Status:
COMPLETED
Resilience Skills Self-Management for Chronic Pain.
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Chronic Spine Pain
Fibromyalgia
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-managemen...
Eligibility Criteria
Inclusion
- Primary back or spine pain diagnosis from the Back \& Pain Center at University of Michigan.
- High scores on the 2011 survey criteria for Fibromyalgia. The survey criteria for FM consist of an assessment of widespread pain and symptom severity.
Exclusion
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus.
- Medical conditions that can impair health status independent of spine pain and FM, including cardiopulmonary disorders (e.g. CHF, COPD), uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes), or malignancy within the preceding 2 years
- Current psychotic disorder (schizophrenia, etc.), dissociative identity disorder, untreated bipolar disorder, active suicide risk, or current alcohol / drug dependence.
- Planned major surgery in the next 12 months;
- Pregnancy or taking steroid medications
- Recent pain interventions ≤6 weeks prior to study (e.g., back surgery, epidural steroid injections) or planned interventions for the study period (e.g., surgery scheduled). Ongoing physical therapy will be allowed and new physical therapy or exercise regimen will be addressed during data analysis;
- Cognitive impairment or dementia (inability to give consent or meaningfully participate);
- Pending or recently received (within 1 years) pain-related disability or Workman's Compensation;
- Unable to read or fluently converse in English;
- Planning to move from the area in next 14 months;
- In the judgment of the PIs the individual would not be able to meaningfully participant.
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03304613
Start Date
November 16 2017
End Date
March 21 2023
Last Update
November 18 2023
Active Locations (1)
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1
Back & Pain Center, University of Michigan
Ann Arbor, Michigan, United States, 48106