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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

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Abstract

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. 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. 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. (ClinicalTrials.gov NCT02145728). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Individualised cognitive functional
therapy compared with a combined
exercise and pain education class for
patients with non-specic chronic low
back pain: study protocol for a
multicentre randomised controlled trial
Mary OKeeffe,
1
Helen Purtill,
2
Norelee Kennedy,
1
Peter OSullivan,
3
Wim Dankaerts,
4
Aidan Tighe,
5
Lars Allworthy,
6
Louise Dolan,
7
Norma Bargary,
2
Kieran OSullivan
1
To cite: OKeeffe 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 OKeeffe;
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 1875 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 68 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-specic chronic low back pain (NSCLBP)
is a very common and costly musculoskeletal
disorder, resulting in signicant personal,
social and economic burden.
13
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),
48
cognitive factors
(eg, unhelpful beliefs, catastrophising, hypervigilance,
maladaptive coping strategies, poor self-efcacy),
914
psychological factors (eg, fear, anxiety, depression),
1518
lifestyle factors (eg, physical inactivity, sleep problems,
chronic life stress),
1922
neurophysiological factors (eg,
peripheral and central nervous system sensitisation),
2327
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 modiable, most current interventions neither
target multiple aspects of an individuals 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.
3238
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 signicantly 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,
4152
including NSCLBP. In add-
ition, many people with chronic musculoskeletal pain,
including NSCLBP, appear to be either over-treated or
treated inefciently, without this additional one to one
intervention necessarily improving their outcome.
5357
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 signicant 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 signicant effect on costs relative to classes in
the short, medium and long term, and examining med-
iators (back pain beliefs, fear, coping, self-efcacy, 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
modications 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 modica-
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 condential at all times.
This will be achieved by referring to all participant
records and information only by their assigned research
code. No signicant 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 participants 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
1520 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 le 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 le 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 Cfor 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 gure 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
rst 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 rst intervention session. The second of these base-
line assessments will be used as baseline. In the event of
an individuals 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 specic 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 specic 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, Scheuermanns disease)
Progressive neurological disease (eg, multiple sclerosis,
Parkinsons 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 modiable 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
participantsprimary 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, abnormalmovements 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-
ed 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 individualand 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 ndings 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 leaets 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. Specic functional training will be designed to nor-
malise maladaptive and provocative postural and
movement behaviours as directed by the patients
individual presentation. This will involve a behav-
ioural modication 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-specic
aspects of treatment. This will include using motivational
interviewing techniques,
61
as well as establishing and
demonstrating empathy with the patient to enhance
patienttherapist 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 patients story. All
participants in this class will receive the same interven-
tion and it will not be specically targeted to their indi-
vidual needs.
The class-based intervention will consist of six classes
over 68 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, ipcharts) 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, exibility 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 exion, rolling knee to side/lumbar rotation,
the cat stretch and the hip exor 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 leaets 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-specicaspects 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
le 3), postintervention (see online supplementary
le 4) as well as 6 and 12 months (see online supplemen-
tary le 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 010 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 le 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 ve-item coping
subscale of the Coping Strategies Questionnaire.
68
Self-efcacy: this will be assessed using the 10-item Pain
Self-Efcacy 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: Participantsage, 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
Adelity 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
le 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 Condence 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 815 participants from each treat-
ment arm, depending on data saturation. Stratied 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 inu-
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-specic predictors or
moderators of treatment by including main and inter-
action terms in the models. The 5% level of statistical
signicance will be used throughout the analyses. In
addition, the level of clinical signicance 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 dened
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 ndings and
coding of ndings for each interview, (2) Grouping of
ndings (codes) according to their topical similarity and
(3) Abstraction of ndingsanalysing the grouped nd-
ings to identify additional patterns, overlaps, compari-
sons and redundancies to form a set of concise
statements, which capture the content of all ndings.
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)
OKeeffe 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% signicance 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 nal 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 ling 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 identied
by code number. Access to les will be limited to
research staff involved in the study. The statistician for
the nal analysis will receive depersonalised data where
the participantsidentifying 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 scientic con-
ferences and in peer-reviewed publications. An open-
access version of the study results will be made available
through the University of Limericks institutional reposi-
tory. Trial participants will also be offered an opportun-
ity to obtain the anonymised, overall study results.
CONCLUSION
This will be the rst 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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10 OKeeffe M, et al.BMJ Open 2015;5:e007156. doi:10.1136/bmjopen-2014-007156
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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
2015 5: BMJ Open
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... Although the majority of articles also used psychological outcomes in combination with biological, the psychological outcomes received less attention. For example, disability, pain intensity and pain location were the most frequent primary outcomes used to assess and evaluate patients [39][40][41][42][43][44], and active range of motion, posture and spinal movement were also frequently used [43,[45][46][47][48][49][50]. In their perspective paper about a movement control schema, Alrwaily et al. [45] suggest that this type of approach exists within a BPS perspective. ...
... This approach was believed to result in changes in patient behaviour (such as movement patterns or levels of activity), and consequently a reduction in their pain. For example, nine studies [46][47][48][49][50][57][58][59][60] referred to an intervention known as cognitive functional therapy, which was discussed in the texts as being BPS-oriented. For example, in their overview of this treatment, Cowell et al. [57, p.80] state that "Cognitive functional therapy is a biopsychosocially oriented behavioural intervention for low back pain". ...
... Patients' pain beliefs were depicted as important aspects in the assessment and/or management of LBP care within a BPS framework in these texts. For example, the Fear Avoidance Beliefs Questionnaire and Back Beliefs Questionnaire (which both assess cognitive aspects of LBP) were used often, indicating that the authors considered this an important domain of the BPS model in LBP [41,43,47,48,56,64,70]. The Pain Catastrophizing Scale (which screens for "excessively negative" pain beliefs) and Tampa Scale for Kinesiophobia (excessive fear of movement) were also used as outcome measures, but less frequently [40,62,70,71]. ...
Article
Purpose: Low back pain (LBP) is the leading cause of disability worldwide. Clinical research advocates using the biopsychosocial model (BPS) to manage LBP, however there is still no clear consensus regarding the meaning of this model in physiotherapy and how best to apply it. The aim of this study was to investigate how physiotherapy LBP literature enacts the BPS model. Material and methods: We conducted a critical review using discourse analysis of 66 articles retrieved from the PubMed and Web of Science databases. Results: Analysis suggest that many texts conflated the BPS with the biomedical model [Discourse 1: Conflating the BPS with the biomedical model]. Psychological aspects were almost exclusively conceptualised as cognitive and behavioural [Discourse 2: Cognition, behaviour, yellow flags and rapport]. Social context was rarely mentioned [Discourse 3: Brief and occasional social underpinnings]; and other broader aspects of care such as culture and power dynamics received little attention within the texts [Discourse 4: Expanded aspects of care]. Conclusion: Results imply that multiple important factors such as interpersonal or institutional power relations, cultural considerations, ethical, and social aspects of health may not be incorporated into physiotherapy research and practice when working with people with LBP.
... Participants were eligible if between 29 and 69 years of age, had low back pain for at least 3 months and had an Oswestry disability index (ODI) score of at least 14% [12]. We chose 14% to be comparable with other low back pain (LBP) studies as for recruitment purposes [13][14][15]. A good understanding of German or English (written and spoken) was mandatory. ...
... In the design of future trials, we also suggest carefully assessing the cut-off value of the ODI. In our study we chose 14% for recruitment purposes and to be comparable with other LBP studies [13][14][15], but it could be too low to measure clinical important differences. ...
Article
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Background: Currently, very little is known about the effects of an endurance high intensity interval training (HIIT) in chronic low back pain patients. Therefore, the feasibility and safety of the HIIT must be assessed first before Currently, very little is known about the effects of an endurance high intensity interval training in chronic low back pain patients. Therefore, the feasibility and safety of the HIIT has to be assessed first before it can be integrated safely into research and daily practice it can be integrated safely into research and daily practice. This study aims to answers the question if high intensity interval training and moderate intensity continuous training (MICT) have comparable adherence and feasibility. Methods: Participants (age from 29 to 69 years) with non-specific chronic low back pain were recruited in this randomised, single-blinded, allocation concealed, feasibility study. The participants trained 30 min on a cycle ergometer for 12 weeks. One group had HIIT and the other MICT. Results: Of 45 screened subjects 30 participated. The adherence rate was 94% in the HIIT group (median 0.94, IQR 0.23) versus 96% in the MICT group (median 0.96, IQR 0.08), without between-group differences: estimated median of the difference of - 0,01 [95% CI, - 0.11 to 0.06; p = 0.76]. Similar results in enjoyability (median 3, IQR 1 vs median 2, IQR 1.8) and willingness to continue the training (median 3, IQR 1 vs median 3, IQR 0.4). Both groups improved in pain and disability, without between-group differences in pain [median of the difference, 0.5; 95% CI, - 1 to 2; p = 0.95] nor in disability [median of the difference, 1.78; 95% CI, - 6.44 to 9.56; p = 0.64]. Conclusion: There were no differences in adherence rates. HIIT is as feasible as MICT in non-specific chronic low back pain and can be used in future larger trials to deepen the knowledge about HIIT in this specific population. Trial registration: ClinicalTrials.gov, NCT04055545 . Registered 13 August 2019.
... 4 pain [22,25]. The clinical journey is adapted to the individual's profile following three main components: (i) making sense of pain, (ii) exposure with control and (iii) lifestyle changes [25]. ...
Article
Cognitive functional therapy (CFT) is a physiotherapy-led intervention which has evolved from an integration of foundational behavioral psychology and neuroscience within the physiotherapist practice directed at the multidimensional nature of chronic low back pain (CLBP). The current evidence about the comparative effectiveness of CFT for CLBP is still scarce. We aimed to investigate whether CFT is more effective than core training exercise and manual therapy (CORE-MT) in pain and disability in patients with CLBP. A total of 148 adults with CLBP were randomly assigned to receive five one-hour individualised sessions of either CFT (n = 74) or CORE-MT (n = 74) within a period of 8 weeks. Primary outcomes were pain intensity (numeric pain rating scale, 0-10) and disability (Oswestry Disability Index, 0-100) at 8 weeks. Patients were assessed pre-intervention, at 8 weeks, 6 and 12 months after the first treatment session. Altogether, 97.3% (n=72) of patients in each intervention group completed the 8 weeks of the trial. CFT was more effective than CORE-MT in disability at 8 weeks (MD= -4.75; 95% CI -8.38 to -1.11; p=0.011, effect size= 0.55), but not in pain intensity (MD= -0.04; 95% CI -0.79 to 0.71; p=0.916). Treatment with CFT reduced disability, but the difference was not clinically important compared with CORE-MT post-intervention (short term) in patients with CLBP. There was no difference in pain intensity between interventions, and the treatment effect was not maintained in the mid-term and long-term follow-ups.
... NSCLBP is no longer considered a purely structural, anatomical, or biomechanical disorder of the lumbar spine. Instead, there is strong evidence that NSCLBP is associated with a complex interaction of factors involve structural or biomechanical, cognitive (e.g., unhelpful beliefs, catastrophizing, maladaptive coping strategies, low self-efficacy), psychological (e.g., fear, anxiety, depression), lifestyle (e.g., immobility, sleep problems), and social (e.g., work and family issues) factors [1,8,[10][11][12][13]. Consequently, NSCLBP treatment guidelines generally acknowledge a shift from biomedical models to the biopsychosocial model. ...
Article
Full-text available
Background Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance the clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on a biopsychosocial approach compared to usual care physiotherapy, on clinical findings and electroencephalography spectrum in non-specific chronic low back pain. Methods This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4 months follow-up. Seventy NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy); each group will receive 6 weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion, and psychosocial correlates. Assessment will be performed at baseline, post-treatment, and at 1 and 4 months follow-up. Discussion Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain. Trial registration ClinicalTrials.gov NCT04270422 , Registered on 17 February 2020, IRCT Identifier: IRCT20140810018754N11
... NSCLBP is no longer considered a purely structural, anatomical or biomechanical disorder of the lumbar spine. Instead, there are strong evidence that NSCLBP is associated with a complex interaction of factors involve structural or biomechanical, cognitive (eg, unhelpful beliefs, catastrophizing, maladaptive coping strategies, low self-e cacy), psychological (eg, fear, anxiety, depression), Lifestyle (eg, immobility, sleep problems) and social (eg, work and family issues) factors (1,8,(10)(11)(12)(13). Consequently, NSCLBP treatment guidelines generally acknowledge a shift from biomedical models to the biopsychosocial model. ...
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Full-text available
Background: Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on biopsychosocial approach compared to usual care physiotherapy, on clinical findings and Electroencephalography spectrum in non-specific chronic low back pain. Methods: This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4-months follow-up. 70 NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy), each group will receive 6-weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion and psychosocial correlates. Assessment will be performed at baseline, post-treatment and at 1- and 4-months follow-up. Discussion: Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain. Trial registration: ClinicalTrials.gov Identifier: NCT04270422, Registered 17 February 2020, https://clinicaltrials.gov/ct2/show/NCT04270422?term=NCT04270422&draw=2&rank=1 IRCT Identifier: IRCT20140810018754N11
... [1] There is interplay of multiple causative factors involved in perpetuation of chronic low back painphysical factors, cognitive factors, psychological factors, lifestyle factors and neurophysiological factors. [2][3][4] This in turn has an effect on performance of activities of daily living leading to disability and reduced quality of life. [5,6] Factors predicting disability not only include pain but also the psychosocial factors like kinesiophobia, activity avoidance behaviour, and beliefs. ...
Article
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[(Persian)]. AbSTrACT Aims and background: Neck pain is one of the most common problems in human societies. There are many factors involved in the etiology of neck pain, and cognitive problems related to pain are among the most important factors involved for non-specific neck pain. The aim of this study was to investigate the effect of six weeks of functional cognitive training on the pain intensity, disability and Kinesiophobia in people with non-specific chronic neck pain. Material and Methods: The present study was a clinical trial study with one intervention group and one control group. In this clinical trial study, 24 patients with chronic neck pain were randomly divided into two groups of Cognitive Functional Exercise (n=12) and Control (n=12). The variables of pain intensity, disability, and Kinesiophobia were evaluated before and immediately after six weeks of cognitive exercises by the Visual Analog Scale, neck disability questionnaire, and Tampa Scale of Kinesiophobia, respectively. Data were analyzed using Repeated Measures ANOVA and paired t-test. results: Comparing the two groups after treatment, there was a significant difference in pain intensity (P =0.001), disability index (P = 0.001), and Tampa Scale of Kinesiophobia (P = 0.001) was observed, so that in the intervention group in all factors a significant decrease was observed. Also, the results of the T-pair test showed that there is a significant difference in the group of intervention before and after the test in all variables (P = 0.001). But there was no significant difference for the control group. Conclusion: The findings showed that the intervention of functional cognitive exercises improves pain, disability, and Kinesiophobia in people with chronic neck pain, so it is suggested that functional cognitive exercises can be used as a complementary method in improving individuals with non-specific chronic neck pain.
Article
Resumen Antecedentes El dolor crónico afecta a alrededor de un 20% de la población en países desarrollados. Uno de cada cinco europeos lo sufre, alterando la vida del individuo, deteriorando su salud y siendo fuente de discapacidad. Existe una mayor incidencia del dolor crónico sobre el sexo femenino y la zona lumbar. Actualmente, la fisioterapia propone como tratamientos la educación en neurociencia del dolor (PNE) y el ejercicio terapéutico (TE). Objetivo Valorar la efectividad de la PNE aislada o combinada con TE respecto al dolor y sus variables clínicas más relevantes en pacientes con dolor lumbar crónico (CLBP). Material y métodos Se realizó una revisión sistemática en las bases de datos PubMed, Cochrane Library, ScienceDirect, Web of Science y Scopus entre enero y marzo del 2020. Se incluyeron ensayos clínicos aleatorizados (RCT) con seis o más puntos en la escala PEDro, publicados en 2004 o posterior con participantes mayores de 18 años diagnosticados con CLBP de tres o más meses de duración, sin dolor secundario a cirugías, cáncer o fracturas. Resultados Se seleccionaron ocho artículos. Tres ensayos concluyen que la PNE en solitario es efectiva a corto plazo, reduciendo la intensidad de dolor, uno la discapacidad y dos la kinesiofobia. Dos de ellos muestran que el TE es eficaz disminuyendo la intensidad del dolor y la discapacidad, y uno la kinesiofobia a corto y mediano plazo. Conclusión Parece ser que la PNE en solitario obtiene resultados significativos a corto plazo que no se mantienen en el tiempo. En el caso de PNE junto a TE la mejoría es más lenta, pero tiende a mantenerse a largo plazo. La intervención conjunta parece ser más efectiva. Una correcta diferenciación de las características de cada paciente y la individualización del tratamiento aumentan la efectividad de las intervenciones.
Article
Objective This study aims to investigate the efficacy of cognitive functional therapy (CFT) compared to core training exercise (CTE) on pain and specific disability of patients with failed back surgery syndrome (FBSS). Design This will be a randomized controlled clinical trial of two groups with blinded evaluators. Setting The study will be conducted at the Federal University of Santa Catarina (UFSC) and a private clinic in Florianópolis, SC, Brazil. Participants A total of 80 participants, of both sexes, with FBSS. Intervention Subjects will be randomized into two groups: one group receiving CFT or CTE. Individuals will be assisted once a week, for a maximum period of 12 weeks, with four being the minimum number of visits and 12 being the maximum number of visits. Measure ments: The primary outcomes will be pain and specific disability. Conclusions This is the first study investigating whether CFT is efficacious for patients with FBSS and chronic low back pain. The study's sample size was calculated to detect the effect of clinically relevant treatment with a low risk of bias. This clinical trial was designed to be able to reproduce an approach as a physiotherapist trained in CFT would do. That is, in a pragmatic way, increasing the significance of this study. CTE comprises a strategy widely used by physiotherapists to treat low back pain. Given that the scientific evidence of its efficacy for pain management is limited, the findings of this study will assist physiotherapists in their clinical decision-making.
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In this article, we attempt to distinguish between the properties of moderator and mediator variables at a number of levels. First, we seek to make theorists and researchers aware of the importance of not using the terms moderator and mediator interchangeably by carefully elaborating, both conceptually and strategically, the many ways in which moderators and mediators differ. We then go beyond this largely pedagogical function and delineate the conceptual and strategic implications of making use of such distinctions with regard to a wide range of phenomena, including control and stress, attitudes, and personality traits. We also provide a specific compendium of analytic procedures appropriate for making the most effective use of the moderator and mediator distinction, both separately and in terms of a broader causal system that includes both moderators and mediators. (46 ref) (PsycINFO Database Record (c) 2012 APA, all rights reserved)
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It has been proposed that patients with chronic non-specific low back pain (CNSLBP) can be broadly classified based on clinical features that represent either predominantly a mechanical pain (MP) or non-mechanical pain (NMP) profile. The aim of this study was to establish if patients with CNSLBP who report features of NMP demonstrate differences in pain thresholds compared to those who report MP characteristics and pain free controls. This study was a cross sectional design investigating whether pressure pain threshold (PPT) and/or cold pain threshold (CPT) at three anatomical locations differed between patients with mechanical CNSLBP (n = 17) versus non-mechanical CNSLBP (n = 19 and healthy controls (n = 19) whilst controlling for confounders. The results of this study provide evidence of increased CPT at the wrist in the NMP profile group compared to both the MP profile and control subjects, when controlling for gender, sleep and depression (NMP vs MP group Odds Ratio (OR):18.4, 95% CI:2.5 to 133.1, p=0.004). There was no evidence of lowered PPT at any site after adjustment for confounding factors. Those with a MP profile had similar pain thresholds to pain free controls, whereas the NMP profile group demonstrated elevated CPT’s consistent with central amplification of pain. These findings may represent different pain mechanisms associated with these patient profiles and may have implications for targeted management.
Article
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Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared 'natural history', enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design.
Article
The aims of this study were to evaluate health-related quality of life (HRQoL) in individuals with long-term, non-specific neck pain before and after treatment with qigong versus exercise therapy and to compare their HRQoL with an age and sex-matched reference population. A total of 122 persons were randomly assigned to either qigong or exercise therapy. HRQoL was measured with the 36-item Short Form Health Survey (SF-36) and pain intensity was assessed with a visual analogue scale (VAS) before and immediately after treatment, and at 12-month follow-up. Both treatment groups improved on all subscales; however, no differences were observed between the treatment groups either before or after treatment. Those who experienced pain relief (at least 10 mm change on VAS; 53%) also significantly improved from baseline on all SF-36 subscales. Persons with chronic neck pain had significantly lower scores on all SF-36 subscales than normative reference values both before and after treatment. The results of this study indicate no differences between qigong and exercise therapy in HRQoL outcome; however, broad HRQoL improvements seem to be contingent on significant pain reduction. As pain reduction was achieved in roughly half of the study group, more work is needed to refine these therapies, to identify neck pain persons most likely to benefit from them and to develop other physiotherapy treatment strategies suitable to non-responders.
Article
Evidence suggests that brief physiotherapy programmes are as effective for acute whiplash-associated disorders as more comprehensive programmes; however, whether this also holds true for chronic whiplash-associated disorders is unknown. We aimed to estimate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with advice in people with a chronic whiplash-associated disorder. PROMISE is a two group, pragmatic randomised controlled trial in patients with chronic (>3 months and <5 years) grade 1 or 2 whiplash-associated disorder. Participants were randomly assigned by a computer-generated randomisation schedule to receive either the comprehensive exercise programme (20 sessions) or advice (one session and telephone support). Sealed opaque envelopes were used to conceal allocation. The primary outcome was pain intensity measured on a 0-10 scale. Outcomes were measured at baseline, 14 weeks, 6 months, and 12 months by a masked assessor. Analysis was by intention to treat, and treatment effects were calculated with linear mixed models. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000825257. 172 participants were allocated to either the comprehensive exercise programme (n=86) or advice group (n=86); 157 (91%) were followed up at 14 weeks, 145 (84%) at 6 months, and 150 (87%) at 12 months. A comprehensive exercise programme was not more effective than advice alone for pain reduction in the participants. At 14 weeks the treatment effect on a 0-10 pain scale was 0·0 (95% CI -0·7 to 0·7), at 6 months 0·2 (-0·5 to 1·0), and at 12 months -0·1 (-0·8 to 0·6). CNS hyperexcitability and symptoms of post-traumatic stress did not modify the effect of treatment. We recorded no serious adverse events. We have shown that simple advice is equally as effective as a more intense and comprehensive physiotherapy exercise programme. The need to identify effective and affordable strategies to prevent and treat acute through to chronic whiplash associated disorders is an important health priority. Future avenues of research might include improving understanding of the mechanisms responsible for persistent pain and disability, investigating the effectiveness and timing of drugs, and study of content and delivery of education and advice. The National Health and Medical Research Council of Australia, Motor Accidents Authority of New South Wales, and Motor Accident Insurance Commission of Queensland.
Article
Background Classification schemas for low back pain (LBP), such as the Treatment Based Classification and the Movement System Impairment schemas, use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes. Purpose To assess if providing matched treatments based on patient specific clinical features led to superior treatment outcomes compared to an unmatched treatment for subjects with chronic, recurrent LBP. Study Design A randomized controlled trial. Patient Sample Subjects (n=124) with LBP (≥ 12 months) with or without recurrences underwent a standardized clinical exam to group them into one of 2 strata: (1) ineligible or (2) eligible for stabilization exercises based on the Treatment Based Classification schema. Subjects underwent additional clinical tests to assign them to one of the 5 possible Movement System Impairment categories. Outcome Measures Questionnaires were collected electronically at: Week 0, prior to treatment; Week 7 (following the 6 weekly, one hour treatment sessions); and 12 months. Using the Oswestry Disability Index (0-100) and the Numeric Pain Rating Scale (0-10), the primary analysis was performed using the intention-to-treat principle. Secondary outcomes included fear-avoidance beliefs as well as psychosocial, work related and general health status. Methods After subjects were categorized based on their particular clinical features using both the Treatment Based Classification and Movement System Impairment schemas, they were randomized into one of two treatments using a 3:1 ratio for matched or unmatched treatments. The treatments were (1) trunk stabilization exercise, or (2) Movement System Impairment-directed exercises. The study was funded by National Institutes of Health (NCMRR/R01HD040909; $1,485,000). There are no study specific conflicts of interest to report. Results Of the patients allocated to treatment for this study, 76 received a matched treatment and 25 received an unmatched treatment. Following treatment, both groups showed a statistically significant improvement in the primary outcome measures and almost all of the secondary measures; however, the matched treatment group did not demonstrate superior outcomes at Week 7 or 12 months, except on one of the secondary measures (Graded Chronic Pain Scale – Disability Scale) (P=0.01). Conclusion Providing a matched treatment based on either the Treatment Based Classification or the Movement System Impairment classification schemas did not improve treatment outcomes compared to an unmatched treatment for patients with chronic LBP, except on one secondary disability measure.
Article
Psychological factors are believed to influence the development of chronic low back pain. To date it is not known how fear avoidance beliefs influence the treatment efficacy in low back pain. To summarize the evidence examining the influence of fear avoidance beliefs measured with the Fear Avoidance Beliefs Questionnaire (FABQ) or the Tampa Scale of Kinesiophobia (TSK) on treatment outcomes in patients with low back pain. Systematic Review. Patients with low back pain. Work related outcomes and perceived measures including return to work, pain and disability METHODS: In January 2013, the following databases were searched: BIOSIS, CINAHL, Cochrane Library, Embase, OTSeeker, PeDRO, PsycInfo, PubMed/Medline, Scopus and Web of Science. A hand search of the six most often retrieved journals and a bibliography search completed the search. Study eligibility criteria, participants, and interventions: Research studies that included patients with low back pain who participated in randomized controlled trials (RCTs) investigating non-operative treatment efficacy. Out of 646 records 78 papers were assessed in full-text and 17 RCTs were included. Study quality was high in five studies, moderate in 12 studies. This study was not funded and the authors have no conflict of interest to declare. In patients with low back pain of up to six months duration, high fear avoidance beliefs were associated with more pain and / or disability (four RCTs) and less return to work (three RCTs) (GRADE high quality evidence, 831 patients vs. 322 in non-predictive studies). A decrease in fear avoidance beliefs values during treatment was associated with less pain and disability at follow-up (GRADE moderate evidence, two RCTs with moderate quality, 242 patients). Interventions that addressed fear avoidance beliefs were more effective than control groups based on biomedical concepts (GRADE moderate evidence, 1051 vs. 227 patients in studies without moderating effects). In chronic patients with LBP, the findings were less consistent. Two studies found baseline fear avoidance beliefs to be associated with more pain and disability and less RTW (339 patients) while three others (832 patients) found none (GRADE low evidence). Heterogeneity of the studies impeded a pooling of the results. Evidence suggests that fear avoidance beliefs are associated with poor treatment outcome in patients with LBP of less than six months and thus early treatment, including interventions to reduce fear avoidance beliefs, may avoid delayed recovery and chronicity. Patients with high fear avoidance beliefs are more likely to improve when fear avoidance beliefs are addressed in treatments than when these beliefs are ignored, and treatment strategies should be modified if fear avoidance beliefs are present.
Article
Psychological factors including catastrophizing thoughts are believed to influence the development of chronic low back pain. To assess the prognostic importance of catastrophizing as a coping strategy in patients with low back pain. Systematic Review PATIENT SAMPLE: Patients with low back pain. Work related outcomes and perceived measures including return to work, pain and disability. In September 2012, the following databases were searched: BIOSIS, CINAHL, Cochrane Library, Embase, OTSeeker, PeDRO, PsycInfo, Medline, Scopus, and Web of Science. To ensure completeness of the search, a hand search and a search of bibliographies was conducted and all relevant references included. All observational studies investigating the prognostic value of catastrophizing in patients with low back pain were eligible. Included were studies with 100 and more patients and follow-up of at least three months. Excluded were studies with poor methodological quality, short follow-up duration, and small sample size. This study was not funded and the authors have no conflict of interest to declare. 1473 references were retrieved, and 706 references remained after the removal of duplicates. For 77 references, the full text was assessed and 19 publications based on 16 studies were included. Of four studies that investigated work-related outcomes, two found catastrophizing to be associated with work status. Most studies that investigated self-reported outcome measures (n= 8, 66%) found catastrophizing to be associated with pain and disability at follow-up in acute, subacute, and chronic low back pain patients. In most studies that applied cut-off values, patients identified as high catastrophizers experienced a worse outcome compared to low catastrophizers (n=5, 83%). There is some evidence that catastrophizing as a coping strategy might lead to delayed recovery. The influence of catastrophizing in patients with low back pain is not fully established and should be further investigated. Of particular importance is the establishment of cut-off levels for identifying patients at risk.