NCT07528833

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
43mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2025Jan 2030

Study Start

First participant enrolled

January 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

March 30, 2026

Last Update Submit

April 7, 2026

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

  • Numeric pain rating scale

    0 (no pain), 10 (worst imaginable pain)

    2 years

Secondary Outcomes (38)

  • Total patient-experienced pain interference

    2 years

  • Claudication distance

    2 years

  • Radiculative symptoms

    2 years

  • Multiple pain in other areas

    2 years

  • Amount of physiotherapy contacts

    2 years

  • +33 more secondary outcomes

Study Arms (2)

MBSR intervention

EXPERIMENTAL
Behavioral: Mindfulness based stress reduction (MBSR) course

Control group with usual care for back pain

NO INTERVENTION

Interventions

Mindfulness based stress reduction (MBSR) courseBEHAVIORAL

8-week mindfulness course lead by psychologist, psychotherapist

MBSR intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mehilainen

Tampere, Finland

RECRUITING

Pirte

Tampere, Finland

RECRUITING

Tampere University hospital

Tampere, Finland

RECRUITING

Terveystalo

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Back Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jussi Repo, PhD, M.D. orthopedical surgeon

    Tampere University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jenna Sisouno Researcher, M.D., Pediatric surgeon

CONTACT

01041400jennasisouno@gmail.com

Jussi Repo Study director, PhD, M.D. orthopedical surgeon

CONTACT

090030000jussi.repo@pirha.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: MBSR versus control group with usual care for back pain
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 14, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
After publishing 2026
Access Criteria
Open access publication

Locations

FI(4)