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Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain

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ClinicalTrials.gov Identifier: NCT03482856
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
Vrije Universiteit Brussel
Universitair Ziekenhuis Brussel
University Hospital, Ghent
Research Foundation Flanders
Information provided by (Responsible Party):
University Ghent

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Chronic Neck Pain Insomnia Chronic Behavioral: MNA plus CBT-I Behavioral: MNA alone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioural Therapy for Insomnia in Patients With Chronic Spinal Pain: a Multi-center Randomized Controlled Trial
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Modern Neuroscience Approach (MNA) plus CBT-I
MNA (i.e. modern pain neuroscience approach) combined with CBT-I (i.e. cognitive-behavioural therapy for insomnia)
Behavioral: MNA plus CBT-I
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.

Active Comparator: MNA alone
The MNA (i.e. modern pain neuroscience approach) alone
Behavioral: MNA alone
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.




Primary Outcome Measures :
  1. Brief Pain Inventory (Numeric Rating Scale) [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: 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 ]
    Change in self-reported impact of pain on functioning. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain or higher interference of pain in daily life.

  2. Central Sensitization Inventory [ Time Frame: 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 ]
    Change in self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.

  3. Pressure Pain Thresholds [ Time Frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up assessment 12 months after the end of therapy ]
    Change in Pressure Pain Thresholds at measured bilaterally with a digital pressure algometer (Wagner Instruments), both at symptomatic levels (trapezius muscle and 5 centimetres lateral to the spinous process of L3) and at remote sites (i.e. secondary hyperalgesia).

  4. Polysomnography (PSG) [ Time Frame: 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. ]
    Change in polysomnography. Participants will be monitored in the comfort of their own home by ambulatory PSG.

  5. Pittsburg Sleep Quality Index [ Time Frame: 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 ]
    Change in self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.

  6. Insomnia Severity Index [ Time Frame: 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 ]
    Change in self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.

  7. DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep) [ Time Frame: 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 ]
    Change in self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep.

  8. Epworth Sleepiness Scale [ Time Frame: 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 ]
    Change in self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.

  9. Brugmann Fatigue Scale [ Time Frame: 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 ]
    Change in self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.

  10. Hospital Anxiety and Depression rating scale [ Time Frame: 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 ]
    Change in self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety.

  11. Physical Activity using Actigraphy [ Time Frame: 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 ]
    Change in physical activity: Continuous assessment of physical activity and rest/activity cycles

  12. Short Form Health Survey - 36 items Mental Health [ Time Frame: 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 ]
    Change in self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health.

  13. Short Form Health Survey - 36 items Physical Health [ Time Frame: 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 ]
    Change in self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482856


Contacts
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Contact: Anneleen Malfliet, MSc 003224774562 anneleen.malfliet@vub.be

Locations
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Belgium
University Hospital Brussels Recruiting
Brussels, Brussels Hoofdstedelijk Gewest, Belgium, 1090
Contact: Jo Nijs, PhD       jo.nijs@vub.be   
University Hospital Ghent Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Barbara Cagnie, PhD       barbara.cagnie@ugent.be   
Sponsors and Collaborators
University Ghent
Vrije Universiteit Brussel
Universitair Ziekenhuis Brussel
University Hospital, Ghent
Research Foundation Flanders
Investigators
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Principal Investigator: Barbara Cagnie, PhD University Ghent

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03482856     History of Changes
Other Study ID Numbers: EC/2018/0277
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Sleep Initiation and Maintenance Disorders
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders