three studies
used manipulation (Hoeksma et al., 2004; Pollard et al., 2008;
Tucker et al., 2003) applied to the target joint, whilst one deliv-
ered whole body soft tissue massage (Perlman et al., 2006). Joint-
based techniques have a role in activating pain inhibitory cortical
systems (Skyba et al., 2003). Manual therapy has previously been
shown to induce immediate hypoalgesia in individuals with knee
OA, compared with placebo and control conditions, with concur-
rent improvements in function (Moss et al., 2006). Cadaveric(Arvidsson, 1990; Harding et al., 2003) and human (Byrd and Chern,
1997) studies demonstrated that some joint movement does occur
with manual therapy applied to the hip but the effect may depend
on the force applied (Byrd and Chern, 1997). Massage therapy is
purported to have an effect on pain threshold, possibly through
endorphin release. It can also increase blood ow which may
release local pain mediators (Ernst, 1999). Psychological inuences
may also play a role due to practitioner and patient interaction
(Williams et al., 2007).
Manual therapy dosage, which varied between the studies, may
have inuenced results. The two studies which showed greater
effect provided treatments over ve (Hoeksma et al., 2004) and
eight weeks (Perlman et al., 2006), whilst the other two studies
treatment duration was two (Pollard et al., 2008) and three weeks
Table 5
Effect Sizes at long-term follow-up.
Author Outcome Outcome Measure Used Manual
Therapy (n)
Con tro l (n) Effect S iz e [95% CI] Fav ours Manual
Therapy
Studies with Low Risk of Bias
Hoeksma Pain VAS Pain at rest 44 44 0.22 [0.2, 0.64] No difference
Pain VAS Pain with walking 44 44 0.48 [0.06, 0.90] Yes
Pain SF-36 Bodily Pain subscale 44 44 0.07 [0.35, 0.49] No difference
Function SF-36 Physical Function subscale 44 44 0.18 [0.24, 0.60] No differenceFunction SF-36 Role Physical Subscale 44 44 0.05 [0.37, 0.47] No difference
Function Harris Hip Score 44 44 0.49 [0.07, 0.91] Yes
Function 80 metre walk test 44 44 0.41 [0.01, 0.83] No difference
VAS Visual Analogue Scale, SF-36 Short Form-36, WOMAC Western Ontario and McMaster Universities Index of Osteoarthritis.
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