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ClinicalTrials.gov ID

NCT07528833

Lead Sponsor

Tampere University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Apr 14, 2026Actual

Start Date

Jan 1, 2025Actual

Primary Completion Date

Jan 1, 2030Estimated

Completion Date

Jan 1, 2030Estimated

Official Title

Health Effects of Mindfulness Based Stress Reduction Course Versus Usual Care in Treatment of Back Pain: a Randomized Clinical Trial

Brief Summary

• Health effects of mindfulness based stress reduction course versus usual care in treatment of back pain: a randomized clinical trial
• Mindfulness based stress reduction (MBSR) course intervention for half of the research patients
• MBSR course lasts for 8 weeks.
• follow-up time 2 years.
• research data is collected by Recdap
• Working-age (18-64 years) patients with back pain in thoracal or lumbar area (NRS at least 4) with or without radiculation over 12 weeks will be recruited.
• The primary outcome measure is Numeric pain rating scale (NRS, 0-10).

• Back Pain

• Mindfulness based stress reduction (MBSR) course

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

PirteUNKNOWN

Mehiläinen TampereUNKNOWN

Terveystalo TampereUNKNOWN

Tampere UniversityOTHER

teija.mertimo@pirte.fi0356564600

riina-riitta.helminen@terveystalo.com090030000