An interventional study of MNA plus CBT-I and MNA alone in Chronic Low Back Pain, Chronic Neck Pain and Insomnia Chronic, sponsored by University Ghent. Completed at 2 sites in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
MNA (i.e. modern pain neuroscience approach) combined with CBT-I (i.e. cognitive-behavioural therapy for insomnia)
Behavioral: MNA plus CBT-I
The MNA (i.e. modern pain neuroscience approach) alone
Behavioral: MNA alone
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.
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.
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.
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
Brief Pain Inventory
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.
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
Central Sensitization Inventory
Change in self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
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
Pressure Pain Thresholds
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).
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
Polysomnography (PSG)
Change in polysomnography. Participants will be monitored in the comfort of their own home by ambulatory 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.
Pittsburg Sleep Quality Index
Change in self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.
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
Insomnia Severity Index
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.
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
DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)
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.
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
Epworth Sleepiness Scale
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.
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
Brugmann Fatigue Scale
Change in self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
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
Hospital Anxiety and Depression rating scale
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.
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
Physical Activity using Actigraphy
Change in physical activity: Continuous assessment of physical activity and rest/activity cycles
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
Short Form Health Survey - 36 items Mental Health
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.
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
Short Form Health Survey - 36 items Physical Health
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.
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
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