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

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: Recruiting
• Conditions: Back Pain
• Intervention / Treatment: Behavioral: Mindfulness based stress reduction (MBSR) course

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Jenna Sisouno Researcher, MD, pediatric surgeon; Phone Number: 01041400; Email: jennasisouno@gmail.com
  • Tampere, Finland
    • Recruiting
    • Mehilainen
    • Contact: Kaisla Lahdensuo Phd, psychiatrician, Phd, psychiatrician; Phone Number: 01041400; Email: kaisla.lahdensuo@mehilainen.fi
  • Tampere, Finland
    • Recruiting
    • Pirte
    • Contact: Teija Mertimo Phd, occupational health, Phd, occupational health; Phone Number: 0356564600; Email: teija.mertimo@pirte.fi
  • Tampere, Finland
    • Recruiting
    • Terveystalo
    • Contact: Riina-Riitta Helminen Phd, occupational health; Phone Number: 090030000; Email: riina-riitta.helminen@terveystalo.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Numeric pain rating scale	0 (no pain), 10 (worst imaginable pain)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total patient-experienced pain interference	0 (no interference), 10 (worst imaginable interference)	2 years
Claudication distance		2 years
Radiculative symptoms		2 years
Multiple pain in other areas	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	Amount of physiotherapy contacts before the study (during previous 3 months) and contacts between the survey points	2 years
Amount of mental health contacts	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	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)		2 years
GAD-7		2 years
BDI-2		2 years
EQ-5D-5L		2 years
ODI		2 years
Consumption of alcohol	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	Amount of nights with sleeping problems during the last week	2 years
Consumption of cigarettes	Consumption of cigarettes per day	2 years
Body weight		2 years
Physical acitivity	Times of physical acitivity (over 30 minutes) per week	2 years
Consumption of painkillers	Consumption of painkillers per week: paracetamol, NSAID, opioid	2 years
Consumption of antidepressants	Consumption of antidepressants per day	2 years
Consumption of benzodiazepines	Consumption of benzodiazepines per week (for sleep or/and anxiety)	2 years
Consumption of muscle relaxants	Consumption of muscle relaxants per week	2 years
Experienced benefit from the MBSR- course	0 (no benefit), 10 (the most imaginable benefit)	2 years
Complications of the intervention	Experienced complications of the intervention (open text)	2 years
Experienced total work ability now	0 (worst imaginable total work ability), 10 (best imaginable total work ability)	2 years
Experienced mental work ability now	0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)	2 years
Experienced physical work ability now	0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)	2 years
Experienced total work ability after 2 years	0 (worst imaginable total work ability), 10 (best imaginable total work ability)	2 years
Experienced mental work ability after 2 years	0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)	2 years
Experienced physical work ability after 2 years	0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)	2 years
Previous psychological diagnoses	Previous diagnosis in depression, anxiety disorder or burn-out	2 years
Rate of participation in MBSR course meetings	Rate of participation in MBSR course meetings (only week 8), 0-9 (meetings)	2 years
Amount of daily mindfulness practice	Amount of (daily 20 minutes, private) mindfulness practice during and after the course (daily, weekly, monthly, less, none)	2 years
Other received rehabilitation	No, rehabilitation course, McKenzie therapy, TENS, manipulation or psychophysical physiotherapy for back pain	2 years
Amount of contacts to the doctor for back pain	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	all the time, most of the time, sometimes, seldom, never	2 years
Experienced happiness during the last week	all the time, most of the time, sometimes, seldom, never	2 years
Experienced state of feeling energetic during the last week	all the time, most of the time, sometimes, seldom, never	2 years
Experienced contentment during the last week	all the time, most of the time, sometimes, seldom, never	2 years

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Tampere University; Pirte; Mehiläinen Tampere; Terveystalo Tampere
• Investigators: Study Director: Jussi Repo, PhD, M.D. orthopedical surgeon, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID 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