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Individualised cognitive functional
therapy compared with a combined
exercise and pain education class for
patients with non-specific chronic low
back pain: study protocol for a
multicentre randomised controlled trial
Mary O’Keeffe,
1
Helen Purtill,
2
Norelee Kennedy,
1
Peter O’Sullivan,
3
Wim Dankaerts,
4
Aidan Tighe,
5
Lars Allworthy,
6
Louise Dolan,
7
Norma Bargary,
2
Kieran O’Sullivan
1
To cite: O’Keeffe M, Purtill H,
Kennedy N, et al.
Individualised cognitive
functional therapy compared
with a combined exercise and
pain education class for
patients with non-specific
chronic low back pain: study
protocol for a multicentre
randomised controlled trial.
BMJ Open 2015;5:e007156.
doi:10.1136/bmjopen-2014-
007156
▸Prepublication history
and additional material is
available. To view please visit
the journal (http://dx.doi.org/
10.1136/bmjopen-2014-
007156).
Received 9 November 2014
Revised 8 April 2015
Accepted 10 April 2015
For numbered affiliations see
end of article.
Correspondence to
Mary O’Keeffe;
Mary.OKeeffe@ul.ie
ABSTRACT
Introduction: Non-specific chronic low back pain
(NSCLBP) is a very common and costly
musculoskeletal disorder associated with a complex
interplay of biopsychosocial factors. Cognitive
functional therapy (CFT) represents a novel, patient-
centred intervention which directly challenges pain-
related behaviours in a cognitively integrated,
functionally specific and graduated manner. CFT aims
to target all biopsychosocial factors that are deemed to
be barriers to recovery for an individual patient with
NSCLBP. A recent randomised controlled trial (RCT)
demonstrated the superiority of individualised CFT for
NSCLBP compared to manual therapy combined with
exercise. However, several previous RCTs have
suggested that class-based interventions are as
effective as individualised interventions. Therefore, it is
important to examine whether an individualised
intervention, such as CFT, demonstrates clinical
effectiveness compared to a relatively cheaper exercise
and education class. The current study will compare
the clinical effectiveness of individualised CFT with a
combined exercise and pain education class in people
with NSCLBP.
Methods and analysis: This study is a multicentre
RCT. 214 participants, aged 18–75 years, with NSCLBP
for at least 6 months will be randomised to one of two
interventions across three sites. The experimental
group will receive individualised CFT and the length of
the intervention will be varied in a pragmatic manner
based on the clinical progression of participants. The
control group will attend six classes which will be
provided over a period of 6–8 weeks. Participants will
be assessed preintervention, postintervention and after
6 and12 months. The primary outcomes will be
functional disability and pain intensity. Non-specific
predictors, moderators and mediators of outcome will
also be analysed.
Ethics and dissemination: Ethical approval has
been obtained from the Mayo General Hospital
Research Ethics Committee (MGH-14-UL). Outcomes
will be disseminated through publication according to
the SPIRIT statement and will be presented at scientific
conferences.
Trial registration number: (ClinicalTrials.gov
NCT02145728).
INTRODUCTION
Non-specific chronic low back pain (NSCLBP)
is a very common and costly musculoskeletal
disorder, resulting in significant personal,
social and economic burden.
1–3
There is
strong evidence that NSCLBP is associated
with a complex interaction of factors. These
include physical factors (eg, maladaptive
Strengths and limitations of this study
▪This will be the first randomised controlled trial to
compare the clinical effectiveness of a novel indivi-
dualised treatment called cognitive functional
therapy with a combined exercise and pain educa-
tion class in people with non-specific chronic low
back pain (NSCLBP).
▪Methodological qualities of the trial include: three
intervention sites, blinded assessment and con-
cealed allocation, an active comparison group,
long-term follow-up, appropriate sample size cal-
culation, treatment fidelity measures and a planned
intention-to-treat analysis.
▪Only patients with NSCLBP greater than 6 months
will be included, and while inclusion and exclusion
criteria are broad, the study results will not be gen-
eralisable to all people with low back pain.
▪Therapist and patient blinding is not possible.
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postures and movement patterns, altered body perception,
pain behaviours and deconditioning),
4–8
cognitive factors
(eg, unhelpful beliefs, catastrophising, hypervigilance,
maladaptive coping strategies, poor self-efficacy),
9–14
psychological factors (eg, fear, anxiety, depression),
15–18
lifestyle factors (eg, physical inactivity, sleep problems,
chronic life stress),
19–22
neurophysiological factors (eg,
peripheral and central nervous system sensitisation),
23–27
and social factors (eg, socioeconomic status, family, work
and culture).
28 29
Despite this complex interaction of
factors in NSCLBP, with many of these factors being
potentially modifiable, most current interventions neither
target multiple aspects of an individual’s pain experience
nor individualise the targeting of such factors for
each patient.
30 31
Therefore, it is not surprising that treat-
ments such as manual therapy, exercise, medications,
relaxation, cognitive behavioural therapy and acceptance
and commitment therapy, while reducing disability and
enhancing quality of life to an extent, are not superior to
each other and have a limited impact on pain in the long
term.
32–38
Cognitive functional therapy (CFT) is a novel, patient-
centred behavioural intervention which addresses mul-
tiple aspects in NSCLBP. This approach focuses on
changing patient beliefs, confronting their fears, educat-
ing them about pain mechanisms, enhancing mindful-
ness of the control of their body during pain provocative
functional tasks, training them to reduce excessive trunk
muscle activity and change behaviours related to pain
provocative movements and postures.
31
In a recent ran-
domised controlled trial (RCT) among people with
moderate NSCLBP, this approach was significantly more
effective than combining manual therapy and exercise.
39
Similar results were demonstrated for a high-risk group
of patients with NSCLBP treated with CFT in a recent
single-centre cohort study in Ireland.
40
However, a range
of RCTs have suggested that class-based treatments are
as effective as individualised treatment in musculoskel-
etal pain populations,
41–52
including NSCLBP. In add-
ition, many people with chronic musculoskeletal pain,
including NSCLBP, appear to be either over-treated or
treated inefficiently, without this additional one to one
intervention necessarily improving their outcome.
53–57
Therefore, it is important to examine whether an indivi-
dualised intervention, such as CFT, is demonstrative of
clinical-effectiveness as compared to a relatively cheap
comparison treatment such as a combined exercise and
pain education class.
OBJECTIVES
Primary objective
The primary objective is to examine the clinical effect-
iveness of CFT, based on whether participants in the
CFT arm report significant improvements in the short,
medium and long term on measures of functional dis-
ability and pain intensity, relative to those allocated to
combined exercise and pain education classes.
Secondary objectives
The secondary objectives include examining whether
CFT has a significant effect on costs relative to classes in
the short, medium and long term, and examining med-
iators (back pain beliefs, fear, coping, self-efficacy, sleep,
depression, anxiety, stress and treatment satisfaction) as
well as moderators and predictors (demographic infor-
mation (age, sex, duration of CLBP), socioeconomic
status, baseline risk of chronicity, number of pain areas
and general health symptoms) of treatment effect across
both interventions.
METHODS AND ANALYSIS
Design and setting
The design is a three site RCT comparing individualised
CFT and a class-based intervention. The sites are two
primary care centres (Ballina Primary Care Centre and
Claremorris Primary Care Centre) and one public hos-
pital (Mayo General Hospital) that receives referrals
from both medical consultants in secondary care and
primary care general practitioners (GPs) in Ireland. Any
modifications to the protocol which may impact on the
conduct of the study will require a formal amendment
to the protocol. Such amendment will be agreed on by
the project management committee (MOK, KOS, NK,
POS, HP and NB) and approved by the relevant ethics
committee prior to the implementation of the modifica-
tions. Minor administrative changes to the protocol will
be agreed on by the project management committee
and will be documented in a memorandum.
Ethical considerations
Ethical approval has been granted by the relevant hos-
pital research ethics committee (MGH-14-UL). Written
informed consent will be obtained from all participants
included in the study. Participants will be informed that
they are not obliged to take part in the study and are free
to withdraw at any time, without any negative conse-
quences on their future care. All efforts will be made to
protect the privacy of the participants, and to keep their
names and personal information confidential at all times.
This will be achieved by referring to all participant
records and information only by their assigned research
code. No significant adverse reactions are anticipated in
the study, but these will be monitored. Both interventions
will involve some exercise. This involves a very small risk
of increased stiffness and soreness initially. However, all
exercise will be performed at a speed and intensity under
the participant’s own control. The suitability of exercise
for the participants will be assessed at entry to the study
by the treating physiotherapist.
Recruitment and participants
Participants who are referred to the physiotherapy
service in each site will be screened individually for
15–20 min. Participants meeting the eligibility criteria
will be recruited. All participants will be given the
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option of receiving usual care physiotherapy (individua-
lised) or taking part in the study. Those interested in
participating will be presented with written information
about the study, including its aims and procedures (see
online supplementary file 1). Here it is clearly stated
that there are two active intervention arms and that
based on current knowledge, it is not known which
intervention is superior. The patients will provide written
informed consent prior to randomisation (see online
supplementary file 2). The inclusion/exclusion criteria
are described in table 1.
Treatment allocation and randomisation
To ensure concealment of allocation, patients will only
be randomised to receive the individualised CFT or the
class-based intervention after it is clear that they meet
the inclusion criteria. Allocation will be picked from an
opaque envelope. The envelope will contain only two
pieces of paper. Participants will be asked to pick one
piece of paper from the envelope. One piece of paper
will have the letter ‘C’for class and the other, letter ‘I’
for individual CFT. The number of participants who
choose to withdraw from the study at this, or any other,
stage will be recorded. Participant progress through the
study is shown in figure 1.
Baseline assessments
At the initial screening assessment when patients are
screened for eligibility, all will have to complete the
ODI
58
to ensure they meet the criteria for inclusion. If
eligible, and participants consent to participate after
random allocation, they then complete the remaining
sections of the questionnaire (see below) before their
first intervention session which is within 2 weeks of the
date of screening. In the event that their appointment is
longer than 2 weeks after the initial screening session,
they will recomplete all the questionnaires on the day of
the first intervention session. The second of these base-
line assessments will be used as baseline. In the event of
an individual’s ODI being less than 14%, they will remain
in the study since they have already been randomised.
INTERVENTIONS
All interventions will be provided by three physiothera-
pists (AT, LD and LA), with one physiotherapist working
in each location. The treating physiotherapists have
been trained to deliver the interventions to enhance
standardisation of interventions. Training involved a
blended learning approach, including interactive lec-
tures and seminars, as well as clinical workshops where
the management of NSCLBP as a multidimensional
biopsychosocial disorder was discussed. Both interven-
tions use a biopsychosocial approach.
The specific training for the CFT intervention
involved the treating physiotherapists (1) observing
CFT-trained tutors (http://www.pain-ed.com) assess and
treat real patients with NSCLBP using CFT, and (2)
assessing and treating patients with NSCLBP in front of
the same CFT tutors. The specific training for the class-
based intervention involved the development of a series
of six classes, each including exercise and education.
Discussions between the three treating physiotherapists
and two of the study authors (KOS and MOK) will take
place to ensure effective and consistent delivery across
sites.
Table 1 Inclusion and exclusion criteria for study participation
Inclusion criteria Exclusion criteria
▸Aged between 18 and 75
▸Chronic low back pain for at least 6 months duration
▸Score of 14% or more for disability on the Oswestry
Disability Index (ODI)
▸Independently mobile (with or without aids), to be
capable of participating in a rehabilitation programme
▸Be able to speak and understand English well enough
to be able to complete the questionnaires
independently
▸Primary pain area is not the lumbar spine (from T12 to
buttocks)
▸Leg pain as the primary problem (eg, nerve root compression
or disc prolapse with true radicular pain/radiculopathy, lateral
recess or central spinal stenosis)
▸Less than 6 months after lumbar spine, lower limb or abdominal
surgery
▸Pain relieving procedures such as injection-based therapy
(eg, epidurals) and day case procedures (eg, rhizotomy) in the
past 3 months
▸Pregnancy
▸Rheumatological/inflammatory disease (eg, rheumatoid
arthritis, ankylosing spondylitis, psoriatic arthritis, lupus
erythematosus, Scheuermann’s disease)
▸Progressive neurological disease (eg, multiple sclerosis,
Parkinson’s disease, motor neuron disease)
▸Scoliosis (if considered the primary driver of pain)
▸Unstable cardiac conditions
▸Red flag disorders like malignancy/cancer, acute traumas like
fracture (less than 6 months ago) or infection, spinal cord
compression/cauda equina
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For both intervention arms, treating physiotherapists
piloted the interventions until they were deemed
competent to deliver the interventions. Treating phy-
siotherapists were also provided with additional resources
to support both the interventions, including written and
web-based resources (eg, http://www.pain-ed.com)
regarding the biopsychosocial nature of pain, the limited
role of imaging in NSCLBP, and the role of behavioural
changes such as activity, stress management and sleep
hygiene in managing NSCLBP.
Experimental intervention: individualised CFT
The CFT intervention will be one to one, will involve
hearing the full patient story regarding their pain, and
the intervention will be targeted to meet the participants’
individual needs. All participants randomised to this
group will undergo a comprehensive one-to-one
interview and physical examination by the treating
physiotherapist. This detailed examination will be essen-
tial in order to broadly identify the modifiable multidi-
mensional drivers of pain and disability (pain provocative
cognitive, movement and lifestyle behaviours) for each
participant.
39 40 59
During the interview, participants will be asked to
provide information about their history of pain, pain area
and nature, pain behaviour (aggravating/easing move-
ments and activities), their primary functional impair-
ments, disability, activity levels, lifestyle behaviours and
sleep patterns. Participants will be also be questioned
about their level of fear of pain and any avoidance of
activities, work and social engagement. Their degree of
pain focus, pain coping strategies, stress response and its
relationship to pain, and their pain beliefs will also be
established as will be any history of anxiety and
Figure 1 Trial design.
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depression. Finally, their beliefs and goals regarding man-
agement of their disorder will be ascertained.
39 40 59
The physical examination will involve analysis of the
participants’primary functional impairments (eg, pain
provocative, feared and/or avoided movements and
functional tasks as reported during the interview), in
order to identify maladaptive behaviours which include
muscle guarding, ‘abnormal’movements and postures,
avoidant patterns and pain behaviours. They will also be
assessed regarding their level of body control and aware-
ness (body perception), as well as their ability to relax
their trunk muscles and normalise pain provocative pos-
tural and movement behaviours, and the effect this has
on their pain.
39 40 59
Treatment will be provided in the local physiotherapy
department at each site. The initial session will last
approximately 1 h and follow-up sessions will range from
30 min to 1 h. Treatment frequency will vary pragmatic-
ally with each patient, though it is expected that
appointments will start weekly and reduce in frequency
over time. Similarly, treatment duration will vary from
approximately 4 to 16 sessions. While 16 is the antici-
pated upper limit of sessions, eight is the expected
average. The duration, and number, of treatments will
be recorded. Each patient will receive an individualised
targeted intervention directed at changing their individ-
ual cognitive, movement and lifestyle behaviours consid-
ered to be provocative and maladaptive of their
disorder.
63160
There will be four main components to
the intervention. These will be:
1. A cognitive component will focus on the factors identi-
fied from the examination that are considered to con-
tribute to their pain disorder. This will include
discussing the multidimensional nature of persistent
pain as it pertains to the individual—and how beliefs,
emotions and behaviours (movement and lifestyle) can
reinforce a vicious cycle of pain sensitisation and dis-
ability. The various factors of the vicious cycle will be
outlined in a personalised diagram for each participant
based on the findings from the examination. Where
considered appropriate, patients will be advised to read
resources and watch patient videos on http://www.
pain-ed.com and will be given leaflets on sleep, relax-
ation and mindfulness, the role of spinal imaging, such
as MRIs, and regarding exercise and physical activity if
these are considered relevant to their pain presentation
by the treating physiotherapist.
2. Specific functional training will be designed to nor-
malise maladaptive and provocative postural and
movement behaviours as directed by the patient’s
individual presentation. This will involve a behav-
ioural modification approach to rehabilitation where
patients will be taught strategies aimed to enhance
their body awareness and control in order to relax,
and modify postures and tasks they report as being
pain provocative. Where considered appropriate,
patients will be given audio resources (eg, mindful-
ness CDs) to facilitate this process.
3. Targeted functional integration into daily life activ-
ities which are avoided by, and/or provocative for,
the patient. This will vary between individuals, but
will be likely to include targeting activities such as
rolling in bed, sitting, standing up from sitting,
walking, bending and lifting.
4. Physical activity and lifestyle advice will include pro-
motion of gradually increasing physical activity based
on their preference and presentation, advice on
sleep hygiene, stress management strategies and
social re-engagement.
39 40 59
A key component underlying each of these four stages
which may facilitate patients achieving a positive outcome
will be maximising the contextual or ‘non-specific’
aspects of treatment. This will include using motivational
interviewing techniques,
61
as well as establishing and
demonstrating empathy with the patient to enhance
patient–therapist rapport and interaction.
62
All instruc-
tions for participants will be written, when deemed
appropriate by the physiotherapist and/or requested by
the participants.
Control intervention: combined exercise and pain
education class
This class-based intervention will not involve individual
assessment or consideration of the patient’s story. All
participants in this class will receive the same interven-
tion and it will not be specifically targeted to their indi-
vidual needs.
The class-based intervention will consist of six classes
over 6–8 weeks, each lasting approximately 1 h and
15 min, with up to 10 participants in each class. It will
have biopsychosocially orientated sessions involving edu-
cation, exercise and relaxation/mindfulness. Everybody
will have the opportunity to ask questions and answers
will be provided for the whole class. It differs from the
individualised CFT in that it is not targeted to the indi-
vidual, it does not involve one-to-one attention, and
everybody gets the same advice and functional activation
exercises. Each class will start with a 30 min discussion,
using a different focus/topic each week. The topics to
be covered will include explaining contemporary under-
standing of pain and the role of the nervous system,
63
the multidimensional nature of CLBP and common
myths about CLBP, posture and ergonomics, exercise,
relaxation and sleep. All talks will involve the use of
visual aids (eg, slides, flipcharts) and a copy of the slides
from every class will be provided to participants. The
second part of the class will be a 40 min gradually pro-
gressive exercise circuit involving aerobic, flexibility and
strengthening exercises, similar to the class-based inter-
vention delivered in a previous RCT.
64
The exercises will
be step-ups, squats, sit to stands, marching/jogging on
spot, wall push-ups, hip lift/bridging, knees to chest/
lumbar flexion, rolling knee to side/lumbar rotation,
the cat stretch and the hip flexor lunge stretch.
Participants will be instructed to do the exercises at their
own desired pace. No special equipment will be needed.
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All participants will be given a copy of these exercises to
do at home and will be encouraged to do these once a
day. Finally, a 5 min relaxation/mindfulness component
will take place at the end of each class. In addition, all
participants will be advised to watch patient videos and
read resources on http://www.pain-ed.com, and will
receive the aforementioned leaflets on sleep, relaxation
and mindfulness, the role of spinal imaging, such as
MRI, and on exercise and physical activity. Efforts will be
made to enhance the ‘non-specific’aspects of treatment
by creating an open atmosphere, encouraging patient
interaction, engagement and opportunity for questions
and input.
OUTCOME MEASURES
All outcome measures will be self-reported and will be
conducted preintervention (see online supplementary
file 3), postintervention (see online supplementary
file 4) as well as 6 and 12 months (see online supplemen-
tary file 5) after randomisation. The primary outcome
measures selected for this study are based on the
Initiative on Methods, Measurement and Pain
Assessment in Clinical Trials (IMMPACT) recommenda-
tions for outcome measures for chronic pain clinical
trials. The rate of attrition among the participants during
their completion of the intervention will be recorded.
Primary outcomes
The two primary outcomes of interest will be functional
disability and pain intensity. Functional disability will be
measured using the ODI, a validated 10-item question-
naire.
58
Pain intensity will be assessed using the Numeric
Rating Scale, a validated 0–10 scale.
65
Participants will
asked to rate their pain on average during the past
week; 0 representing no pain and 10 representing pain
as bad as you can imagine. Both will be assessed at all
time-points (baseline, postintervention, as well as 6 and
12 months after randomisation).
Secondary outcomes
The secondary outcome of interest will be costs.
Treatments and tests received, hospitalisations and tests,
medications, equipment, aids and informal care, travel
costs, employment status and work absenteeism will be
assessed. The number and length of treatment sessions
will also be documented by the treating physiotherapists.
This will be assessed at 6 and 12 months (see online sup-
plementary file 6).
Mediators of outcome
▸Beliefs: Beliefs about back pain will be assessed using
the nine-item Back Beliefs Questionnaire.
66
▸Fear: this will be measured using the four-item phys-
ical activity subscale of the Fear-Avoidance Beliefs
Questionnaire.
67
▸Coping: this will be measured using the five-item coping
subscale of the Coping Strategies Questionnaire.
68
▸Self-efficacy: this will be assessed using the 10-item Pain
Self-Efficacy Questionnaire.
69
▸Sleep, depression and anxiety: these will be assessed using
the single item questions regarding these measures on
the Subjective Health Complaints Inventory.
70
▸Stress: this will be measured using the seven-item
stress subscale of the Depression, Anxiety and Stress
Scale.
71
▸Satisfaction: participant satisfaction with treatment will
be assessed using a single item from the 18-item
Patient Satisfaction Questionnaire. “The care that I
have been receiving here is just about perfect”.
1=Strongly Agree, 2=Agree, 3=Unsure, 4=Disagree,
5=Strongly Disagree.
72
Satisfaction will be assessed at postintervention only
while the remaining mediators will be assessed at all
time-points (baseline, postintervention, 6 and 12 months
follow-up).
Non-specific predictors and moderators of outcome
▸Demographic information: Participants’age, sex, dur-
ation of NSCLBP will be obtained.
▸Socioeconomic status: this will be assessed using the
Socioeconomic Index.
73
This questionnaire provides
information about education, employment status,
income, ability to pay bills, self-perceived health and
satisfaction with number of friends. While aspects of
some of these (eg, education) are unlikely to change,
some (eg, work status, self-perceived health) may
actually be targets of treatment.
▸Risk of chronicity: this will be measured using the
10-item short-form Orebro musculoskeletal screening
questionnaire.
74
▸Number of pain areas: this will be assessed using the
Nordic Musculoskeletal Screening Questionnaire.
75
▸General Health: general health symptoms will be
assessed using the 13-item version of the Subjective
Health Complaints Inventory
70
and scored as simply
the presence or absence of the 13 items.
Demographic information will be obtained at baseline
only, while the remaining predictors and moderators will
be assessed at all the time points.
Timing of outcome measurement
The aforementioned patient self-report outcomes will be
collected at baseline (except satisfaction and costs) and
immediately after the intervention by the treating
physiotherapist. Costs will only be assessed 6 and
12 months after randomisation. Participants will then be
sent copies of the same questionnaires by a blinded
assessor (MOK) 6 and 12 months after their randomisa-
tion. If a participant does not respond to follow-up, they
will be telephoned on up to two occasions each time to
ask if they wish to complete the questionnaires.
Blinding
Questionnaires at all time points will be self-completed
by the patient. Single blinding will be achieved by
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having an independent blinded assessor perform the
follow-up assessments after 6 and 12 months.
Questionnaires will be posted back to the blinded asses-
sor. The blinded assessor will not be treating any of the
participants, nor be aware of their group allocation. The
statistician conducting the primary data analysis will also
be blinded to group allocation. Blinding of the treating
physiotherapists and participants will not be possible
because they will know the intervention arm to which
they have been allocated.
Data and treatment fidelity
Afidelity evaluation where the treating physiotherapists
are observed while assessing and treating actual patients
from the RCT will be conducted. For every participant in
the study, the type and number of treatments received will
be recorded. In addition, there will be session-by-session
documentation of treatment content for the CFT arm by
the treating physiotherapist. Standardised and regular
training as well as monitoring and feedback will be given
to the physiotherapists to facilitate successful delivery of
both treatments. Physiotherapists will complete a series of
standardised questionnaires (see online supplementary
file 7) assessing their beliefs and attitudes towards CLBP
and pain presentations (Health Care Professionals
Pain and Impairment Relationship Scale,
76
The Pain
Attitudes and Beliefs Scale For Physiotherapists,
77
The
Practitioner Confidence Scale,
78
The Attitudes to Back
Pain Scale in Musculoskeletal Practitioners,
79
and The
Neurophysiology of Pain Questionnaire).
80
The phy-
siotherapists will also be asked to complete a clinical
vignette
81
and to provide demographic details, informa-
tion about their physiotherapy training and general
health. To assess quality of communication and inter-
action, some sessions from both intervention arms will be
observed and audio recorded. These recorded sessions
will also involve the physiotherapist, patient(s) and an
observer completing the Working Alliance Theory of
Change Inventory;
82
physiotherapists will complete the
Communication Assessment Tool.
83
Qualitative interviews
will be carried out with 8–15 participants from each treat-
ment arm, depending on data saturation. Stratified sam-
pling for these patient interviews will take place and be
based on reaching the minimal clinically important differ-
ence (MCID) of ODI (30%)
84
at 6-month follow-up.
Participants will then be randomly selected and interviews
will be conducted 6 to 12 months following randomisation
to get their views on the care they received.
Statistical analysis
Descriptive statistics will be used to summarise partici-
pant characteristics in the individualised CFT and class-
based intervention. An intention to treat analysis using
linear mixed models will be used to compare pain inten-
sity and functional disability between the intervention
arms and account for the correlation within-subject over
time, while adjusting for differences in participant
characteristics at baseline where appropriate. Sensitivity
analyses and per protocol analysis will be used to
explore whether adherence to the intervention influ-
ences the effect of the intervention on the primary out-
comes. The analysis of the secondary outcomes will
involve linear and non-linear mixed models for continu-
ous and categorical responses where appropriate.
Variable selection techniques will be used to identify the
most parsimonious set of participant characteristics for
inclusion as explanatory variables in each model. An
analysis of the potential mediating effects of the second-
ary outcomes on treatment will be undertaken using the
approach of Baron and Kenny.
85
In addition, baseline
variables will be assessed as non-specific predictors or
moderators of treatment by including main and inter-
action terms in the models. The 5% level of statistical
significance will be used throughout the analyses. In
addition, the level of clinical significance will be also be
reported by comparing any changes in outcome mea-
sures to the recognised MCID values
84
for standardised
outcome measures. A responder to treatment is defined
as a >30% improvement on the ODI.
84
All data will be
analysed using the IBM SPSS Statistics V. 21 (Armonk,
New York, USA) and R 3.1.1.
86
Data will be inputted by
one researcher (MOK) and a second researcher will ran-
domly double-check 10% of the inputted data to ensure
accuracy.
A thematic analysis approach will be used to analyse
the qualitative interviews. When all the audio recordings
have been transcribed verbatim, the transcripts will be
imported into NVIVO 10. The analytic process will be
adapted from Sandelowski and Barroso.
87
It will involve
the following three stages: (1) Extraction of findings and
coding of findings for each interview, (2) Grouping of
findings (codes) according to their topical similarity and
(3) Abstraction of findings—analysing the grouped find-
ings to identify additional patterns, overlaps, compari-
sons and redundancies to form a set of concise
statements, which capture the content of all findings.
Analysis of costs to the participant after intervention
The cost analysis of participants after intervention
will be undertaken at the follow-up times, 6 and
12 months after initial randomisation. The aims of the
analysis will be to identify, measure and compare individ-
ual costs incurred by the participants in both groups.
Concomitant care, interventions and tests received, hos-
pitalisations and tests, medications, equipment, aids and
informal care, travel costs, employment status and work
absenteeism will be assessed by a postal questionnaire at
these follow-up times and statistical analyses will
compare differences between the treatment groups.
Sample size estimation
Based on the previous RCT using CFT,
39
asamplesizecal-
culation estimates that a sample size of 64 in each group
will have 80% power to detect a difference in means of 5.0
(disability) and 1.0 (pain) between the two arms of the
study, assuming that the common SD is 10.0 (disability)
O’Keeffe M, et al.BMJ Open 2015;5:e007156. doi:10.1136/bmjopen-2014-007156 7
Open Access
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and 2.0 (pain), and using a two-sided 5% significance test.
Pilot data collection suggests a slightly larger drop-out rate
from the class-based intervention. Consequently, allowing
for a 40% dropout rate requires a sample size in each arm
of 107, or an overall sample size of 214.
DATA AND SAFETY MONITORING
The Clinical Therapies Department at the University of
Limerick, Ireland, will serve as the data coordinating
centre responsible for data collection forms, coordin-
ation of data transfer and data analysis. Health of partici-
pants will be monitored through attending their
interventions in the three sites. If any adverse events do
take place, and in the unlikely event that harm is suf-
fered, the project management team will liaise with local
health service providers. All adverse events will be docu-
mented in the final written report of this study. All study
data will be stored securely in the University of Limerick.
All paper-based documents and data will be stored in a
secure filing cabinet. All electronic data will be secured
on a password-protected laptop. All documents that
contain names or personal identifying information will
be stored separately from other study data and identified
by code number. Access to files will be limited to
research staff involved in the study. The statistician for
the final analysis will receive depersonalised data where
the participants’identifying information will be replaced
by an unrelated sequence of numbers. There are no
current plans for granting public access to the full proto-
col, participant-level data set or statistical code. However,
if researchers wish to access the data set (eg, for
conduct of secondary analysis or meta-analysis) the
project management committee will try to facilitate this.
DISSEMINATION
Results will be presented at international scientific con-
ferences and in peer-reviewed publications. An open-
access version of the study results will be made available
through the University of Limerick’s institutional reposi-
tory. Trial participants will also be offered an opportun-
ity to obtain the anonymised, overall study results.
CONCLUSION
This will be the first RCT to compare the clinical effect-
iveness of individualised CFT and a combined exercise
and education class for people with NSCLBP. The study
results will provide valuable information about the role
of these interventions and has the potential to inform
the clinical management of NSCLBP. A 36-month
follow-up will be conducted if the 12-month follow-up
results suggest this would be useful and if funding is
available.
Author affiliations
1
Department of Clinical Therapies, University of Limerick, Limerick, Munster,
Ireland
2
Department of Mathematics and Statistics, University of Limerick, Limerick,
Munster, Ireland
3
School of Physiotherapy and Exercise Science, Curtin University, Perth,
Western Australia
4
Musculoskeletal Research Unit, Department of Rehabilitation Sciences and
Physiotherapy, University of Leuven, Leuven, Belgium
5
Ballina Primary Care Centre, Ballina, Mayo, Ireland
6
Physiotherapy Department, Mayo General Hospital, Castlebar, Mayo, Ireland
7
Claremorris Primary Care Centre, Claremorris, Mayo, Ireland
Contributors MO and KO have been primarily responsible for study
conception, design, analysis plan, funding acquisition and implementation.
NK, WD and PO contributed to the conceptualisation and design of the study
and implementation. MO drafted the background, methods and Discussion
sections of the manuscript and coordinated manuscript preparation and
revision. KO, PO and WD trained the treating physiotherapists. MO and KO
developed the paper-based resources to be used for both interventions. PO,
KO and WD have developed the http://www.pain-ed.com online platform
which will be available to support both physiotherapists and patients during
the study. AT, LA and LD contributed to the design of the interventions, data
collection process and will perform the treatment interventions in the study.
HP and NB performed the power size calculation, produced the statistical
analysis plan and will perform the final study analysis. All authors provided
critical evaluation and revision of the manuscript and have given final approval
of the manuscript accepting responsibility for all aspects.
Funding This work is sponsored by the Irish Research Council (IRC).
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical approval has been granted by the Mayo General
Hospital Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Open Access This is an Open Access article distributed in accordance with
the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
which permits others to distribute, remix, adapt, build upon this work non-
commercially, and license their derivative works on different terms, provided
the original work is properly cited and the use is non-commercial. See: http://
creativecommons.org/licenses/by-nc/4.0/
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multicentre randomised controlled trial
chronic low back pain: study protocol for a
non-specificeducation class for patients with paincompared with a combined exercise and
Individualised cognitive functional therapy
and Kieran O'Sullivan
Dankaerts, Aidan Tighe, Lars Allworthy, Louise Dolan, Norma Bargary
Mary O'Keeffe, Helen Purtill, Norelee Kennedy, Peter O'Sullivan, Wim
doi: 10.1136/bmjopen-2014-007156
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