Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain

NCT03482856 | Completed

• 1 other identifier: EC/2018/0277
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low Back Pain; Chronic Neck Pain; Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (Numeric Rating Scale)

  Change in self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.

  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 (13)

• Brief Pain Inventory

  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

• Central Sensitization Inventory

  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

• Pressure Pain Thresholds

  Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up assessment 12 months after the end of therapy

• Polysomnography (PSG)

  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.

• Pittsburg Sleep Quality Index

  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

Study Arms (2)

Modern Neuroscience Approach (MNA) plus CBT-I

EXPERIMENTAL

MNA (i.e. modern pain neuroscience approach) combined with CBT-I (i.e. cognitive-behavioural therapy for insomnia)

Behavioral: MNA plus CBT-I

MNA alone

ACTIVE COMPARATOR

The MNA (i.e. modern pain neuroscience approach) alone

Behavioral: MNA alone

Interventions

MNA plus CBT-I BEHAVIORAL

MNA plus CBT-I includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, 6 individual sessions of CBT-I and 9 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. CBT-I is the standard evidence-based care for treating chronic primary insomnia and typically includes changing negative thoughts about sleep, sleep hygiene, sleep restriction therapy, and teaching relaxation skills. The 18 sessions will be spread over a period of 14 weeks.

Modern Neuroscience Approach (MNA) plus CBT-I

MNA alone BEHAVIORAL

MNA alone includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, and 15 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. The 18 sessions will be spread over a period of 14 weeks.

MNA alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Vrije Universiteit Brussel: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• University Hospital, Ghent: collaborator
• Research Foundation Flanders: collaborator

Study Sites (2)

University Hospital Brussels

Brussels, Brussels Capital, 1090, Belgium

Location

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (6)

• 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.

  PMID: 24481595 BACKGROUND

• 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.

  PMID: 29425327 BACKGROUND

• 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.

  PMID: 25090974 BACKGROUND

• 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.

  PMID: 28736211 BACKGROUND

• Malfliet A, De Baets L, Bilterys T, Van Looveren E, Mairesse O, Cagnie B, Meeus M, Moens M, Goubert D, Munneke W, Daneels L, Ickmans K, Kamper S, Nijs J. Cognitive Behavioral Therapy for Insomnia in Pain Management for Nonspecific Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425856. doi: 10.1001/jamanetworkopen.2024.25856.

  PMID: 39120902 DERIVED

• 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.

  PMID: 30389347 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Barbara Cagnie, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 29, 2018
• Study Start: March 29, 2018
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

BE (2)