Saw et al.

BMC Musculoskeletal Disorders (2016) 17:236

DOI 10.1186/s12891-016-1088-6

RESEARCH ARTICLE Open Access

Significant improvements in pain after a

six-week physiotherapist-led exercise and
education intervention, in patients with
osteoarthritis awaiting arthroplasty, in
South Africa: a randomised controlled trial
M. M. Saw1, T. Kruger-Jakins2, N. Edries3 and R. Parker3*

Abstract
Background: A major challenge facing those with late stage osteoarthritis is delayed surgery due to waiting lists. In
South Africa patients wait years for a hip/knee arthroplasty. Affected patients require effective management to
address their pain, especially while awaiting surgery. Existing literature is mostly available from high income
countries exploring effects of interventions during short waiting periods. Research is warranted in low income
countries where long waiting periods are common. This study explored the effects of a six-week physiotherapist-led
exercise and education intervention on pain in this population.
Methods: A randomised controlled trial was performed at two public hospitals in South Africa. Ethical approval and
informed consent was obtained. 74 participants from arthroplasty waiting lists were randomly allocated to an
intervention (n = 35) or control group (n = 39). The intervention included six physiotherapist-led group-based
sessions (two hours/week of education, exercise and relaxation). The control group received usual care. Data
collection was conducted by blinded physiotherapists at baseline, week six, 12 and month six. The primary
outcome was pain, measured by the Brief Pain Inventory. Additionally, participants completed an open-ended
questionnaire at month six, to gain insight regarding the intervention. Analysis was by intention to treat using
two-way analysis of variance and post-hoc Tukey comparisons. Answers to subjective questions were analysed
according to common themes that emerged.
Results: The intervention group had significant improvements compared with the control group with moderate
to large effect sizes (ES) on pain severity [week 6: p < 0.01, ES = 0.94, 95 % CI (0.45,1.41), month 6: p = 0.02. ES = 0.
74, 95 % CI (0.26,1.2)] and moderate to large effects on pain interference [week 6: p < 0.01, ES = 1.2, 95 % CI (0.70,1.69),
week 12: p = 0.04, ES = 0.68, 95 % CI (0.20,1.14), month 6: p < 0.01, ES = 0.98, 95 % CI (0.49,1.45)]. 53 % of participants
reported that the intervention improved their pain.
(Continued on next page)

* Correspondence: Romy.parker@uct.ac.za
3
Department of Health & Rehab Sciences, Faculty of Health Sciences,
University of Cape Town, Cape Town, South Africa
Full list of author information is available at the end of the article

© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 2 of 14

(Continued from previous page)

Conclusions: The intervention resulted in sustained significant improvements in pain severity and interference in
patients with hip/knee osteoarthritis, awaiting arthroplasty compared with a control group. Additionally, participants’
individual feedback supported observed significant improvements in pain. Such an intervention appears to be effective
in managing pain in this population and should be incorporated into practice for appropriate patients. Further research
is being conducted to explore long term and postoperative outcomes.
Clinical trial registration: Pan African Clinical Trial Registry, PACTR201409000885765, PACTR201507001186115.
Keywords: Hip/knee osteoarthritis, Arthroplasty/joint replacement, Waiting list, Physiotherapy, Exercise, Education,
Chronic pain

Background Evidence for an exercise and education intervention

Osteoarthritis (OA) is known as the most common joint It is proposed that combining first line management rec-
disease worldwide [1]. The prevalence of OA continues ommendations for OA of exercise and education could
to rise exponentially in both high and low income coun- provide a patient centred approach to ongoing manage-
tries, including South Africa (SA) [2]. The statistics from ment while awaiting arthroplasty [18, 19]. While exercise
the Global Burden of Disease studies of 2010 reported interventions alone have shown no effects on pain or
the age-standardised prevalence rates of knee OA in function in persons awaiting total knee replacement [20]
Southern Sub Saharan Africa to be 3.1 % [95 % confi- and only low to moderate effects on those awaiting total
dence interval (CI) 2.1, 4.5] in males and 5.2 % (95 % CI hip replacement [20, 21], education and exercise deliv-
3.5, 7.4) in females, with lower prevalence for those with ered by programmes such as the ESCAPE programme
hip OA (males: 0.6 %, 95 % CI 0.5, 0.7. Females: 0.8 %, [22] and/or arthritis self-management programme [23]
(95 % CI 0.6, 0.9) [2]. This increasing prevalence is par- have been reported to be an effective method of not only
tlydue to an increasingly aged population, decreased improving knowledge, but also prolonging the belief that
physical activity and obesity [2–4]. The burden of OA exercise is beneficial and achieving desired changes in
leads to a large portion of the older population suffer- exercise habits [22]. Asevidence suggests, instead of
ing with severe pain on a daily basis [5, 6]. Due to the merely educating on the importance of exercise, inter-
chronicity and complexity of OA, effective manage- ventions should include both educational and active par-
ment is necessary at all stages of the condition to ticipatory exercise components [23, 24]. To further
manage this population’s pain. expand on this it is anticipated that by combining both
As insight into this field of research is constantly- aspects, the optimal benefits of these two management
improving, many evidence-based guidelines have been- options could be achieved by allowing the person to in-
published for the management of hip and knee OA corporate new knowledge from the educational compo-
[7–14]. The evidence-based management for OA be- nent into practice and implement the advised changes in
gins with non-pharmacological methods of education, beliefs and behaviours, such as exercise, in order to ex-
exercise and weight control. Pharmacological agents perience the benefits first hand [22–27]. Previous studies
are subsequently added as required, in combination have shown benefits from various exercise and education
with the above first-line management. Finally, surgery interventions in persons with hip and knee OA; ranging
is indicated for those with late stage OA who do not from improvements in pain [24, 28–30], function [24,
respond to conservative treatment methods [13, 14]. 28–31], self-efficacy [28, 29, 32, 33], and exercise partici-
A major concern internationally is the limited accessi- pation [28, 33]. Despite literature supporting the use of
bility of the recommended management options, espe- combined interventions in persons with OA, studies spe-
cially in the public health system [4]. This is true for cific to those with severe OA and awaiting surgery for
many individuals in SA where first line management op- extended periods such as the population in SA, are
tions are not readily accessible and delays in surgery are scarce.
experienced as a result of long waiting lists [15]. To the authors’ knowledge, no such studies have been
Waiting lists in secondary and tertiary health facilities performed in the SA population and the above men-
in SA have been reported to range from one to eight tioned studies performed in higher income countries
years depending on the severity of the condition and the with more accessible resources and shorter waiting times
resources available [15]. Waiting for surgery for six cannot be generalised to the SA population.
month or longer is reported to have various negative- Therefore, in response to the increasing burden of OA
impacts on the individual including worse pain, function and long waiting lists for hip and knee arthroplasty in
and quality of life, adding to the burden of OA [16, 17]. the public health system in SA, research was warranted
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 3 of 14

to establish the effects of a pre-operative exercise and large effect size (ES > 0.5) accepted as meaningful. It was
education intervention on pain, for patients with OA calculated that samples of 26, 36, and 45 participants in
awaiting arthroplasty. Additionally, we aimed to establish total would provide 80 %, 90 % and 95 % statistical
whether any changes in pain were supported by individ- power for change in pain respectively.
ual responses when interviewed about participating in To allow for attrition at recruitment or during the
the intervention… study, a higher target sample size was preferred and re-
cruitment was aimed at a maximum of 48 participants at
Methods each site to make up 2 groups of 24 (a maximum of 96
Study design participants across both sites).
A randomised controlled trial was performed and is
reported according to CONSORT (Consolidation of Recruitment procedure
Standards of Reporting Trials) guidelines. The waiting lists at both facilities combined were-
approximately 4300 patients requiring arthroplasty for
Ethical Approval various reasons, including OA. Due to limited research
The University of Cape Town Human Research and Ethics personnel in the public health setting in SA and not-
Committee granted approval for this study (Ref 378-2013, being able to contact all patients, a random sample of
492-2013). The clinical trial was registered with the Pan 20 % of the total waiting list (n = 781) was drawn for-
African Clinical Trial Registry (PACTR201409000885765, logistical reasons, using random number selection in
PACTR201507001186115). Microsoft Excel. This was done to ensure patients had a
fairer chance of being contacted, rather than contacting
Participants patients from the top of the list down. Diagnosis was
The population of interest was patients diagnosed with made by the orthopaedic surgeon at the first clinic visit
OA in SA. The sampling frame included patients who when the patient was placed on the waiting list from
had been placed on a waiting list to receive a hip/knee clinical history, physical examination and radiographic
arthroplasty, specifically in the public health system images according to American College of Rheumatology
inthe Western Cape and Gauteng provinces. Principle (ACR) clinical and radiological criteria. Those in the
investigators were given access to waiting lists at sample that met inclusion criteria were contacted tele-
Tygerberg and Helen Joseph Hospital. Participants phonically by the primary investigators, to inform them
were required to be on the waiting list for a minimu- of the nature of the study and to invite them to partici-
mof three months to allow for necessary stabilisation to pate, if eligible. A large number of participants (n = 685)
any new medications that may have been prescribed or were unreachable and/or excluded from participating for
adjustments to their treatment when the patient was first various reason such as incorrect age/diagnosis other
put onto the list. Inclusion criteria were as follows: a will- than OA according to the waiting list information, previ-
ingness to commit to the study, aged between 50 – ous surgery, not interested, transport issues (Fig. 1).
70 years, diagnosed with OA of the hip/knee, literate in Thus 96 participants were invited to attend baseline test-
English,Afrikaans, isiXhosa or isiZulu. Exclusion criteria ing, 21 did not arrive due to losing interest or transport
were any cognitive impairment, as reported in the medical issues and 1 was excluded due to incorrect diagnosis,
records, previous trauma/surgery to the unaffected leg, therefore 74 arrived and were eligible to partake.
deemednot eligible for exercise as per the American The first 10 participants’ baseline meeting was utilised
College of Sports Medicine (ACSM) guidelines for ex- to pilot the baseline procedures of providing all relevant
ercise prescription. Reasons for exclusion according to information to the participants, obtaining informed-
theACSM included previous cardiac conditions or surger- consent, completing demographic information and com-
y,uncontrolled diabetes or asthma [34]. Additionally pleting baseline outcome measures.
those who had previously taken part in a six-week This took place at the setting intended for the study
programme aimed at improving self-efficacy and man- where outcome measures and the intervention took
agement were excluded. place, with the presence of the principle investigator for
Since pain was the primary outcome measure in this the information and informed consent signing and the
study; a change in pain severity was selected to deter- blinded physiotherapist research assistant (RA) for com-
mine the required sample size using Brief Pain Inventory pleting the outcome measures, at each hospital. Piloting
(BPI) data from a previous study on pain in people with went smoothly as participants were able to complete
OA [35]. Calculations used a smallest meaningful differ- outcome measures with the assistance of the RA without
ence in pain scores of 3 (on a scale of 0 to 10 on the issues, it was noted that the time allocated to each-
BPI), and a standard deviation of 2.49 [35]. Statistical session of data collection was sufficient and no changes
significance was accepted as p < 0.05 with a medium to were needed to the methods of collecting data for
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 4 of 14

Fig. 1 Recruitment and randomisation process

theprimary outcome measure. Thereafter, the remaining primary doctor, while awaiting surgery. The experimen-
64 participants gave written informed consent anddemo- tal group (n = 35) were contacted telephonically and
graphic information (including age, gender, educational were requested to begin the six-week education and-
level, employment status, joints affected, BMI, co- exercise intervention commencing the following week
morbidities and waiting time for surgery) was recorded (Fig. 1). Follow up measures were taken at week six-
with the help of the research assistant. The participants following the intervention, and again at week 12 and
completed the outcome measures, assisted by the research month six, which concluded the study (Fig. 2).
assistant with a translator where necessary.
The participants were stratified, according to OA of Intervention
the hip or knee and then randomly assigned into either It was proposed that this intervention has the potential to
the experimental or control group, by means of random manage, yet probably not cure pain in this chronic condi-
number allocation. This was performed by the two- tion, as it is based on the International Classification of
primary investigators. Those selected for the control Functioning, Disability and Health’s (ICF) understanding
group (n = 39) were contacted telephonically in the week of health [26, 33]. This framework targets physiologicalim-
that followed baseline assessment and were instructed to pairments (pain, muscle weakness, joint stiffness, and
continue receiving their usual care, determined by their low fitness levels), personal factors (knowledge, health
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 5 of 14

Fig. 2 Data collection process

beliefs, self-efficacy, and stress management) and be- the six sessions to ensure content and delivery of the
haviours during daily activities (avoidance of movement intervention remained constant. It took place for a max-
or exercise, eating and sleeping habits, goal setting) [26, imum of two hours, on a weekly basis for six successive
33]. The intervention comprised of a six week weeks, in groups of no more than 12 participants. Each
physiotherapist-led education and exercise programme two hour session included an educational component of
which was developed from previously used programmes approximately an hour, an exercise component of 20 to
[25, 33, 35–38]. 30 min and a relaxation session of 10 min.
This multi-faceted approach addresses the participant
holistically by means of education (including pain neuro- Educational component
science education), self-management strategies and an The educational topics covered are outlined in Table 1.
active exercise component. The intervention approach The model of delivery of this intervention is based on the
and content allows for accommodation of participants principles of social learning and cognitive behavioural-
with OA of both hip and knee. The intervention took approaches [25, 27, 32, 39, 40]. The educational component
place in an out-patient setting at both hospitals and was aimed at increasing knowledge and understanding of
wasled by the principle investigators, two qualified physio- OA, pain neuroscience, activity and related topics affected
therapists who had been trained in the respected field and by their condition. Important topics such as self-
who could deliver the programme in both English and- management skills, problem solving, goal setting, coping
Afrikaans. IsiXhosa and isiZulu translators were present mechanisms, stress management, and pacing were dis-
for intervention sessions. The same physiotherapists led cussed to enable the participant in self-management [27].

Table 1 Educational content covered on a weekly basis during the intervention

Topic for the week Content covered
Week 1: Osteoarthritis, self-management and exercise Pathology of OA. What is meant by “self-management”? Self-management steps.
Action plans, goal setting. Exercise dos and don’ts. Types of exercise, steps to
success with exercise. An exercise routine.
Week 2: Managing common symptoms Physiology of acute and chronic pain. Pain and flare ups of pain. Swelling.
Joint protection, assistive devices. Pacing and activity/resting cycles.
Fatigue, frustration, isolation.
Week 3: Stress management What is stress? Managing stress. Sleep management. Communication with
your health carer. Relaxation skills.
Week 4: Eating well Balanced nutrition. Dealing with barriers to eating well. Food safety,
weight loss benefits.
Week 5: Medication and disease related problem solving Making informed treatment decisions. Appropriate use of medications.
Link between a healthy lifestyle, good nutrition and exercise. Communicating
effectively with family, friends, and health professionals with regards
to your problems.
Week 6: Continuing as a successful self-manager Recap of key components of successful self-managing, Action planning for
the future. Reflection on changes.
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 6 of 14

Each participant received a “Living with Osteoarthritis” Trials (IMMPACT) panel, which should be included in all
workbook (in their preferred language) on the content of research dealing with chronic pain evaluation [46, 47].
each educational session, which they were encouraged to Psychometric testing has been performed on the BPI’s
work through each week [41]. use in OA [35, 48] and its’ use in the assessment of pain
to distinctly depict pain intensity and its effects on func-
Exercise component tion is supported [49–51]. The BPI has high levels of tes-
The exercise component allowed participants to apply tre-test reliability [35, 52–54] and internal consistency
what was learnt into actual behaviour changes [27]. It in various languages and does not display cultural
comprised of various stretching, light aerobic exercise bias [55, 56]. Of particular interest to this study, the
and different lower limb muscle group strengthening- BPI has been used in studies of OA which reported
exercises [31]. Participants were required to set exercise good internal consistencies; particularly for the sub-
and activity goals on a weekly basis and to record the- scale of pain interference [57, 58].
sein their workbooks. The exercise component com- The BPI has previously been translated into Afrikaans
menced at low repetitions and intensity and was [59] as well as isiXhosa [40]. The IMMPACT panel has
progressed weekly from 20 min in duration, increasing specifically singled out the pain interference scale from
time by 10 % andintensity as appropriate, depending on the BPI as a recommended scale to use for assessment
each participant’s individual ability. As the group size was of pain-related functional impairment [60].
small, safetyduring exercise and appropriate progression Besides the BPI, secondary measures of disability [Health
was possible despite being in a group [23]. The detailed Assessment Questionnaire (HAQ)] [61], function (The
exercise programme is described in detail (see Table 1). Physical Performance Task Battery) [62], self-efficacy (The
The intervention concluded with a relaxation session led Self-Efficacy for Managing Chronic Disease 6-Item Scale)
by the physiotherapist facilitating various relaxation visua- [63] and health related quality of life (EQ-5D) [64] were
lisations, an example of which is included in the work- taken at all follow up intervals (Fig. 2).
book. Although relaxation techniques are not included in In addition, the experimental group were asked to
the recommended management of OA, it is widely used complete an open ended questionnaire at the six month
in chronic pain conditions and is seen as a helpful self- follow up meeting. A simple questionnaire was con-
management skill [42, 43]. structed by the principle investigators to include seven
Attendance for the intervention was recorded and open ended questions about the six-week intervention
monitored weekly. If a participant was absent for a- and workbook used. This questionnaire did not go
session of the intervention, the participant was contacted through any process of validation. The questions are in-
telephonically and asked the reason for absenteeism and cluded in the Additional file 1. This was to gain some
encouraged to attend the next session. The intervention insight into the participants’ personal thoughts or feel-
took place as described above for six weeks. ings around the intervention and the individual effects
thereof.
Instrumentation
The primary outcome measure was pain as measured by Statistical analysis
BPI [44]. The BPI is a short self-administered assessment The primary outcome measure of pain severity accord-
tool for measuring the severity of pain and the effects ing to the BPI at baseline showed that data werenormally
thereof (out of 10) and is widely used in both clinical distributed [Week 0 BPI severity: N = 74, K-S p value >
and research environments [45]. To address shortcom- 0.20 (K-S p > 0.05)]. Therefore parametric statistics were
ings found with other pain scales that neglect pain’s used in the numerical analysis and Pearson Chi-squared
characteristic as a variable factor, the BPI evaluates pain (χ2) calculations were used for categorical data. However,
severity on the person’s “worst”, “least”, “average” and waiting time was not normally distributed therefore
“now” pain over the last 24 h instead of one score for- non-parametric analysis was conducted and the Mann–
intensity of pain during different tasks. A pain severity Whitney U test was used for thesecalculations. Data was
score is calculated as an average of these four scores.Pain analysed using Statistica software(StatSoft, Inc. 2004.
interference is scored by evaluating the effect of pain on STATISTICA, Data Analysis Software System, Version
an activity sub-dimension (walking, generalactivity and 10. www.statsoft.com).
work) and four other aspects of life (relationships with Statistical significance for the two main effects of group-
others, enjoyment of life, mood, forming the affective sub and time, and the interaction (group x time) for the
dimension, and sleep) [45] (see Additional file 1 for the BPI was assessed using a two-way analysis of variance
BPI). These two dimensions (severity and functioning) are (ANOVA) with repeated measures. Tukey’s post hoc
the first two dimensions, described by the Initiative on comparisons were performed where necessary to de-
Methods, Measurement, and Pain Assessment in Clinical termine significance between groups at different time
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 7 of 14

periods. Analysis was by intention to treat. Missing- 32 with knee OA and 12 with both hip and knee OA. It
data was managed by carrying forward the last observed was observed that the sample had a large number of co-
measurement. All numerical data was presented as the morbidities present, with an average of 1.28 per partici-
mean (M) ± standard deviation (SD). Statistical signifi- pant.The most common condition present was hyper-
cance was accepted as p < 0.05. Effect sizes (ES) were- tension (n = 29) as well as hypertension with
calculated and reported on with 95 % CI where diabetesmellitus (n = 13). Median waiting time for surgery
appropriate when there were significant differences be- when the study commenced was 1 years and 11 months,
tween groups. Effect size was calculated as Cohen’s d [65] with a range of the shortest time on the waiting list being
using the following formula: 3 months and the longest being 11 years. There were no
significant differences between groups at baseline for time
experimental mean change − control mean change on the waiting list (U = 560.5, p = 0.18) or for BMI, joints
ES ¼ :
pooled baseline SD affected or co-morbidities present (p > 0.05). According to
baseline data, 40 participants were using analgesics, 28
Finally, a descriptive thematic analysis using an induct- were using analgesics and anti-inflammatories and six
ive approach was used to identify common themes from were not taking medication for pain relief; with the mean
the answers to the open-ended questions. These themes percentage pain relief obtained from medication at
were created to foster better understanding of the- 47.92 %, SD = 25.56 %. According to the BPI, there were
responses to the questions related to the intervention. no significant differences in percentage pain relief ob-
tained from medication between groups throughout the
Results study [current effect: F(3, 177) = 0.63926, p = 0.59].
Results are presented throughout for the entire sample
(N = 74); the experimental group (n = 35) and the control Pain severity score
group (n = 39). For the purposes of this manuscript no At baseline, the pain severity scores demonstratedmo-
sub group analysis, according to OA hip or knee, have derate to severe pain in the whole sample (M = 6.53, SD =
been reported on. The mean age for the sample was 2.29) (Table 2). Those who participated in the intervention
60.72 years, SD = 5.54. The sample consisted of 14 males group (IG) showed significant improvements in pain se-
and 60 females, most of which (n = 59) were unemploye- verity when compared to the control group (CG)with
d(receiving a pension or disability grant). Varied educa- moderate to large effect sizes [current effect: F(3,
tional levels were noted; many participants had low levels 216) = 8.904, p < 0.01]. This was seen at week 6 by
of education of no higher than grade 7 (n = 16), with the between-group differences of: M = 2.44, SD = 2.24, p <
majority having an educational level between grade 8 – 11 0.01, ES = 0.94, 95 % CI (0.45, 1.41)] and at month 6:
(n = 43). There were no significant differences between M = 2.24, SD = 2.39, p = 0.02, ES = 0.74, 95 % CI (0.26,
groups at baseline (p > 0.05) for age, gender, employment 1.2) (Table 2 and Fig. 3).
status or education.
The sample had a very high mean body mass index Pain interference score
(BMI) value of 34.46, SD = 8.23 which is classified as class I Similarly, at baseline the sample had moderate to severe
obesity [66]. There were 30 participants who had hip OA, scores for pain interference (M = 6.23, SD = 2.25) (Table 2).
Table 2 Brief Pain Inventory scores
Experimental Group Control Group Between-group difference over time
n = 35 n = 39
Mean ± SD (out of 10) Mean ± SD (out of 10) Mean (95 % CI), ES (95 % CI)
Baseline 6.71 ± 2.32 6.37 ± 2.16
Severity 6.75 ± 2.41 6.44 ± 2.11
Interference
Week 6 3.99 ± 2.44* 6.09 ± 2.02 2.44(0.6, 4.3), ES = 0.94(0.45, 1.41)
Severity 3.13 ± 2.32** 5.77 ± 2.07 2.95(0.73, 5.2), ES = 1.2(0.7, 1.69)
Interference
Week 12 4.34 ± 2.86 6.05 ± 2.34 2.05(0.51, 3.6), ES = 0.66(0.18, 1.12)
Severity 4.23 ± 2.72** 5.95 ± 2.35 2.03(0.5, 3.6), ES = 0.68(0.2, 1.14)
Interference
Month 6 4.49 ± 2.85* 6.39 ± 2.30 2.24(0.55, 3.9), ES = 0.74(0.26, 1.2)
Severity 3.60 ± 2.63** 5.98 ± 2.24 2.69(0.66, 4.7), ES = 0.98(0.49, 1.45)
Interference
*indicates a significant improvement in pain severity of the experimental group compared to control group
**indicates a significant improvement in pain interference of the experimental compared to control group
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 8 of 14

Fig. 3 Pain severity score (N = 74)

Likewise, those who participated in the intervention group 0.04,ES = 0.68, 95 % CI (0.2, 1.14)] and month 6 M =
showed significant improvements in pain interference 2.69, SD = 2.18, p < 0.01, ES = 0.98, 95 % CI (0.49,
with moderate to large effect sizes when compared to the 1.45) (Table 2 and Fig. 4).
control group [Current effect: F(3, 216) = 6.85, p < 0.01].
This was observed at all intervals by mean between-group Open-ended questionnaire
differences: week 6 M = 2.95, SD = 2.23, p < 0.01, ES = 1.2, Responses from 30 participants of the experimental group
95 % CI (0.7, 1.69)], week 12 M = 2.03, SD = 2.41, p = were collected as five did not complete this questionnaire.

Fig. 4 Pain interference score (N = 74)

Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 9 of 14

Themes were identified by analysing answers to questions whencompared to the control group (Current effect:
one, two and five. The four themes that emerged were: F(3, 216) = 4.37, p < 0.01). This difference was ob-
pain relief, increased knowledge, improvement in func- served at week six by between group differences of
tion/activity, and personal/social benefits. Since this arti- M = 1.72, SD = 1.51, p = 0.03, ES = 0.76, 95 % CI (0.28,
cle’s main focus is on the effects of the intervention on 1.22) (Table 4). No other significant differences were
pain, the answers relating to pain were analysed. Table 3 noted at other time intervals.
presents the answers given by participants showing the Health related quality of life of the sample at baseline was
benefits experienced related to their pain. low (M = 0.37, SD = 0.33). The intervention group showed
Adverse responses were also noted in responses. One a significant improvement in HRQoL when compared to
participant stated that although the intervention had been the control group (current effect: F(3, 216) = 4.45, p < 0.01).
very helpful, the effect on her pain did not last. Another This difference was seen at week 12 by between group-
participant responded that accessibility had been a prob- differences of M = 0.26, SD = 0.58 p = 0.03, ES = 0.71, 95 %
lem as elevators were not always operating well and CI (0.24, 1.18) (Table 4). No significant differences were-
wheelchairs were not readily available. The answers to the recorded for EQ5D health state at any time point (Current
other four questions have not been included in this article effect: F(3, 216) = 2.47, p > 0.05).
as the majority of participants agreed in their answers in Disability according to the HAQ disability index (DI) at
that there was nothing they did not like or nothing else baseline illustrated a moderate level of disability (M = 1.12,
that needed to be added to the intervention or workbook. SD = 0.69). No significant differences were observed be-
tween groups for the DI during the study (Current effect:
Secondary measures F(3, 216) = 8.51, p < 0.01) or for the HAQ pain visual
Self efficacy at baseline showed a mean score of 5.88 out analogue scale (VAS) during the study (Current effect: F(3,
of 10, SD = 2.38. Those who participated in the interven- 120) = 5.97, p < 0.01). Additionally, there were no significant
tion demonstrated a significant improvement in SE differences between groups in any of the tests from the
physical performance task battery (normal walk, fastest
Table 3 Subjective responses related to pain (N = 30) 15 m test, six minute walk test, forward reach, upward
Examples of the experimental group’s answers to open ended questions reach, sock test and sit to stand). Further information on
one – five secondary measures is available from the authors.
Question 1: Did you find the 6 week course helpful to you in any way? Of the entire sample, 10 % were absent at week six-
If so how did it help you? follow up; six from the control group and two from the
Participant V: “All the pain was gone” intervention group. At week 12, a higher attrition rate
Participant A: “Much better with pain and sometimes without pain.” was seen with 23 % of the sample being absent for follow
Participant N: “Yes, pain relief.”
Participant R:”…and now I don’t have to rely on pain pills anymore.”
up measures; 12 from the control and six from the-
Participant AA: “it gave me motivation again because my life was all experimental group. At month six, a further 2 % of the
about pain before. Now I use my workbook and it helps a lot” sample was absent at follow up measures; nine from the
Participant CC: “…and it decreased my pain.”
Participant XX: “…and to decrease pain.”
experimental group and ten from the control group. See
Participant 36: “Yes the course was very helpful, but I am in pain Table 5 for details.
again – then it was better, but not so much now” The results of this study presented here support the use
Participant 31: “Yes. I learned so much about my pain and how I can
make changes for myself and make the pain better”
of a six-weekphysiotherapist-led exercise and education
Participant 11: “It was very helpful…I slept better and had no programme to improve pain, in patients with osteoarth-
cramps – everything was much better.” ritis of the hip and/or knee awaiting arthroplasty. This is
Participant 9: “Absolutely 100 %. I got a lot of relief from my pain…”
Participant 7: “My God – everything has changed. I don’t need operation
seen by clinically relevant findings in the experimental
anymore, I can work without pain…it takes my pain away – most of group with significant improvements in pain severity and
the time.” interference with moderate to large effect sizes, when
Participant 47: “…It helped me to manage my pain…”
compared to the control group.
Question 2: What did you like about the course?
Participant S: “I learnt how to put ice on my knee to relieve the pain.” Discussion
Participant WW: “how to be more positive and to control pain.” As pain is the most common complaint of those suffer-
Participant 5: “…learning about pain and what I can do to make it better.”
ing with OA [67, 68], most studies performed in this
Question 5: What did you like about the workbook?
field assess pain severity. In this study, the BPI shows an
Participant R: “…also the section about pain management and not exercise and education intervention can result in a-
having to rely on pills”
Participant 31: “Teaches us how to take care of ourselves, not to depend moderate effect on pain; as seen by the sustained signifi-
on medication…” cant reduction in pain severity scores over time. It is
Participant 35: “That it could teach me things about pain and healthy noted that the changes in pain severity between groups
living - I still read in it.”
approach what is considered a meaningful difference in
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 10 of 14

Table 4 Secondary outcome scores

Experimental Group Control Group Between-group difference over time
n = 35 n = 39
Mean ± SD (out of 10) Mean ± SD (out of 10) Mean (95 % CI), ES (95 % CI)
Baseline 5.83 ± 2.57 5.92 ± 2.24
Self-efficacy 0.36 ± 0.34 0.38 ± 0.32
HRQoL
Week 6 7.36 ± 2.33* 5.73 ± 1.96 1.72(0.42, 3.0), ES = 0.76(0.28, 1.22)
Self-efficacy 0.65 ± 0.31 0.44 ± 0.30 0.23(0.6, 0.4), ES = 0.69(0.21, 1.15)
HRQoL
Week 12 6.95 ± 2.30 5.51 ± 2.00 1.53 (0.38, 2.7), ES = 0.67(0.3, 1.13)
Self-efficacy 0.60 ± 0.32** 0.36 ± 0.35 0.26(0.06, 0.46), ES = 0.71(0.24, 1.18)
HRQoL
Month 6 7.19 ± 2.12 6.00 ± 1.93 1.28(0.32, 2.2), ES = 0.59(0.12, 1.05)
Self-efficacy 0.55 ± 0.34 0.37 ± 0.34 0.2(0.05, 0.35), ES = 0.53(0.06, 0.99)
HRQoL
*indicates a significant improvement in SE of the experimental group compared to control group
**indicates a significant improvement in HRQoL of the experimental compared to control group

pain (3 on a scale of 0 – 10). The intervention’s reported whereas the upper limit (1.41 and 1.2) are seen as very
mean effect size on pain (ES 0.94 and 0.74 at week 6 and large effects. Thus these results for pain severity should
month 6 respectively) is larger than previous studies be interpreted with a degree of caution.
reporting the effects of exercise alone on pain in persons Elsewhere, effect sizes for pain severity in prior studies
with OA (ES 0.39 – 0.58) [69–72]. Fransen and col- on similar integrated interventions in knee OA range
leagues similarly reported a large ES for pain after an ex- from 0.2 to 0.27 [30, 73]. A study of integrated exercise
ercise intervention in persons with knee OA (ES = 0.94, and education by Lamb et al. [29] is more in line with
p < 0.01) yet combined data for hip and knee OA show the longer waiting periods (over a year) experienced in
small to moderate effect with a smaller effect at its lower the SA population and is supported by the current
CI (ES 0.46, 95 % Cl (0.35, 0.57) [71]. This is better study’s findings. Lamb et al. showed moderate effect
matched to the lower confidence interval noted in the sizes for pain improvement are attainable in those with
current study for reduction in pain severity. However, knee OA in patients with symptoms on average of
comparison to Fransen et al.s’ study on exercise should 10 years [29]. However, their study did not make use of
be made with caution as they only followed their partici- a control group which highlights a strength of the
pants for four months [71]. current study’s design.
It is important to consider the precision of the re- For a chronic pain condition such as OA, it is not only
ported effect size in this current study when interpreting how much pain one has but the debilitating effect that
results as the CI of 0.45 – 1.41 and 0.26 – 1.2 at week pain has on the person’s daily life and interactions that
six and month six show a considerable difference in- requires attention [74]. An intervention including self-
confidence limits. The lower limit (0.45 and 0.26) of the management strategies, such as the present intervention,
effect size for changes seen in pain severity at week six with a focus on the effect of pain rather than just the
and month six report a small to moderate effect at most amount of pain is recommended [74]. Previous research

Table 5 Attrition rate details

Week 6 Week 12 Month 12
Reason for absence Experimental Control Experimental Control Experimental Control
Withdrawing from study 1 1 2 2 2 2
Falling ill 1 2 2 1 3 1
Forgetting 3 4 3
Transport 1 2
Receiving surgery 1 2 3 2
Work responsibility 2
Other: funeral 1
Total 2 6 6 11 9 10
Percentage of entire sample 10 % 23 % 25 %
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 11 of 14

has shown the debilitating effects of pain from being on in pain levels and interference since commencement of
relatively short waiting lists (less than 12 months); with the study. However this finding should also be inter-
worse pain and effects on function being correlated to preted with caution as correlation calculations were not
longer periods of waiting [75, 76]. As a result of this performed to confirm this. Similarly as mentioned above,
sample’s long waiting period (average of two years, six even though the ES is moderate, the CI limits are again
months), it was anticipated that this group would very wide (0.24, 1.18) and this significant difference is
present at baseline with severe interference in physical not consistent at week six or sustained at month six.
and emotional functioning as a result of pain (M = 6.23, The findings of no improvements in disability or func-
SD = 2.25). Despite this, the findings show that the inter- tion are not necessarily surprising in this sample awaiting
vention can significantly reduce and sustain lower pain surgery with moderate to high levels of disability at base-
interference scores. line. It is anticipated that a more meaningful improvement
Again, the large mean effects in pain interference,- in pain severity and interference could possibly translate
particularly at week six (ES = 1.2, 95 % CI, 0.7, 1.69) and into improvements in these areas and further research
month six (ES = 0.98, 95 % CI, 0.49, 1.45), are notably could confirm this hypothesis.
better than the ES of pharmacological agents such as Since the wait for surgery is so lengthy in the public
NSAIDS (ES = 0.32, 95 % CI 0.24, 0.39) and acetamino- health sector in SA, the benefits recorded after this short
phen (ES =0.21, 95 % CI, 0.02, 0.41) for pain in people intervention are encouraging and support the previously
with OA [77]. Both NSAIDs and analgesics are pre- identified need to improve pain and related function in
scribed to most, if not all, patients on a waiting list as those whose waiting period is longer than a year [22].
part of the first-line management of OA despite small The current study appears to have begun to meet this
ES [9]. Furthermore, the ES of the combined treatment need by reducing pain severity and interference while
of exercise and education used in this study on pain awaiting surgery after just six weeks of an exercise and
interference was again larger than the ES on pain in hip education intervention. This is in contrast to other-
and knee OA for aerobic exercise alone (ES = 0.52, 95 % studies which report benefits to be evident only after a
CI, 0.34, 0.70), strength exercise alone (ES = 0.32, 95 % longer period of time [23, 78]. Despite the current study
CI, 0.23, 0.42), water-based exercise alone (ES = 0.25, following participants for shorter than the recommended
95 % CI, 0.02, 0.47) or education or self- duration of 12 months, the results are considered as a
managementinterventions alone (ES = 0.06, 95 % CI, positive contribution towards further research in this
0.02, 0.10) [77]. Therefore, it can be said that the effects field as improvements in pain severity and particularly
of change for pain interference are of a higher precision pain interference were observed after only six weeks and
than thosereported for pain severity with the differences sustained at month six.
in CI limits being smaller, particularly for pain interfer-
ence atweek 6. The large and more precise effect of the Strengths/limitations
combined intervention seen in this study for pain interfer- A moderate sample was recruited from two different
ence appear more accurate and may be considered a more regions of the country, servicing two populations with
effective treatment strategy for these patients than osteoarthritis. This allows for a limited degree of
pharmacological agents or individual treatment generalizability to the broader population of OA sufferer-
approaches. sawaiting a joint replacement, in the SA public health
The individual answers grouped together formed system. However, it is important to note that over
themes which was helpful to link the benefits observed 90 % of those on the waiting lists were not included
in pain scores over time with responses given relating to in the study for different reasons (Fig. 1). This is a
pain relief. Many (53 %) of the participants’ responses to potential source of recruitment bias. Those not in-
the questionnaire supported the significant improvement cluded in the study for unspecified reasons may have
in pain scores seen across the sample. been either (a) too ill to participate or (b) not experi-
The participants’ improved self efficacy after six weeks encing sufficient pain to be motivated to participate.
shows that the intervention may have resulted in im- If the majority of unspecified non-participants fell
proved self-belief in their ability to achieve goals or- into either of these categories, the results may be
perform an activity. However, the ES is moderate and biased. Another aspect is that this sample had slightly
the significant difference between groups is quite small low educational levels compared to those in upper-
(M = 1.72, SD = 1.51) with a wide CI limit (0.28, 1.22) income countries; which is representative of the large
and the effect is not sustained beyond six weeks. This portion of the previously disadvantaged population,
finding should be interpreted with caution. who consequently also have low income levels and
The significant improvement in HRQoL at week 12 therefore attend public health facilities [79]. Caution
may be interpreted as a consequence of improvements should be applied as these findings might not be
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 12 of 14

transferable to those in the private health sector who Additional file

may have higher educational levels or wait shorter-
periods for surgery. Additional file 1: “Appendix” includes examples of the exercise
component of the intervention, the Brief Pain Inventory, open-ended
Although the use of medication and percentage pain- questionnaire, secondary measures and the CONSORT guidelines table.
relief obtained from medication was recorded on the BPI, (DOCX 115 kb)
specific use of medication in terms of type, dose or how
often medication was used was not recorded. This could Abbreviations
be valuable data to determine whether the intervention- ACR, American College of Rheumatology; ACSM, American College of Sports
Medicine; ANOVA, analysis of variance; BMI, body mass index; BPI, brief pain
affected the use of medication or whether medication use inventory; CI, confidence interval; CONSORT, Consolidation of Standards
influenced how participants responded to the interven- of Reporting Trials; DI, disability index; ES, effect size; ESCAPE, enabling
tion. It is recommended that future research into this field self-management and coping with arthritic knee pain through exercise;
HAQ, health assessment questionnaire; ICF, International Classification of
should consider medication use and effects thereof. Functioning, Disability and Health; IMMPACT, initiative on methods,
As Hurley and colleagues state, loss to follow up is a measurement, and pain assessment in clinical trials; OA, osteoarthritis;
common problem during research [32]. This was not too SA, South Africa; VAS, visual analogue scale
concerning at the first follow up session as seen by only
Acknowledgements
10 % loss to follow up, however higher attrition rates at Funding received from South African Society of Physiotherapy, Margaret
week 12 (23 %) and month 6 (25 %) should be consid- Roper Scholarship and UCT PG funding. To the staff, research assistants,
ered during interpretation of the findings. To manage translators and patients who made research possible at Tygerberg and Helen
Joseph Hospital.
missing data, data was carried forward from the last-
observed measure. This may have led to blunting of- Availability of data and materials
results and therefore it is recommended that for future The authors are unable to share raw data because ethical approval was not
obtained for data sharing of this nature. In addition, informed consent for
studies researchers explore a different approach such as data sharing was not obtained from individual participants. Supporting data
“multilevel modeling and multiple imputation to gener- is available in print from UCT libraries: Full dissertation “The effects of a
ate robust predictions of the effect of missing data” [80]. six-week physiotherapist-led exercise and education intervention in patients
with osteoarthritis, awaiting an arthroplasty in South Africa.” by MM Saw
Despite the risk of further loss to follow up, it is recom- SWXMEL001 and “The effects of a six-weekphysiotherapist-led exercise and
mended that future trials extend the follow up period to education intervention in patients with Osteoarthritis awaiting arthroplasty in
at least 12 months as long lasting benefits are especially Gauteng” by TK-J KRGTIN001.
needed in persons on a long surgical waiting list [24]. Authors’ contributions
Another study is currently underway to extend follow MS identified the need for the study and made substantial contributions to
up duration which will provide valuable comparative conception and design of the study; was the primary investigator and
responsible for the study being completed at Tygerberg hospital, including
data whereby the current findings can be compared with recruitment of patients and running the intervention; was involved in data
prior long term research concerning persons with OA collection, analysis and interpretation of data and primarily drafted the
awaiting arthroplasty as well as post-operatively. In manuscript. TK-J made substantial contributions to design of the study; was
the primary investigator and responsible for the study being completed at
addition to this, it is suggested that future research- Helen Joseph hospital, including recruitment of patients and running the
evaluates whether such an intervention has different- intervention; was involved in data collection, analysis and interpretation of
effects on those with OA of the knee or hip, and/or any data and assisted in critically revising the manuscript. NE made contributions
to design of the study, was the co-supervisor of the study and assisted in
effect on the need to still be on a waiting list for surgery. critically revising the manuscript. RP made substantial contributions to-
conception and design and coordination of the study; was the primarysuper-
Conclusion visor of the study, was involved in data analysis and interpretation of
data and assisted in critically revising the manuscript. All authors read
The rationale behind undertaking the present study was and gave final approval of the version to be published, agree to
primarily due to the rising burden of osteoarthritis affect- beaccountable for all aspects of the work in ensuring that questions
ing thousands of individuals awaiting surgery in South- related to the accuracy or integrity of any part of the work are-
appropriately investigated and resolved.
Africa. This study provides evidence for an acceptable and
effective evidence-based short term non-pharmacological Competing interests
and non-surgical intervention that can be easily delivered The authors declare that they have no competing interests.
by a physiotherapist. The intervention appears to be-
Ethical approval and consent to participate/publish
effective in reducing this population’s suffering by redu- The University of Cape Town Human Research and Ethics Committee
cing pain severity and interference and is well received by granted approval for this study (Ref 378-2013, 492-2013). Informed consent
patients. Further research into this population of interest documents were signed by all participants included in the study, including
information for intent to publish data.
will be of value in determining longer lasting effects while
awaiting surgery, whether the need for surgery can be- Author details
1
revised, whether medication use has any influence as well Physiotherapy department, Tygerberg Hospital, Cape Town, South Africa.
2
ICAS South Africa, Musculoskeletal Health, Johannesburg, South Africa.
as whether such a pre-operative intervention can have any 3
Department of Health & Rehab Sciences, Faculty of Health Sciences,
significant effects post-operatively. University of Cape Town, Cape Town, South Africa.
Saw et al. BMC Musculoskeletal Disorders (2016) 17:236 Page 13 of 14

Received: 8 September 2015 Accepted: 19 May 2016 osteoarthritis. A randomized clinical trial protocol. BMC
Musculoskelet Disord. 2013;14:21.
20. Gill SD, McBurney H. Does Exercise Reduce Pain and Improve Physical
Function Before Hip or Knee Replacement Surgery? A Systematic Review
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