Clinical trial NCT03482856: Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain
Official title: Cognitive Behavioural Therapy for Insomnia in Patients With Chronic Spinal Pain: a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Chronic Neck Pain
Insomnia Chronic
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Universitair Ziekenhuis Brussel
name: University Hospital, Ghent
name: Research Foundation Flanders
First posted: 2018-03-29
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will randomize 120 patients with CSP and comorbid insomnia, aged between 18 and 65 years, to the experimental intervention (i.e. 18 sessions of the modern neuroscience approach combined with CBT-I, including 3 sessions of therapeutic pain neuroscience education, 6 sessions of CBT-I and 9 sessions of cognition-targeted exercise therapy, n=60) or the control intervention (i.e. 18 sessions of the modern neuroscience approach alone, including 3 sessions of therapeutic pain neuroscience education, and 15 sessions of cognition-targeted exercise therapy, n=60).
Primary purpose: TREATMENT

Brief summary: Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent and severely debilitating disorder characterized by tremendous personal and socioeconomic impact, long-term sick leave, low quality of life and very high socioeconomical costs. The current strategies for treating CSP are not yet optimal in reducing pain and related disability, urging the need for improvement. A possible problem is that the current approaches are often to limited and only address pain.

Current treatments for CSP do not address associated complaints like sleeping problems which are however important issues. If present, sleeping problems may contribute to CSP severity and related disability. If left untreated, they represent a barrier for effective CSP management. Up to now, however, sleeping problems are hardly addressed and if so, it is mostly limited to sleeping medication. This is a problem since the efficacy and safety of drug treatment has not been established.

Therefore, within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best physical therapy treatment for CSP. CBT-I includes changing negative thoughts about sleep, sleep hygiene, altering sleeping patterns, and teaching relaxation skills.

The objectives of the study are to examine if CBT-I combined with the modern physical therapy approach (education about pain followed by exercise therapy) is more effective than the modern physical therapy approach alone for reducing pain, improving sleep and functionality in CSP patients with sleeping problems.

Therefore 120 CSP patients with sleeping problems will be randomly divided over the 2 treatment programs (60 per group) and will be assessed before and after their 14-week therapy program consisting of 18 therapy sessions. Comparisons will be made for pain severity, sleep quality and functionality.

Detailed description: Modern pain neuroscience has advanced our understanding of chronic spinal pain (CSP). Despite the scientific progresses with regard to the treatment of chronic spinal pain (CSP), current treatments for CSP do not address pain comorbidities like insomnia, an important yet seldom addressed issue. Treatment of CSP mostly still relies on monotherapies or on biomedical models, as shown by expensive but ineffective treatments like lumbar fusion surgery, ignoring important comorbidities such as insomnia.

Within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best evidence treatment for CSP. The innovative nature of this approach to CSP goes well beyond the combination of 2 available and effective treatments: combining cognitive behavioral therapy for insomnia with the recently established modern neuroscience approach (pain neuroscience education followed by cognition-targeted exercise therapy) strengthens the content of both individual approaches and applies the current understanding regarding insomnia and pain neuroscience to clinical practice. This innovative combination will result in a synergistic effect of both treatments.

The primary scientific objective of the study is to examine if CBT-I combined with a modern neuroscience approach (pain neuroscience education followed by cognition-targeted exercise therapy) is more effective than the modern neuroscience approach alone for reducing pain in CSP patients with insomnia. Secondary objectives of the study are to examine if CBT-I combined with the modern neuroscience approach is more effective than the modern neuroscience approach alone for improving pain related outcomes, sleep related outcomes and physical activity/functionality in CSP patients with insomnia.

To comply with these scientific objectives, the 120 CSP patients with comorbid insomnia will be subjected to the baseline assessment of all outcome measures.

Follow-up assessments will be performed immediately after 14 weeks of therapy (all tests), and 3 months (questionnaires), 6 months (questionnaires) and 12 months (all tests, depending on a go/no go decision) after finishing the therapeutic intervention.

To investigate these objectives, a muli-center triple-blind randomized, controlled trial with 1 year follow up will be performed.

Appropriate statistical analyses will be performed to evaluate and compare treatment effects. Statistical, as well as clinical significant differences will be defined and the effect size will be determined.

Eligibility criteria: Inclusion Criteria:

* Nonspecific spinal pain for at least 3 months' duration, at least 3 days per week
* Seeking care because of neck pain or low back pain
* Native Dutch speaker
* Having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as \> 30 minutes of sleep latency and/or minutes awake after sleep onset for \> 3 days / week for \> 6 months
* Living or working within a radius of 50 km around the therapy location
* Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
* Refraining from analgesics, caffeine, alcohol or nicotine in the previous 48h of the assessments
* Nonspecific failed back surgery \> 3 years are permitted
* Not undertaking exercise (\> 3 metabolic Equivalents) 3 days before the assessments

Exclusion Criteria:

* Severe underlying sleep pathology (identified through baseline data of polysomnography)
* Neuropathic pain
* Chronic widespread pain
* Being pregnant or pregnancy (including given birth) in the preceding year
* History of specific spinal surgery
* Thoracic pain in absence of neck or low back pain
* Shift workers
* Diagnosed depression
* Body Mass Index below 30

Primary outcomes:
measure: Brief Pain Inventory (Numeric Rating Scale)
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Central Sensitization Inventory
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Pressure Pain Thresholds
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Polysomnography (PSG)
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up 12 months after the end of therapy. Polysomnography T4 assessment will be carried out based on a go/no go decision, if improvements are visible at the T1 assessment.
measure: Pittsburg Sleep Quality Index
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Insomnia Severity Index
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Epworth Sleepiness Scale
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Brugmann Fatigue Scale
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Hospital Anxiety and Depression rating scale
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Physical Activity using Actigraphy
timeFrame: 1 week at baseline, 1 week at T1 follow-up assessment after 14 weeks of therapy, 1 week at T4 follow-up assessment 12 months after the end of therapy
measure: Short Form Health Survey - 36 items Mental Health
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
measure: Short Form Health Survey - 36 items Physical Health
timeFrame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Brussels
state: Brussels Hoofdstedelijk Gewest
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Barbara Cagnie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nijs J, Meeus M, Cagnie B, Roussel NA, Dolphens M, Van Oosterwijck J, Danneels L. A modern neuroscience approach to chronic spinal pain: combining pain neuroscience education with cognition-targeted motor control training. Phys Ther. 2014 May;94(5):730-8. doi: 10.2522/ptj.20130258. Epub 2014 Jan 30.
citation: Nijs J, Mairesse O, Neu D, Leysen L, Danneels L, Cagnie B, Meeus M, Moens M, Ickmans K, Goubert D. Sleep Disturbances in Chronic Pain: Neurobiology, Assessment, and Treatment in Physical Therapist Practice. Phys Ther. 2018 May 1;98(5):325-335. doi: 10.1093/ptj/pzy020.
citation: Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.
citation: Malfliet A, Kregel J, Meeus M, Cagnie B, Roussel N, Dolphens M, Danneels L, Nijs J. Applying contemporary neuroscience in exercise interventions for chronic spinal pain: treatment protocol. Braz J Phys Ther. 2017 Sep-Oct;21(5):378-387. doi: 10.1016/j.bjpt.2017.06.019. Epub 2017 Jul 8.
citation: Malfliet A, Bilterys T, Van Looveren E, Meeus M, Danneels L, Ickmans K, Cagnie B, Mairesse O, Neu D, Moens M, Goubert D, Kamper SJ, Nijs J. 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. Braz J Phys Ther. 2019 Jan-Feb;23(1):62-70. doi: 10.1016/j.bjpt.2018.10.007. Epub 2018 Oct 29.