Mindfulness-based stress reduction for chronic thoracic or lumbar back pain
Health Effects of Mindfulness Based Stress Reduction Course Versus Usual Care in Treatment of Back Pain: a Randomized Clinical Trial
This project will test whether an 8-week mindfulness-based stress reduction (MBSR) course helps working-age adults (18–64) with chronic thoracic or lumbar back pain reduce their pain compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 4 sites (Tampere and 3 other locations) |
| Trial ID | NCT07528833 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial will assign working-age adults with thoracic or lumbar back pain (pain >12 weeks, NRS ≥4) to either an 8-week MBSR course or usual care. The MBSR intervention is delivered over eight weeks and participants are followed for up to two years. The primary outcome is pain intensity measured by the 0–10 Numeric Rating Scale (NRS), and study data are collected via ReCare/REDCap systems. Recruitment requires Finnish language competence and excludes conditions such as pregnancy, recent delivery, acute severe back trauma or infection, recent or planned spinal surgery, psychosis, and spinal tumors.
Who should consider this trial
Good fit: Ideal candidates are Finnish-speaking adults 18–64 with thoracic or lumbar back pain lasting more than 12 weeks and an average pain score of at least 4 on the 0–10 numeric rating scale, with or without radicular symptoms.
Not a fit: Patients with recent childbirth, pregnancy, acute severe back trauma or infection, recent or planned back surgery, active psychotic symptoms, or spinal tumors are unlikely to benefit from this intervention or are excluded from participation.
Why it matters
Potential benefit: If successful, MBSR could reduce pain intensity and improve daily function for people with chronic back pain, potentially lowering reliance on medications or invasive treatments.
How similar studies have performed: Prior clinical studies of mindfulness-based programs for chronic low back pain have shown modest to moderate improvements in pain and function, so this approach has some supporting evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Working-age (18-64 years) patients * Back pain in thoracal or lumbar area * NRS at least 4 * With or without radiculative symptoms * Pain duration over 12 weeks * Pain can be localized or widespread * Also patients with multiple pain are eligible * X-ray or MRI scan is not needed * Patients can be both gender * Finnish language skills and adequate competence are needed for filling the survey forms and participation in interventions Exclusion Criteria: * Pregnancy * Recent delivery (\<12 months) * Mental health problems with psychotic symptoms * Acute severe psychological trauma (3 months) * Sings of back infection * Acute severe trauma in the back (fracture) * surgery (\< 6 months) * planned surgery in the future * tumor in the back
Where this trial is running
Tampere and 3 other locations
- Mehilainen — Tampere, Finland (Recruiting)
- Pirte — Tampere, Finland (Recruiting)
- Tampere University hospital — Tampere, Finland (Recruiting)
- Terveystalo — Tampere, Finland (Recruiting)
Study contacts
- Study coordinator: Jenna Sisouno Researcher, M.D., Pediatric surgeon
- Email: jennasisouno@gmail.com
- Phone: 01041400
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.