Health Effects of Mindfulness Based Stress Reduction Course in Treatment of Back Pain

April 7, 2026 updated by: Tampere University Hospital

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

  • 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jenna Sisouno Researcher, M.D., Pediatric surgeon
  • Phone Number: 01041400
  • Email: jennasisouno@gmail.com

Study Contact Backup

  • Name: Jussi Repo Study director, PhD, M.D. orthopedical surgeon
  • Phone Number: 090030000
  • Email: jussi.repo@pirha.fi

Study Locations

  • Finland
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
        • Contact:
          • Jussi Repo Study director, Phd, MD, orthopedical surgeon
          • Phone Number: 090030000
          • Email: jussi.repo@pirha.fi
        • Contact:
      • Tampere, Finland
        • Recruiting
        • Mehilainen
        • Contact:
      • Tampere, Finland
        • Recruiting
        • Pirte
        • Contact:
          • Teija Mertimo Phd, occupational health, Phd, occupational health
          • Phone Number: 0356564600
          • Email: teija.mertimo@pirte.fi
      • Tampere, Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MBSR intervention
Behavioral: Mindfulness based stress reduction (MBSR) course
8-week mindfulness course lead by psychologist, psychotherapist
No Intervention: Control group with usual care for back pain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale
Time Frame: 2 years
0 (no pain), 10 (worst imaginable pain)
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total patient-experienced pain interference
Time Frame: 2 years
0 (no interference), 10 (worst imaginable interference)
2 years
Claudication distance
Time Frame: 2 years
2 years
Radiculative symptoms
Time Frame: 2 years
2 years
Multiple pain in other areas
Time Frame: 2 years
Localized pain in other areas of the (head, neck and shoulders, arms, legs, abdomen, chest, no pain in other parts of the body)
2 years
Amount of physiotherapy contacts
Time Frame: 2 years
Amount of physiotherapy contacts before the study (during previous 3 months) and contacts between the survey points
2 years
Amount of mental health contacts
Time Frame: 2 years
Amount of mental health (psychiatrist, psychologist, nurse) contacts before the study (during previous 3 months) and contacts between the survey points
2 years
Amount of sick leave
Time Frame: 2 years
Amount of sick leave (in days) in the start point (during previous 3 months) and between the survey points
2 years
Burnout assessement tool (BAT-12)
Time Frame: 2 years
2 years
GAD-7
Time Frame: 2 years
2 years
BDI-2
Time Frame: 2 years
2 years
EQ-5D-5L
Time Frame: 2 years
2 years
ODI
Time Frame: 2 years
2 years
Consumption of alcohol
Time Frame: 2 years
Consumptions of alcohol portions during the last week (1 portion is 1 beer (33 cl), 1 glass of wine (12 cl), 4 cl of distilled spirits).
2 years
Sleeping problems
Time Frame: 2 years
Amount of nights with sleeping problems during the last week
2 years
Consumption of cigarettes
Time Frame: 2 years
Consumption of cigarettes per day
2 years
Body weight
Time Frame: 2 years
2 years
Physical acitivity
Time Frame: 2 years
Times of physical acitivity (over 30 minutes) per week
2 years
Consumption of painkillers
Time Frame: 2 years
Consumption of painkillers per week: paracetamol, NSAID, opioid
2 years
Consumption of antidepressants
Time Frame: 2 years
Consumption of antidepressants per day
2 years
Consumption of benzodiazepines
Time Frame: 2 years
Consumption of benzodiazepines per week (for sleep or/and anxiety)
2 years
Consumption of muscle relaxants
Time Frame: 2 years
Consumption of muscle relaxants per week
2 years
Experienced benefit from the MBSR- course
Time Frame: 2 years
0 (no benefit), 10 (the most imaginable benefit)
2 years
Complications of the intervention
Time Frame: 2 years
Experienced complications of the intervention (open text)
2 years
Experienced total work ability now
Time Frame: 2 years
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
2 years
Experienced mental work ability now
Time Frame: 2 years
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
2 years
Experienced physical work ability now
Time Frame: 2 years
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
2 years
Experienced total work ability after 2 years
Time Frame: 2 years
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
2 years
Experienced mental work ability after 2 years
Time Frame: 2 years
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
2 years
Experienced physical work ability after 2 years
Time Frame: 2 years
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
2 years
Previous psychological diagnoses
Time Frame: 2 years
Previous diagnosis in depression, anxiety disorder or burn-out
2 years
Rate of participation in MBSR course meetings
Time Frame: 2 years
Rate of participation in MBSR course meetings (only week 8), 0-9 (meetings)
2 years
Amount of daily mindfulness practice
Time Frame: 2 years
Amount of (daily 20 minutes, private) mindfulness practice during and after the course (daily, weekly, monthly, less, none)
2 years
Other received rehabilitation
Time Frame: 2 years
No, rehabilitation course, McKenzie therapy, TENS, manipulation or psychophysical physiotherapy for back pain
2 years
Amount of contacts to the doctor for back pain
Time Frame: 2 years
Amount of contacts to the doctor for back pain before (during previous 3 months) and between the survey points
2 years
Experienced calmness during the last week
Time Frame: 2 years
all the time, most of the time, sometimes, seldom, never
2 years
Experienced happiness during the last week
Time Frame: 2 years
all the time, most of the time, sometimes, seldom, never
2 years
Experienced state of feeling energetic during the last week
Time Frame: 2 years
all the time, most of the time, sometimes, seldom, never
2 years
Experienced contentment during the last week
Time Frame: 2 years
all the time, most of the time, sometimes, seldom, never
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tampere University
Pirte
Mehiläinen Tampere
Terveystalo Tampere

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jussi Repo, PhD, M.D. orthopedical surgeon, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R23051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

After publishing 2026

IPD Sharing Access Criteria

Open access publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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