Mindfulness based stress reduction (MBSR) course
Behavioral8-week mindfulness course lead by psychologist, psychotherapist
Recruiting
NCT Number: NCT07528833
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 * 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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Mehilainen, Tampere, Finland
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Numeric pain rating scale
Time frame: 2 years
0 (no pain), 10 (worst imaginable pain)
Secondary outcomes
-
Total patient-experienced pain interference
Time frame: 2 years
0 (no interference), 10 (worst imaginable interference)
-
Claudication distance
Time frame: 2 years
-
Radiculative symptoms
Time frame: 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)
-
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
-
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
-
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
-
Burnout assessement tool (BAT-12)
Time frame: 2 years
-
GAD-7
Time frame: 2 years
-
BDI-2
Time frame: 2 years
-
EQ-5D-5L
Time frame: 2 years
-
ODI
Time frame: 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).
-
Sleeping problems
Time frame: 2 years
Amount of nights with sleeping problems during the last week
-
Consumption of cigarettes
Time frame: 2 years
Consumption of cigarettes per day
-
Body weight
Time frame: 2 years
-
Physical acitivity
Time frame: 2 years
Times of physical acitivity (over 30 minutes) per week
-
Consumption of painkillers
Time frame: 2 years
Consumption of painkillers per week: paracetamol, NSAID, opioid
-
Consumption of antidepressants
Time frame: 2 years
Consumption of antidepressants per day
-
Consumption of benzodiazepines
Time frame: 2 years
Consumption of benzodiazepines per week (for sleep or/and anxiety)
-
Consumption of muscle relaxants
Time frame: 2 years
Consumption of muscle relaxants per week
-
Experienced benefit from the MBSR- course
Time frame: 2 years
0 (no benefit), 10 (the most imaginable benefit)
-
Complications of the intervention
Time frame: 2 years
Experienced complications of the intervention (open text)
-
Experienced total work ability now
Time frame: 2 years
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
-
Experienced mental work ability now
Time frame: 2 years
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
-
Experienced physical work ability now
Time frame: 2 years
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
-
Experienced total work ability after 2 years
Time frame: 2 years
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
-
Experienced mental work ability after 2 years
Time frame: 2 years
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
-
Experienced physical work ability after 2 years
Time frame: 2 years
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
-
Previous psychological diagnoses
Time frame: 2 years
Previous diagnosis in depression, anxiety disorder or burn-out
-
Rate of participation in MBSR course meetings
Time frame: 2 years
Rate of participation in MBSR course meetings (only week 8), 0-9 (meetings)
-
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)
-
Other received rehabilitation
Time frame: 2 years
No, rehabilitation course, McKenzie therapy, TENS, manipulation or psychophysical physiotherapy for back pain
-
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
-
Experienced calmness during the last week
Time frame: 2 years
all the time, most of the time, sometimes, seldom, never
-
Experienced happiness during the last week
Time frame: 2 years
all the time, most of the time, sometimes, seldom, never
-
Experienced state of feeling energetic during the last week
Time frame: 2 years
all the time, most of the time, sometimes, seldom, never
-
Experienced contentment during the last week
Time frame: 2 years
all the time, most of the time, sometimes, seldom, never
Study contacts
Contact information is provided by the study sponsor or research team.
Jenna Sisouno Researcher, M.D., Pediatric surgeon
CONTACT
Jussi Repo Study director, PhD, M.D. orthopedical surgeon
CONTACT
Sponsors and collaborators
Lead sponsor
Tampere University Hospital
Other
Collaborators
- Mehiläinen Tampere
- Pirte
- Tampere University
- Terveystalo Tampere
Registry information
Official study title
Health Effects of Mindfulness Based Stress Reduction Course Versus Usual Care in Treatment of Back Pain: a Randomized Clinical Trial
Important dates
- Study start
- 2025
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Apr 14, 2026
- Registry last updated
- Apr 14, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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