Efficacy of physiotherapy management of knee joint osteoarthritis: A randomised, double blind, placebo controlled trial

Article (PDF Available)inAnnals of the Rheumatic Diseases 64(6):906-12 · June 2005with105 Reads
DOI: 10.1136/ard.2004.026526 · Source: PubMed
Abstract
To determine whether a multimodal physiotherapy programme including taping, exercises, and massage is effective for knee osteoarthritis, and if benefits can be maintained with self management. Randomised, double blind, placebo controlled trial; 140 community volunteers with knee osteoarthritis participated and 119 completed the trial. Physiotherapy and placebo interventions were applied by 10 physiotherapists in private practices for 12 weeks. Physiotherapy included exercise, massage, taping, and mobilisation, followed by 12 weeks of self management. Placebo was sham ultrasound and light application of a non-therapeutic gel, followed by no treatment. Primary outcomes were pain measured by visual analogue scale and patient global change. Secondary measures included WOMAC, knee pain scale, SF-36, assessment of quality of life index, quadriceps strength, and balance test. Using an intention to treat analysis, physiotherapy and placebo groups showed similar pain reductions at 12 weeks: -2.2 cm (95% CI, -2.6 to -1.7) and -2.0 cm (-2.5 to -1.5), respectively. At 24 weeks, pain remained reduced from baseline in both groups: -2.1 (-2.6 to -1.6) and -1.6 (-2.2 to -1.0), respectively. Global improvement was reported by 70% of physiotherapy participants (51/73) at 12 weeks and by 59% (43/73) at 24 weeks. Similarly, global improvement was reported by 72% of placebo participants (48/67) at 12 weeks and by 49% (33/67) at 24 weeks (all p>0.05). The physiotherapy programme tested in this trial was no more effective than regular contact with a therapist at reducing pain and disability.
EXTENDED REPORT
Efficacy of physiotherapy management of knee joint
osteoarthritis: a randomised, double blind, placebo
controlled trial
K L Bennell, R S Hinman, B R Metcalf, R Buchbinder, J McConnell, G McColl, S Green, K M Crossley
...............................................................................................................................
See end of article for
authors’ affiliations
.......................
Correspondence to:
Associate
Professor Kim Bennell,
Centre for Health, Exercise
and Sports Medicine,
School of Physiotherapy,
University of Melbourne,
Parkville, Victoria,
Australia 3010;
k.bennell@unimelb.edu.au
Accepted
1 November 2004
.......................
Ann Rheum Dis 2005;64:906–912. doi: 10.1136/ard.2004.026526
Objective: To determine whether a multimodal physiotherapy programme including taping, exercises, and
massage is effective for knee osteoarthritis, and if benefits can be maintained with self management.
Methods: Randomised, double blind, placebo controlled trial; 140 community volunteers with knee
osteoarthritis participated and 119 completed the trial. Physiotherapy and placebo interventions were
applied by 10 physiotherapists in private practices for 12 weeks. Physiotherapy included exercise,
massage, taping, and mobilisation, followed by 12 weeks of self management. Placebo was sham
ultrasound and light application of a non-therapeutic gel, followed by no treatment. Primary outcomes were
pain measured by visual analogue scale and patient global change. Secondary measures included
WOMAC, knee pain scale, SF-36, assessment of quality of life index, quadriceps strength, and balance test.
Results: Using an intention to treat analysis, physiotherapy and placebo groups showed similar pain
reductions at 12 weeks: 2 2.2 cm (95% CI, 22.6 to 21.7) and 22.0 cm (22.5 to 21.5), respectively. At
24 weeks, pain remained reduced from baseline in both groups: 22.1 (22.6 to 21.6) and 21.6 (22.2 to
21.0), respectively. Global improvement was reported by 70% of physiotherapy participants (51/73) at
12 weeks and by 59% (43/73) at 24 weeks. Similarly, global improvement was reported by 72% of
placebo participants (48/67) at 12 weeks and by 49% (33/67) at 24 weeks (all p.0.05).
Conclusions: The physiotherapy programme tested in this trial was no more effective than regular contact
with a therapist at reducing pain and disability.
K
nee osteoarthritis is a prevalent musculoskeletal condi-
tion affecting older people,
1
causing pain, physical
disability, and reduced quality of life. It also imposes a
considerable economic burden on the health care system.
2
Given that people over the age of 65 will comprise almost 25%
of the US population by 2040,
3
the public health problem of
knee osteoarthritis should increase.
Physiotherapy is a non-pharmacological intervention for
knee osteoarthritis recommended by the American College of
Rheumatology and the European League Against
Rheumatism.
45
It encompasses numerous treatment modes
including exercise, manual techniques, knee taping, and
education to impart patient self management strategies. Most
studies of physiotherapy for knee osteoarthritis have eval-
uated individual components, but this does not reflect typical
clinical practice. While three randomised controlled trials
have investigated a physiotherapy treatment package for
knee osteoarthritis,
6–8
only one used a placebo comparison
group.
7
Two trials reported a beneficial effect of physiother-
apy,
67
while one reported no effect.
8
However, results are
difficult to compare owing to different osteoarthritis samples
and treatments employed. Given the strong placebo effect
reported for pain outcomes in surgical and drug trials in this
patient population,
910
further placebo controlled trials of
physiotherapy are clearly needed.
To build the evidence base for non-pharmacological
management of knee osteoarthritis, we aimed to test the
efficacy of a novel multifaceted physiotherapy programme—
including functional exercise, massage, and knee taping—on
pain and disability compared with a placebo control. We also
aimed to determine whether any physiotherapy benefits
could be maintained by self management strategies. It was
hypothesised that physiotherapy would be superior to a
placebo intervention.
METHODS
Participants
A community sample was recruited in Melbourne, Australia,
through advertisements placed in local media. Selection
criteria (based on the clinical and radiological criteria defined
by the American College of Rheumatology
11
for knee
osteoarthritis) included age >50 years, knee pain on most
days of the past month (average pain severity of >4onan11
point numerical rating scale), osteophytes on x ray (as
assessed by an experienced radiologist), and pain or difficulty
in rising from sitting or climbing stairs. Exclusion criteria
included physiotherapy or knee surgery (in the previous 12
months), lower limb arthroplasty, SynviscH or intra-articular
steroid injections (in the previous six months), a systemic
arthritic condition, a severe medical condition, poor skin
condition, known allergic reaction to tape, or a body mass
index of more than 36 kg/m
2
(which would result in
difficulty in knee taping). All participants were initially
screened over the phone with regard to selection criteria and
if appropriate underwent medical screening with a project
rheumatologist (RB or GM).
The University of Melbourne human research ethics
committee approved the study and all participants provided
written informed consent.
Protocol
The trial comprised a 12 week intervention and a 12 week
follow up (fig 1). Participants were assessed immediately
Abbreviations: AQoL, assessment of quality of life index; SF-36, short
form 36 item general health questionnaire; VAS, visual analogue scale;
WOMAC, Western Ontario and McMaster Universities osteoarthritis
index
906
www.annrheumdis.com
before treatment (baseline), immediately after treatment
(final), and at 24 weeks (follow up).
Assignment
Following baseline assessment, participants were randomly
assigned to physiotherapy or placebo treatment. Simple
randomisation was employed using a computer generated
table of random numbers. An independent researcher not
involved in eligibility assessment, outcome assessment, or
treatment kept the concealed assignment scheme in a locked
cupboard in a central location. Allocation was revealed to the
treating physiotherapist by telephone at the time the
participant presented for treatment.
Interventions
Ten experienced musculoskeletal physiotherapists employed
in private practice were selected to provide geographical
coverage of greater Melbourne. Project physiotherapists
implemented both interventions at no cost to the partici-
pants. They were trained in the implementation of both the
physiotherapy and placebo intervention by JM and were
provided with a detailed instruction manual. All treatments
were individual sessions lasting 30 to 45 minutes once weekly
for four weeks, then fortnightly for eight weeks. During the
follow up period there was no contact between the
physiotherapist and the participants. The use of drugs and
other treatments was recorded.
Physiotherapy
A standardised treatment was devised (JM). This included
knee taping; exercises to retrain the quadriceps, hip, and back
muscles; balance exercises; thoracic spine mobilisation; and
soft tissue massage (table 1). Home exercises were to be done
three times daily. Participants were provided with standardised
home exercise and taping instruction sheets. Compliance with
home exercises was monitored in a log book.
Phone screening
(n = 650)
Medical screening
(n = 184)
Excluded because of
severe spinal OA (1)
Ineligible (n = 44)
• Failed inclusion criteria (25)
• Met exclusion criteria (19)
Physiotherapy
treatment
(n = 73)
Consent, baseline
assessment and randomisation (n = 140)
0 weeks
Final assessment
(n = 124)
12 weeks
Ineligible (n = 466)
• Failed inclusion criteria (295)
• Met exclusion criteria (171)
Placebo
treatment
(n = 67)
Drop-outs (n = 2)
• TKR (1)
• Health problem (1)
Drop-outs (n = 13)
• Travel reasons (2)
• TKR (2)
• Failed to attend (2)
• Health problem (4)
• Symptom flare-up (2)
• Lack of time (1)
Home exercise
and tape
(n = 59)
Follow up assessment
(n = 119)
24 weeks
No treatment
(n = 65)
Drop-outs (n = 2)
• Travel reasons (1)
• Health problem (1)
Drop-outs (n = 3)
• Health problem (2)
• Lack of time (1)
Figure 1 The trial protocol.
Physiotherapy and knee osteoarthritis 907
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Knee taping consisted of non-rigid, hypoallergenic tape
(Fixomull, Beiersdorf Australia, North Ryde) to provide skin
protection, and rigid strapping tape (Beiersdorf Australia) for
patellar adjustments, to be worn continuously
12
(table 1).
Appropriate self application of the tape once weekly (from
week 5 onwards) was assessed by the treating therapist.
During the follow up, the physiotherapy group continued
the daily home exercises and knee taping for alternate weeks
for six weeks, then as needed thereafter. Tape use and
exercise completion was recorded in a log book.
Placebo
Placebo treatment consisted of sham ultrasound (custom
made, Metron, Australia) and light application of non-
therapeutic gel (ultrasonic gel, Parker Laboratories Inc, New
Jersey, USA and Hospital Skin Care Lotion, Smith & Nephew,
Clayton, Australia).
7
The placebo participants did not receive
any intervention during the follow up period.
Masking
A blinded examiner (BM) carried out all outcome assess-
ments. Participant blinding was optimised by using a realistic
placebo intervention and by ensuring participants did not
attend for treatments or assessments concurrently. At trial
completion, participants nominated which group they
believed they had been allocated to. The data manager and
statistician were unaware of treatment allocation until
completion of analyses.
Primary outcomes
Pain on movement (over the past week) was measured by a
visual analogue scale (VAS)
13
numbered in 1 cm intervals.
Patient global change in pain (since the start of the trial) was
recorded on a five point Likert scale, ranging from 1 (much
worse) to 5 (much better). Participants were classified as
‘‘improvers’’ using two methods: those who scored their
global change in pain as 4 or 5; and those who reported a
clinically significant change in pain (>1.75 cm on VAS).
Secondary outcomes
Questionnaires
Measures of pain, disability, and quality of life included the
Western Ontario and McMaster Universities osteoarthritis
index (WOMAC),
14
the knee pain scale,
15
an 11 point
numerical VAS (average restriction of activity), the short
form 36 item general health questionnaire (SF-36),
16
and the
assessment of quality of life (AQoL) index.
17
Step test
The step test is a functional, dynamic test of standing
balance.
18
The number of times the foot can be placed up onto
a 15 cm step and returned to the floor in 15 seconds while
balancing on the symptomatic leg is recorded.
Isometric quadriceps strength
This was assessed at 60
˚
knee flexion in the sitting position
using a KinCom dynamometer (Chattecx Corporation,
Chattanooga, Tennessee, USA). A submaximal warm up
was followed by three maximal 5 s contractions with a 15 s
rest interval. The highest peak force of the three trials
normalised for body weight was used.
Sample size
Pain reduction of 1.75 cm on VAS is recommended as the
minimum clinically important difference in osteoarthritis
trials.
19
With 126 participants, the study had 90% power to
detect a difference in pain reduction of 1.75 cm between
treatment groups, assuming a standard deviation of 3.0 cm
with a significance level of 5%. Numbers were increased to
140 to allow for drop outs.
Table 1 Components of the physiotherapy intervention
Treatment component Frequency of application
Knee taping Continuous (day and night)
Taping of the patella to adjust the components of
medial glide, anterior tilt, lateral tilt and unload the
infrapatellar fat pad or pes anserinus
Reapplied at weekly intervals by therapist for first four
weeks, and by participant thereafter
Soft tissue massage of the knee performed in extension 5 min
Thoracic spine mobilisation 5 min
Performed while sitting with symptomatic leg extended
and elevated on a chair
Starting in second treatment session
Exercises
l
Buttock squeeze: isometric gluteal contraction in
sitting with co-contraction of hip adductors
5 s hold 6 5 repeats
l
Buttock rock: concentric contraction of the quadratus
lumborum with isometric contraction of gluteus
maximus in sitting
10 s hold 6 5 repeats on each side
l
Rock and stand: sit to stand exercise with isometric
contraction of hip adductors
5 repeats
l
Half squats: performed with co-contraction of the
gluteals and hip adductors
3 6 5 repeats
l
Step ups: onto a 10 cm step. Isometric contraction of
gluteals muscles onto the supporting leg while
stepping up with the other leg. Then lower back
down to floor
If able to complete 5 repeats with pain ,3 cm on VAS
5 repeats on each leg
l
Standing balance: with a piece of theraband around
the ankles, standing on one leg while moving the
other leg backwards on a diagonal
5 repeats each leg
After fourth week, increased to 10 repeats
l
Home exercise programme Three times daily
l
Exercises from the supervised exercise programme
VAS, visual analogue scale.
908 Bennell, Hinman, Metcalf, et al
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Statistical analysis
Statistical analyses, employing SPSS software, were under-
taken on an intention to treat basis using a conservative
method for replacing missing data. In the physiotherapy
participants, missing data were replaced by the placebo group
mean, and vice versa for missing placebo data, except for the
global change outcome where missing data from participants
in both groups were allocated a score of 3 (‘‘no change’’). In
addition, a per protocol analysis was carried out to see if
results differed. For each participant, change scores were
calculated by subtracting the result of the final and follow up
assessment from those at baseline. We calculated mean
change scores within groups, and differences in change
scores between groups, with 95% confidence intervals.
Comparison of the numbers of ‘‘improvers’’ in each treat-
ment group was done with x
2
tests.
RESULTS
Between May 2000 and May 2002, 650 volunteers were
screened. Of these, 140 enrolled in the trial with 73
randomised to physiotherapy and 67 to placebo (fig 1).
Groups were comparable at baseline (tables 2 and 3). The 12
week programme was completed by 124 participants (59
physiotherapy, 65 placebo) with 13 drop outs in the
physiotherapy group (18%) and two in the placebo group
(3%). Follow up was completed by 119 participants (85%) (56
physiotherapy, 63 placebo). Those participants who dropped
out did not differ at baseline from those who completed final
measurements (except for height, where the completers were
shorter).
Change immediately following intervention
Primary outcomes
Both groups showed reduced pain on movement following
intervention (table 3). Pain reduction averaged 42% with
physiotherapy treatment and 38% with placebo treatment.
Seventy per cent of physiotherapy participants and 72% of
placebo participants reported global improvement. A clini-
cally relevant reduction in pain on VAS was reported by 53%
of the physiotherapy group and 47% of the placebo group.
The proportion of ‘‘improvers’’ with each intervention was
similar (both p.0.05).
Secondary outcomes
Both groups showed similar improvements on all secondary
outcomes (table 3) except for quadriceps strength, where
there was no change in either group.
Change at follow up
Primary outcomes
Movement pain (VAS) remained significantly lower at follow
up than at baseline in both groups (table 3). A similar
percentage of physiotherapy (59%) and placebo (50%)
participants reported global improvement (from the start of
the trial) (p = 0.309). Similar proportions of physiotherapy
participants (58%) and placebo participants (42%) reported a
clinically relevant reduction in pain on VAS (p = 0.069).
Secondary outcomes
With both interventions, most secondary measures remained
improved from baseline (table 3). However, a significantly
greater improvement in quality of life was evident in the
physiotherapy group compared with the placebo group.
Per protocol analysis
When the primary outcomes were reanalysed using only the
data from those who completed the trial, there was no
difference between groups for pain reduction and global
improvement at 12 weeks (both p.0.05). At 24 weeks,
movement pain remained significantly lower than at baseline
in both groups. However, a greater proportion of physiother-
apy participants (77%) reported global improvement (from
baseline) compared with placebo participants (49%)
(p = 0.005) at this time. More physiotherapy participants
(66%) reported a clinically relevant reduction in pain on VAS
than did placebo participants (48%) (p = 0.027).
Compliance, adverse events, and co-interventions
Participants were compliant during the intervention period,
with 95% of treatment sessions attended. During the
intervention and follow up periods, 72% and 50% of home
exercise sessions were completed, respectively. During follow
up, 45% of the physiotherapy group taped their knee for a
mean (SD) of 29 (13) days. Minor and short lived adverse
events were reported during the interventions. In the
physiotherapy group, these included minor skin irritation
(48%), increased pain with exercises (22%), and pain with
massage (1%). In the placebo group, these included increased
pain (2%) and itchiness and pain with application of gel
(2%). At follow up, 8% of physiotherapy participants reported
knee/back pain associated with home exercises, while 1%
reported skin problems with taping. Drug use was similar
between the physiotherapy and placebo groups over the
treatment period (analgesics, 23% v 21%; non-steroidal anti-
inflammatory drugs, 22% v 24%; glucosamine, 3% v 6%). No
other co-interventions were reported by the physiotherapy
group, while 1% of placebo participants reported attending a
podiatrist and wearing a magnetic bandage.
Success of blinding
Sixty seven per cent of the placebo group remained blinded to
their group allocation. The assessor was unblinded for six
(10%) and two (3%) of the physiotherapy and placebo final
assessments, respectively, and for nine (16%) and two (3%)
of the physiotherapy and placebo follow up assessments.
DISCUSSION
We conducted a randomised, double blind, placebo controlled
trial of a novel multimodal physiotherapy package in a large
cohort of community volunteers with symptomatic knee
osteoarthritis. We showed significantly improved pain and
function with both physiotherapy and placebo interventions.
Table 2 Demographic features of the intervention
groups
Variable Physiotherapy (n = 73) Placebo (n = 67)
Age (y) 67.4 (8.6) 69.8 (7.5)
Height (m) 1.63 (0.08) 1.65 (0.10)
Weight (kg) 78.0 (12.1) 78.9 (12.7)
BMI (kg/m
2
) 29.3 (4.3) 28.9 (3.9)
Symptom duration
(y) 9.6 (10.0) 8.7 (7.9)
Sex 23 (30%) male 23 (34%) male
50 (68%) female 44 (66%) female
Severity on x ray* Grd 0: 3 (4%) Grd 0: 2 (3%)
Grd 1: 7 (10%) Grd 1: 8 (12%)
Grd 2: 10 (14%) Grd 2: 8 (12%)
Grd 3: 41 (56%) Grd 3: 40 (60%)
Grd 4: 8 (11%) Grd 4: 7 (10%)
Nature of
symptoms 29 (40%) unilateral 17 (25%) unilateral
44 (61%) bilateral 50 (75%) bilateral
Treated leg 49 (68%) dominant 34 (51%) dominant
24 (33%) non-dominant
33 (49%) non-
dominant
Values are mean (SD) unless otherwise indicated.
*Kellgren and Lawrence grading on antero-posterior x rays
20
; x rays not
available in six participants. Note: higher grades indicate more severe
disease; grade 0 represents isolated patellofemoral joint disease.
BMI, body mass index; grd, grade; m, months; y, years.
Physiotherapy and knee osteoarthritis 909
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Pain reduction was similar in both groups, and of a clinically
relevant magnitude in around half the participants. This
suggests that the physiotherapy package investigated in this
trial offered no greater benefits than regular contact with a
therapist.
In our study, the improvements seen immediately follow-
ing intervention could reflect the natural history of the
disease. Symptoms associated with chronic conditions such
as knee osteoarthritis typically fluctuate over time,
21
with
patients often seeking medical care or enrolling in research
when the symptoms are at their worst. Thus the next change
in symptoms is likely to be an improvement. A tendency for
extreme symptoms at baseline to return towards a more
typical state at final assessment is also known as regression
Table 3 Primary and secondary outcome scores over time according to group allocation using intention to treat analysis
Mean score (95% CI) Mean change (95% CI) Mean difference in
change between groups
(95%CI)Physiotherapy (n = 73) Placebo (n = 67) Physiotherapy Placebo
Primary outcome
VAS: Pain on movement (cm)
Baseline (0 weeks) 5.3 (4.8 to 5.7) 5.2 (4.8 to 5.6)
Final (12 weeks) 3.1 (2.7 to 3.5) 3.2 (2.7 to 3.6) 22.2 (22.6 to 21.7) 22.0 (22.5 to 21.5) 20.1 (20.8 to 0.5)
Follow up (24 weeks) 3.2 (2.8 to 3.6) 3.5 (3.0 to 4.1) 22.1 (22.6 to 21.6) 21.6 (22.2 to 21.0) 20.5 (21.2 to 0.3)
Secondary outcomes
VAS: Restriction of activity (cm)
Baseline (0 weeks) 4.7 (4.2 to 5.3) 4.8 (4.2 to 5.3)
Final (12 weeks) 3.1 (2.7 to 3.6) 2.9 (2.4 to 3.4) 21.6 (22.0 to 21.2) 21.9 (22.4 to 21.3) 0.3 (20.5 to 1.0)
Follow up (24 weeks) 2.9 (2.4 to 3.4) 3.1 (2.5 to 3.7) 21.9 (22.3 to 21.4) 21.7 (22.3 to 21.0) 20.2 (20.9 to 0.6)
WOMAC: Pain
Baseline (0 weeks) 8.2 (7.5 to 8.9) 8.0 (7.3 to 8.6)
Final (12 weeks) 6.1 (5.4 to 6.8) 5.8 (5.1 to 6.5) 22.1 (22.7 to 21.4) 22.2 (22.9 to 21.5) 0.1 (20.9 to 1.0)
Follow up (24 weeks) 5.8 (5.1 to 6.5) 6.0 (5.2 to 6.8) 22.4 (23.2 to 21.6) 22.0 (22.7 to 21.2) 20.4 (21.5 to 0.7)
WOMAC: Physical function
Baseline (0 weeks) 27.6 (25.2 to 29.9) 28.4 (26.0 to 30.7)
Final (12 weeks) 19.8 (17.4 to 22.1) 20.2 (17.7 to 22.7) 27.8 (29.7 to 25.8) 28.2 (210.6 to 25.8) 0.4 (22.7 to 3.5)
Follow up (24 weeks) 20.0 (17.4 to 22.6) 21.7 (19.0 to 24.4) 27.5 (210.1 to 25.0) 26.7 (29.3 to 24.1) 20.9 (24.4 to 2.7)
KPS: Severity
Baseline (0 weeks) 16.6 (15.5 to 17.7) 16.4 (15.5 to 17.3)
Final (12 weeks) 13.3 (12.3 to 14.2) 13.8 (12.9 to 14.8) 23.3 (24.2 to 22.4) 22.6 (23.6 to 21.5) 20.8 (22.1 to 0.6)
Follow up (24 weeks) 13.5 (12.5 to 14.5) 14.3 (13.4 to 15.3) 23.1 (24.2 to 21.9) 22.1 (23.1 to 21.0) 21.0 (22.5 to 0.6)
KPS: Frequency
Baseline (0 weeks) 23.5 (22.5 to 24.5) 22.8 (21.8 to 23.7)
Final (12 weeks) 19.2 (18.0 to 20.3) 19.7 (18.3 to 21.1) 24.3 (25.4 to 23.3) 23.0 (24.4 to 21.7) 21.3 (23.0 to 0.4)
Follow up (24 weeks) 19.4 (18.1 to 20.7) 20.3 (18.9 to 21.7) 24.1 (25.3 to 23.0) 22.5 (23.9 to 21.1) 21.7 (23.5 to 0.1)
SF-36: Bodily pain
Baseline (0 weeks) 53.7 (48.5 to 58.9) 57.0 (52.8 to 61.1)
Final (12 weeks) 65.0 (60.1 to 70.0) 66.4 (61.5 to 71.2) 11.4 (6.3 to 16.5) 9.4 (4.3 to 14.6) 2.0 (25.2 to 9.2)
Follow up (24 weeks) 60.4 (55.0 to 65.7) 61.8 (56.3 to 67.4) 6.7 (0.6 to 12.8) 4.9 (21.1 to 10.9) 1.8 (26.7 to 10.3)
SF-36: Physical function
Baseline (0 weeks) 40.8 (36.0 to 45.6) 40.8 (36.6 to 45.0)
Final (12 weeks) 53.0 (48.2 to 57.7) 48.7 (43.2 to 54.2) 12.2 (8.0 to 16.4) 7.9 (3.6 to 12.2) 4.3 (21.7 to 10.3)
Follow up (24 weeks) 50.5 (45.7 to 55.4) 46.2 (40.7 to 51.8) 9.7 (5.4 to 14.1) 5.4 (1.0 to 9.8) 4.3 (21.8 to 10.4)
SF-36: Physical role
Baseline (0 weeks) 33.7 (24.6 to 42.8) 34.7 (24.8 to 44.6)
Final (12 weeks) 48.5 (39.7 to 57.3) 50.7 (39.9 to 61.5) 14.8 (6.2 to 23.4) 16.0 (6.5 to 25.5) 21.2 (213.9 to 11.5)
Follow up (24 weeks) 47.0 (38.4 to 55.6) 46.5 (36.7 to 56.3) 13.3 (4.3 to 22.4) 11.8 (2.7 to 20.8) 1.6 (211.1 to 14.3)
AQoL
Baseline (0 weeks) 0.45 (0.41 to 0.49) 0.46 (0.42 to 0.51)
Final (12 weeks) 0.50 (0.46 to 0.53) 0.51 (0.46 to 0.55) 0.05 (0.02 to 0.07) 0.04 (0.02 to 0.07) 0.00 (20.03 to 0.04)
Follow up (24 weeks) 0.52 (0.48 to 0.56) 0.48 (0.43 to 0.52) 0.07 (0.03 to 0.10) 0.01 (20.01 to 0.04) 0.05 (0.01 to 0.10)
Quadriceps strength (N/kg)
Baseline (0 weeks) 3.9 (3.5 to 4.3) 4.0 (3.7 to 4.4)
Final (12 weeks) 4.2 (3.8 to 4.5) 4.1 (3.7 to 4.5) 0.3 (0.0 to 0.5) 0.0 (20.2 to 0.3) 0.2 (20.1 to 0.5)
Follow up (24 weeks) 4.2 (3.8 to 4.6) 4.2 (3.8 to 4.6) 0.3 (20.2 to 0.6) 0.1 (20.1 to 0.4) 0.2 (20.2 to 0.5)
Step test (n)
Baseline (0 weeks) 11.6 (10.8 to 12.4) 11.0 (10.1 to 12.0)
Final (12 weeks) 13.1 (12.4 to 13.8) 12.4 (11.4 to 13.4) 1.5 (0.9 to 2.1) 1.4 (0.7 to 2.0) 0.1 (20.7 to 1.0)
Follow up (24 weeks) 13.7 (13.0 to 14.4) 12.8 (11.9 to 13.8) 2.1 (1.5 to 2.7) 1.8 (1.1 to 2.6) 0.3 (20.6 to 1.2)
NOTE: there were no significant differences in baseline scores across intervention groups.
AQoL, assessment of quality of life index (ranging from 20.04 to 1.0, with higher scores indicating greater quality of life; CI, confidence interval; KPS, knee pain
scale (severity subscale ranging from 0 to 36 points and the frequency subscale ranging from 0 to 30 points, with higher scores indicating more severe or more
frequent pain); SF-36, Medical Outcomes Study 36 item short form (ranging from 0 to 100 points, with higher scores indicating better quality of life); VAS, visual
analogue scale (ranging from 0 = no pain to 10 = worst pain possible); WOMAC, Western Ontario and McMaster Universities osteoarthritis index (pain sco res
range from 0 to 20 points and physical function scores from 0 to 68, with higher scores indicating more severe pain/physical function).
910 Bennell, Hinman, Metcalf, et al
www.annrheumdis.com
toward the mean.
22
While we did not include a third ‘‘no
treatment’’ arm, we believe that natural history is an unlikely
explanation. Another trial conducted by our group using
identical recruitment and selection criteria and outcome
measures showed no change in pain and physical function
over six weeks in the participants receiving no treatment.
12
A possible explanation for our results is non-specific
treatment effects, often known as placebo effects. These
placebo effects may be attributed to the attention, interest,
and concern displayed by the investigator or physiotherapist,
patient expectations of treatment effects, expense and
impressiveness of the intervention, characteristics of the
healing setting, or the intense monitoring associated with a
research trial.
23 24
Placebo effects are common in individuals
with knee osteoarthritis, and have been demonstrated with a
range of sham treatments including intra-articular saline
injection,
25
simulated arthroscopic procedures,
9
and placebo
glucosamine sulphate.
10
In these studies, improvements with
sham interventions ranged from 16% to 40%. Our finding of a
38% reduction in pain with placebo is consistent with these
studies. A meta-analysis of placebo controlled clinical trials
26
has shown that placebos have their greatest effect on
continuous subjective outcomes and in the treatment of
pain. Given that psychological variables such as anxiety,
helplessness, and pain coping have been correlated with pain
and disability in knee osteoarthritis,
27 28
and our successful
blinding of the participants, it is not surprising that such a
strong placebo response was seen in our trial. Furthermore, it
must be noted that our placebo treatment involved physical
contact with the skin. It is feasible that this had direct effects
on the knee, as touch can reduce pain and disability in knee
osteoarthritis.
29
Another likely cause of the non-significant difference
between groups following intervention may relate to our
use of a novel programme with an emphasis on motor control
and function, particularly around the hip and pelvis, rather
than on lower limb strengthening and aerobic fitness. The
exercise component was similar to that used by Quilty et al,
8
who, like us, showed little increase in quadriceps strength
and no overall effect of the physiotherapy programme. These
non-significant findings may highlight the importance of
muscle strengthening exercises for knee osteoarthritis,
particularly given the significant reductions in pain following
resistance training in other studies.
30 31
Taping was a component of our programme and has been
shown by us
12
and others
30
to be effective in this patient
population when applied by a trained therapist. In our
present study and that of Quilty et al,
8
the taping was
generally carried out by the patients themselves. The non-
significant effects in both studies brings into question the
effectiveness of patient applied tape in knee osteoarthritis.
Future studies should investigate the efficacy of self versus
therapist application of tape, as this will influence the clinical
applicability of this form of treatment.
Our physiotherapy programme was standardised, with
limited scope for exercise progression; given the heterogene-
ity of our sample, it is possible that it was less effective for
some participants than for others. This may have contributed
to our lack of a significant between group differences. It is
possible that greater improvements may have been noted
with individualised physiotherapy treatment. This is certainly
feasible given evidence suggesting that knee osteoarthritis
subgroups respond differently to treatment interventions.
6
Before our study, only three randomised controlled trials of
multimodal physiotherapy programmes for knee osteoarthri-
tis had been conducted.
6–8
Of these, only Quilty et al
8
used a
comparable physiotherapy programme to ours but in a cohort
with predominant patellofemoral osteoarthritis. As in our
study, the investigators found no difference between groups
in pain or function. In the only other placebo controlled trial
of physiotherapy, Deyle et al
7
found significant benefits with a
four week programme. The different results compared with
ours may reflect a more homogeneous osteoarthritis group
and an individually tailored treatment programme with a
greater emphasis on quadriceps strengthening. In the third
trial, physiotherapy delivered individually or in a group
exercise class format resulted in greater improvement than in
a no treatment control group.
6
No placebo group or controlled
follow up was available in this study to compare with ours.
We used a conservative method to allocate values for
missing data in our intention to treat analysis, and the effect
of the drop outs is unknown. However, when reanalysing the
data on a per protocol method, similar results were found at
12 weeks. At 24 weeks, the physiotherapy group reported
greater global improvement than the placebo group. These
results suggest that placebo effects are less likely to be
maintained once contact with the therapist has ceased.
Future research should focus on determining which factors
influence the treatment responsiveness of patients with knee
osteoarthritis. As knee osteoarthritis is a heterogeneous
condition, it is possible that subgroups of patients may
respond differently to different modes of physiotherapy. This
will allow the development of targeted physiotherapy
programmes for particular subgroups. Economic analyses
should also be incorporated into research designs to allow
clinicians and health care providers to determine the most
cost-effective forms of physiotherapy treatment.
ACKNOWLEDGEMENTS
This work was funded by the National Health and Medical Research
Council (grant No 114277). KC is supported by a NHMRC
postdoctoral fellowship. We thank Dr Mike Smith for evaluating
the radiographs and Helen Archer, Jane Burman, Emma Colson,
Lena Fiddelaers, Peter Kent, Jean Leaf, Janet Pullar, Christine
Roberts, Ann Ryan, and Simon Wilson for ad ministering the
interventions.
Authors’ affiliations
.....................
K L Bennell, R S Hinman, B R Metcalf, J McConnell, K M Crossley,
Centre for Health, Exercise and Sports Medicine, School of
Physiotherapy, University of Melbourne, Parkville, Victoria, Australia
R Buchbinder, Monash Department of Clinical Epidemiology, Cabrini
Hospital and Department of Epidemiology and Preventive Medicine,
Monash University, Melbourne, Australia
G McColl, Department of Medicine, Royal Melbourne Hospital,
University of Melbourne
S Green, Monash Institute of Health Services Research, Monash
University
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    • "For example, Veenhof et al. reported that only 37 of 90 (41%) and 37 of 102 (36%) knee OA patients reported to be improved after 13 weeks of following a behavioral graded activity exercise program , respectively a usual care program including exercises (Veenhof et al., 2006). Bennel et al. reported that 59% of knee OA patients indicated to be improved after 12 weeks of receiving a physiotherapy program (including exercises) (Bennell et al., 2005 ). A sufficiently high adherence , i.e. the number of sessions attended divided by the number of sessions prescribed, has been shown to be an important prerequisite for the exercise-induced benefits (Holden et al., 2014; Marks, 2012; Roddy et al., 2005 ). "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Exercise effectiveness is related to adherence, compliance and drop-out. The aim of this study is to investigate if exercise-induced pain and health status are related to these outcomes during two exercise programmes in knee osteoarthritis patients. Methods: Symptomatic knee osteoarthritis patients were randomly allocated to a walking or strengthening programme (N=19/group). At baseline, patients were categorized according to their health status. Exercise adherence and compliance were calculated and drop-out rate was registered. For exercise-induced pain, patients rated their pain on an 11-point numeric rating scale (NRS) before and after each training session. Before each session the maximal perceived pain of the last 24h (NRSmax24) was assessed. Patients rated their global self-perceived effect (GPE) on a 7-point ordinal scale after the intervention period. Results: 53% of the participants felt they improved after the programme, 6 patients dropped out. The mean adherence and compliance rates were higher than .83 in both groups. Worse health and higher exercise-induced pain were seen in drop-outs. NRSmax24 during the first 3weeks did not significantly increase compared to baseline, but correlated negatively with adherence during the home sessions (-.56, p<.05). Lower adherence during supervised sessions was significantly related with higher pre-exercise pain scores (ρ=-.35, p<.05). Conclusion: Patients who drop-out show a worse health condition and higher exercise-induced pain levels compared to patients that retained the programme.
    Full-text · Article · Sep 2015
    • "Between group N ¼ 29 Within group N ¼ 28 Between group N ¼ 28 Within group N ¼ 28 Abbott et al., 2013 Aglamis et al., 2008 ✓ ✓ ✓ ✓ Avelar et al., 2011 ✓ # Baker et al., 2001 ✓ ✓ ⃡ ✓ Bautch et al., 1997 ✓ Bennell et al., 2005 ⃡ ✓ ⃡ ✓ Bennell et al. 2010 ✓ ✓ Brismee et al., 2007 ✓ ✓ ✓ ✓ Dias et al., 2003 ✓ ✓ Durmus et al., 2012 ✓ ✓ Ettinger et al., 1997+ ✓ ✓ Farr et al., 2010 ✓ Fitzgerald et al., 2011 ⃡ ✓ Foroughi et al., 2011 ✓ ✓ Foy et al., 2011 ✓ ✓ Hasegawa 2010 ✓ ✓ ✓ ✓ Jenkinson et al., 2009 ✓ ⃡ ✓ ✓ Kawasaki et al., 2008 ✓ ✓ Kawasaki et al. 2009 ⃡ ⃡ Keefe et al., 2004 ⃡ Kirkley et al., 2008 Lim et al., 2008 ✓ ⃡ McCarthy et al., 2004 McKnight et al., 2010 ✓ ✓ Messier et al., 2000 # ✓ Messier et al. 2007 ⃡ # Mikesky et al., 2006 ⃡ Miller et al., 2006 ✓ ✓ Ni et al., 2010 ✓ ✓ Olejerova et al., 2008 O'Reilly et al., 1999 ✓ ✓ ✓ ✓ Osteras et al., 2012 ⃡ Peloquin et al., 1999 ✓ ✓ # # Pisters et al., 2010 ✓ ✓ Rejeski et al., 2002+ # ✓ # # Rogind et al., 1998 ⃡ # ⃡ # Salancinski et al., 2012 ✓ ✓ ⃡ ⃡ Sayers et al., 2012 ⃡ ⃡ ⃡ ⃡ Schlenk et al., 2011 ⃡ ✓ Silva et al., 2008 ✓ ✓ Simao et al., 2012 # ⃡ Somers et al., 2012 ✓ # ✓ # Song et al., 2003 ✓ ✓ Talbot et al., 2003 ⃡ ⃡ ✓ Thomas et al., 2002 ✓ ✓ Topp et al., 2002 ⃡ ✓ ⃡ # Wang et al., 2009 ✓ ✓ ✓ ✓ Wang et al. 2011 ✓ Key: + ¼ findings from primary paper and follow up papers, ✓ ¼ significantly lower pain in physical activity group over time or compared to non-physical activity group/ significantly better physical function in physical activity group over time or compared to non-physical activity group. 4 ¼ no significant difference over time or between groups. "
    [Show abstract] [Hide abstract] ABSTRACT: To determine whether long-term physical activity is safe for older adults with knee pain. A comprehensive systematic review and narrative synthesis of existing literature was conducted using multiple electronic databases from inception until May 2013. Two reviewers independently screened, checked data extraction and carried out quality assessment. Inclusion criteria for study designs were randomised controlled trials (RCTs), prospective cohort studies or case control studies, which included adults of mean age over 45 years old with knee pain or osteoarthritis (OA), undertaking physical activity over at least three months and which measured a safety related outcome (adverse events, pain, physical functioning, structural OA imaging progression or progression to total knee replacement (TKR)). Of the 8614 unique references identified, 49 studies were included in the review, comprising 48 RCTs and one case control study. RCTs varied in quality and included an array of low impact therapeutic exercise interventions of varying cardiovascular intensity. There was no evidence of serious adverse events, increases in pain, decreases in physical function, progression of structural OA on imaging or increased TKR at group level. The case control study concluded that increasing levels of regular physical activity was associated with lower risk of progression to TKR. Long-term therapeutic exercise lasting three to thirty months is safe for most older adults with knee pain. This evidence supports current clinical guideline recommendations. However, most studies investigated selected, consenting older adults carrying out low impact therapeutic exercise which may affect result generalizability. PROSPERO 2014:CRD42014006913. Copyright © 2015. Published by Elsevier Ltd.
    Full-text · Article · May 2015
    • "For example, Veenhof et al. reported that only 37 of 90 (41%) and 37 of 102 (36%) knee OA patients reported to be improved after 13 weeks of following a behavioral graded activity exercise program , respectively a usual care program including exercises (Veenhof et al., 2006). Bennel et al. reported that 59% of knee OA patients indicated to be improved after 12 weeks of receiving a physiotherapy program (including exercises) (Bennell et al., 2005). A sufficiently high adherence , i.e. the number of sessions attended divided by the number of sessions prescribed, has been shown to be an important prerequisite for the exercise-induced benefits (Holden et al., 2014; Marks, 2012; Experimental Gerontology 72 (2015) 29–37 "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Exercise effectiveness is related to adherence, compliance and drop-out. The aim of this study is to investigate if exercise-induced pain and health status are related to these outcomes during two exercise programs in knee osteoarthritis patients. Methods: Symptomatic knee osteoarthritis patients were randomly allocated to a walking or strengthening program (N = 19/group). At baseline, patients were categorized according to their health status. Exercise adherence and compliance were calculated and drop-out rate was registered. For exercise-induced pain, patients rated their pain on an 11-point numeric rating scale (NRS) before and after each training session. Before each session the maximal perceived pain of the last 24 h (NRS max24) was assessed. Patients rated their global self-perceived effect (GPE) on a 7-point ordinal scale after the intervention period. Results: 53% of the participants felt they improved after the program, 6 patients dropped out. The mean adherence and compliance rates were higher than .83 in both groups. Worse health and higher exercise-induced pain were seen in drop-outs. NRS max24 during the first 3 weeks did not significantly increase compared to base-line, but correlated negatively with adherence during the home sessions (−.56, p b .05). Lower adherence during supervised sessions was significantly related with higher pre-exercise pain scores (ρ = −.35, p b .05). Conclusion: Patients who drop-out show a worse health condition and higher exercise-induced pain levels compared to patients that retained the program.
    Article · Apr 2014
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