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Vol. 23. Issue 1.
Pages 62-70 (01 January 2019)
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Vol. 23. Issue 1.
Pages 62-70 (01 January 2019)
Clinical Trial Protocol
DOI: 10.1016/j.bjpt.2018.10.007
The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial
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Anneleen Malflieta,b,c,d,e,
Corresponding author
Anneleen.Malfliet@vub.be

Corresponding author at: Vrije Universiteit Brussel, Brussels Health Campus, Building F-Kine, Laarbeeklaan 103, BE-1090 Brussels (Jette), Belgium.
, Thomas Bilterysb,c, Eveline Van Looverenb,e, Mira Meeuse, Lieven Danneelse, Kelly Ickmansb,c,d, Barbara Cagniee, Olivier Mairessei,j, Daniel Neuj, Maarten Moensf,g,h, Dorien Goubertb,e, Steven J. Kamperk,l, Jo Nijsb,c,d
a Research Foundation – Flanders (FWO), Brussels, Belgium
b Pain in Motion International Research Group1
c Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium
d Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels Belgium
e Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Campus Heymans, Ghent, Belgium
f Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium
g Department of Radiology, Universitair Ziekenhuis Brussel, Brussels, Belgium
h Center for Neurosciences (C4N), Vrije Universiteit Brussel (VUB), Brussels, Belgium
i Department of Experimental and Applied Psychology, Vrije Universiteit Brussel, Brussels, Belgium
j Sleep Laboratory and Unit for Chronobiology U78, Brugmann University Hospital, Université Libre de Bruxelles (U.L.B.), Brussels, Belgium
k School of Public Health, University of Sydney, Camperdown, Australia
l Centre for Pain, Health and Lifestyle, Sydney, Australia2
Highlights

  • There is a close interaction between insomnia and pain severity/disability.

  • CBT-I can improve sleep and pain interference in chronic spinal pain.

  • Clinical implication 1: combined approach may improve pain, sleep and function.

  • Clinical implication 2: may lead to new treatment guidelines for professionals.

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Table 1. In- and exclusion criteria.
Table 2. Organization of therapeutic sessions.
Table 3. Content of the sleep management program.
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Abstract
Background

Insomnia is a highly prevalent and debilitating comorbidity that is often not addressed in therapy for chronic spinal pain (CSP). Given the close interaction between insomnia and CSP severity and related disability, targeting sleep problems during therapy could improve treatment outcomes in these patients.

Objective

Can cognitive behavioral therapy for insomnia (CBT-I) combined with the modern neuroscience approach (i.e. pain neuroscience education and cognition-targeted exercise therapy) reduce pain and improve sleep, physical activity and function in people with CSP and comorbid insomnia?

Methods

Participants: One-hundred-twenty participants with chronic spinal pain and comorbid insomnia Intervention: CBT-I combined with the modern neuroscience approach (experimental) compared to the modern neuroscience approach alone (control). Both interventions start with three sessions of pain neuroscience education, followed by six sessions of CBT-I and nine sessions of cognition-targeted exercise therapy in the experimental group, or 15 sessions of cognition-targeted exercise therapy in the control group.

Measurements

Primary outcome measure: self-reported pain severity (Brief Pain Inventory). Secondary outcome measures: pain sensitivity (pressure pain thresholds, and online questionnaires), sleep-related outcomes (home-based polysomnography and online questionnaires), physical activity (actigraphy), and function (online questionnaires). Online questionnaires will be completed at baseline, directly post-treatment, and at 3, 6 and 12 months post-treatment. Polysomnography, pressure pain thresholds and actigraphy will be carried out at baseline, post-treatment and at 12 months follow-up.

Discussion

Findings may provide (1) a novel therapeutic approach for people with CSP and comorbid insomnia to improve pain, sleep, physical activity and function, and (2) new treatment guidelines for professionals.

Trial registration

Clinicaltrials.gov NCT03482856 (https://clinicaltrials.gov/ct2/show/NCT03482856).

Keywords:
Chronic pain
Low back pain
Neck pain
Randomized controlled trial

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