Comparing Pain Reprocessing Therapy and Cognitive Behavioral Therapy for Chronic Back Pain
Feasibility and Acceptability of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
NA · University of Colorado, Denver · NCT05820204
This study is testing whether Pain Reprocessing Therapy works better than Cognitive Behavioral Therapy and regular care for adults with chronic back pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05820204 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Pain Reprocessing Therapy (PRT) compared to Cognitive Behavioral Therapy (CBT) and usual care in adults suffering from chronic back pain. The study will assess which treatment is more effective in reducing pain and improving related issues. It will involve a diverse population and utilize a remotely-delivered PRT intervention, addressing an urgent need for effective non-pharmacological treatments for chronic pain. The trial will also focus on the feasibility of recruiting and retaining participants from racially and ethnically diverse backgrounds.
Who should consider this trial
Good fit: Ideal candidates for this study are adults experiencing chronic back pain with an average pain level of at least 4 out of 10 over the past week.
Not a fit: Patients currently involved in litigation related to their pain or those with active psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for individuals suffering from chronic back pain.
How similar studies have performed: Previous studies have shown promising results for Pain Reprocessing Therapy, but this trial aims to explore its effectiveness in a more diverse population, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session) * Back pain that is an ongoing problem for at least half the days of the last 6 months * Back pain that is worse than leg pain. Exclusion Criteria: * Current litigation or compensation associated with pain or plans to apply for compensation or engage in litigation in the next 6 months * Active suicidal ideation with intent, recent history of suicide attempt, or recent history of suicide attempts or self-harm behaviors within the past 5 years (including non-suicidal self-harm) * Recent history of inpatient psychiatric hospitalization within the past 5 years * Active, current psychosis or mania * Active, current substance abuse, or problems with substance abuse within the past 2 years * Instability in living conditions or major interfering life events: * Major surgery or other major medical event planned in coming six months * Unsure whether will reliably have suitable conditions for telehealth appointments over the next two months, including a computer or tablet, reliable fast internet, and a quiet comfortable room that is reliably available. * Major, interfering changes in employment or housing anticipated over the next six months * Failure to complete at least 85% (6 of 7) of EMA surveys in the first week of the study (post-consent, pre-randomization) * Leg pain worse than back pain * Back surgery within the last 2 years * Difficulty controlling bladder function (to screen out cauda equina syndrome) * Serious medical illness (e.g., current, or recent cancer diagnosis, severe cardiovascular disease) * Recent large unexplained, unintended weight loss (20lbs or more) * Recent vertebral fracture/ known spinal fractures or tumors * Known sensory/motor abnormalities in the trunk or legs. * Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Jonathan K. Ashar, Ph.D. — University of Colorado, Denver
- Study coordinator: Jonathan K. Ashar, Ph.D.
- Email: yoni.ashar@cuanschutz.edu
- Phone: 303.724.2536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Chronic, Back Pain, chronic pain, Pain Reprocessing Therapy, Cognitive Behavioral Therapy for Chronic Pain