Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Low Back Pain
  • Chronic Neck Pain
  • Insomnia Chronic
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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. Trea...

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.

Tracking Information

NCT #
NCT03482856
Collaborators
  • Vrije Universiteit Brussel
  • Universitair Ziekenhuis Brussel
  • University Hospital, Ghent
  • Research Foundation Flanders
Investigators
Principal Investigator: Barbara Cagnie, PhD University Ghent