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Manual Therapy
journal homepage: www.elsevier.com/math
Original article
Pain biology education and exercise classes compared to pain biology education
alone for individuals with chronic low back pain: A pilot randomised
controlled trial
Cormac G. Ryan*, Heather G. Gray, Mary Newton, Malcolm H. Granat
School of Health, Glasgow Caledonian University, Scotland G4 0BA, UK
a r t i c l e i n f o
a b s t r a c t
Article history:
Received 14 July 2009
Received in revised form
22 February 2010
Accepted 2 March 2010
The aim of this single-blind pilot RCT was to investigate the effect of pain biology education and group
exercise classes compared to pain biology education alone for individuals with chronic low back pain
(CLBP). Participants with CLBP were randomised to a pain biology education and group exercise classes
group (EDEX) [n 20] or a pain biology education only group (ED) [n 18]. The primary outcome was
pain (0e100 numerical rating scale), and self-reported function assessed using the Roland Morris
Disability Questionnaire, measured at pre-intervention, post-intervention and three month follow up.
Secondary outcome measures were pain self-efcacy, pain related fear, physical performance testing and
free-living activity monitoring. Using a linear mixed model analysis, there was a statistically signicant
interaction effect between time and intervention for both pain (F[2,49] 3.975, p < 0.05) and pain selfefcacy (F[2,51] 4.011, p < 0.05) with more favourable results for the ED group. The effects levelled off
at the three month follow up point. In the short term, pain biology education alone was more effective
for pain and pain self-efcacy than a combination of pain biology education and group exercise classes.
This pilot study highlights the need to investigate the combined effects of different interventions.
2010 Elsevier Ltd. All rights reserved.
Keywords:
Low back pain
Education
Exercise
Randomised controlled trial
1. Introduction
Chronic low back pain (CLBP) is a complex condition for which
many different interventions exists. A number of different treatments have been shown to be effective including; education, exercise, manual therapy, multidisciplinary and cognitive behavioural
interventions (Hilde and Bo, 1998; Abenhaim et al., 2000; Tugwell,
2001; Guzman et al., 2002; Moffett and Mannion, 2005; Waddell
and Burton, 2005; Airaksinen et al., 2006). Clinical management of
patients with CLBP often comprises of two or more different
management strategies delivered simultaneously. This can occur
without evidence that the two management strategies have
a synergistic effect. The interaction effects of different management
strategies need to be further investigated so that appropriate
combinations of interventions can be delivered for each patient.
Group, aerobic based, exercise classes are a common management strategy for individuals with CLBP. A number of randomised
controlled trials have found such classes to be benecial for this
patient group (Frost et al., 1995, 1998; Moffett et al., 1999; Klaber
* Corresponding author. Tel.: 44 141 331 3327; fax: 44 141 331 8112.
E-mail address: cormac.ryan@gcal.ac.uk (C.G. Ryan).
1356-689X/$ e see front matter 2010 Elsevier Ltd. All rights reserved.
doi:10.1016/j.math.2010.03.003
Moffett et al., 2004; UK BEAM Trial Team, 2004). The exact mechanisms by which group exercise classes bring about a therapeutic
effect are not fully understood. It may be that psychosocial, rather
than physical, mechanisms bring about the effect considering that
as few as four to ve classes can bring about a therapeutic effect
despite this being an insufcient training stimulus to bring about
physiological training effects (Klaber Moffett et al., 2004).
Pain biology education is a relatively new intervention for the
management of CLBP. It is a cognitive behavioural based intervention which attempts to reduce pain and disability by explaining the
biology of the pain to the patient (Butler and Moseley, 2003). This
type of education has been shown to be superior to more
biomedical forms of education for this patient group (Moseley et al.,
2004). Pain biology education has also been found to be useful
when delivered in combination with usual care physiotherapy
(Moseley, 2002).
Considering both pain biology education and group exercise
classes attempt to decrease fear of harm and increase physical
activity (PA) in a paced manner it is logical to suggest that both
interventions delivered together would have an added benet to
one another. However, the combined effect of these interventions has not been investigated. Such work is required to guide
clinical practise.
383
384
intervention group) which accounted for any differences in baseline values within participants and accounted for missing data. This
model considered repeated measures over three time periods and
two groups entered as xed factors. Additionally, the crossover
effect of group and time period was entered as an interaction term.
Within the model duration of pain was entered as a covariate to
account for differences between groups for this participant characteristic at baseline. This was the only signicantly different
characteristic between groups.
3. Results
3.1. Participants
Seventy individuals expressed an interest in taking part in this
study. The participant pathway is shown in Fig. 1. Twenty-ve
individuals initially agreed to be contacted by the researcher but
then decided not to participate in the study for the following
reasons; insufcient time, failed to opt in, not interested, no reason
given. Seven individuals consented to take part but on initial
assessment did not meet the inclusion/exclusion criteria. The
participant characteristics for the 38 individuals who provided
a full set of baseline data are presented in Table 1. There was no
signicant difference between the EDEX group and the ED group
for any of the participant characteristics except for pain duration
which was signicantly longer in the ED group.
A further seven individuals dropped out before the post treatment free-living PA data could be collected. Reasons for dropping
out at this point included insufcient time, family commitments,
one lady became pregnant and another broke her ankle, One male
participant could not be contacted. At the 3 month assessment 27
participants completed the study and 11 did not. Non-completers
were signicantly younger than completers (47.8 9.4 yrs vs.
39.3 11.8 yrs, 95% CI 15.8 to 1.2, p < 0.05). There was no
signicant difference between completers and non-completers for
gender, height, weight, BMI, duration of pain or employment status.
Exercise class attendance ranged from 0 to 6 sessions. Of the 20
participants randomised to the EDEX group, two dropped-out
Fig. 1. The gure shows the participant pathway. F females, EDEX Education and exercise group, ED Education only group.
Gender
Age
Height
Weight
BMI
Duration of pain
EDEX
(n 20)
ED
(n 18)
14F 6M
45.2 (11.9)
1.66 (0.09)
79.2 (15.1)
28.7 (5.6)
7.6 (7.0)
11F 7M
45.5 (9.5)
1.72 (0.12)
77.5 (10.7)
26.2 (3.5)
13.7 (10.2)
p-value
Mean diff
(95% CI)
0.92
0.10
0.70
0.11
0.04
0.4
0.06
1.7
2.5
6.1
(7.5 to 6.8)
(0.13 to 0.01)
(7.0 to 10.4)
(0.6 to 5.6)
(11.8 to 0.4)
385
4. Discussion
The aim of this study was to provide pilot data investigating the
combined effect of pain biology education and group exercise
classes compared to pain biology education alone for individuals
with CLBP. The ndings suggest that for pain and pain self-efcacy,
in the short term, the education only intervention had a greater
effect than the education and exercise group.
Frost et al. (1995) performed an RCT similar in design to the
current study, where one group received an education session and
one group received education as well as group exercise classes.
Frost et al. reported signicantly greater improvement in the
combined education and exercise group. In the Frost et al. study the
education was based on the medical model of back pain and
included information on anatomy, biomechanics and posture. The
pain biology education session used in the current study was
a cognitive behavioural intervention based on the biopsychosocial
model of back pain attempting to educate patients on the biology of
pain aiming to decrease fear and distress, and encourage a return to
usual daily activity (Butler and Moseley, 2003). Previous research
has directly compared these two forms of education and found pain
biology education to be superior and has suggested that
a biomedical back education may actually have a negative effect on
patient outcome (Moseley et al., 2004). Thus, in the study by Frost
et al., (1995) the back to tness classes may have shown added
benet to the education session because of the lack of effect, or
indeed negative effect of such a biomedical education.
It is unclear as to why the education only group had better short
term outcomes in this study. However there are a number of
possible explanations. Among other things, the purpose of the
education session was to demedicalise the person's condition,
shift attitudes towards a more biopsychosocial self-management
approach, and highlight that hurt does not equal harm. Attending
the exercise classes in a clinical setting with a clinical class
instructor (physiotherapist) may have detracted from that message
and reinforced the concept of the participants being patients, with
something medically/structurally wrong, requiring medical treatment. It may have reinforced the individual's perception of themselves as a patient, the patient persona. The minimally invasive
single cognitive behavioural education session may have
Table 2
Group comparisons. Data are presented as mean (SD). * Signicant at p 0.05. F and p-values were calculated using a mixed model analysis.
Pre
Primary outcome measures
Function (0e24)
Exercise & Education
Education
Pain (0e100)
Exercise & Education
Education
Secondary outcome measures
Pain related fear (13e52)
Exercise & Education
Education
Pain self-efcacy (0e60)
Exercise & Education
Education
50 ft walk (sec)
Exercise & Education
Education
5 min walk (m)
Exercise & Education
Education
Free-living step count (steps)
Exercise & Education
Education
Post
FU
F-value
p-value
9.4 (4.2)
10.8 (5.2)
5.6 (3.9)
3.3 (3.0)
6.4 (5.1)
4.3 (4.2)
2.152
0.127
28.1 (20.4)
39.3 (26.2)
23.9 (23.3)
8.4 (7.5)
19.1 (18.9)
22.6 (30.8)
3.975
0.025*
25.8 (7.4)
28.4 (8.2)
21.9 (8.2)
21.3 (6.5)
21.5 (7.5)
23.7 (6.6)
0.440
0.646
50.0 (11.4)
41.9 (12.5)
48.8 (12.2)
55.1 (4.7)
49.5 (13.1)
49.5 (9.8)
4.011
0.024*
11.42 (3.82)
9.79 (2.56)
10.76 (2.76)
9.00 (1.68)
0.009
0.924
390.2 (89.8)
439.1 (86.6)
433.9 (81.42)
490.6 (85.1)
0.037
0.848
8284 (3725)
8001 (2071)
8927 (3932)
9166 (2774)
0.111
0.740
386
Fig. 2. The Function scores for both groups, pre-intervention, post-intervention and at
the three month follow up stage. Data are presented as mean (SD). RMDQ Roland
Morris Disability Questionnaire.
Fig. 3. The pain scores for both groups, pre-intervention, post-intervention and at
the three month follow up stage. Data are presented as mean (SD). NRS numerical
rating scale.
This study was funded by the School of Health and Social Care of
Glasgow Caledonian University, and no nancial support was
received from any commercial company. One of the authors is a coinventor of the activPAL physical activity monitor and a director of
PAL technologies Ltd. The remaining authors declare no competing
interests. The authors would like to acknowledge the signicant
statistical input of Dr. Sebastien Chastin and Dr. Jon Godwin of Glasgow Caledonian University.
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