Back PainNCT07528833
Health Effects of Mindfulness Based Stress Reduction Course in Treatment of Back Pain
A study testing Mindfulness based stress reduction (MBSR) course in people with Back Pain, run by Tampere University Hospital at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Mindfulness based stress reduction (MBSR) course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFinland
- Study dates
- 1 Jan 2025to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 9Show fewer
- surgery (< 6 months)
- planned surgery in the future
- tumor in the back
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites, 4 recruiting
- Recruiting
Mehilainen
Tampere
Kaisla Lahdensuo Phd, psychiatrician, Phd, psychiatrician, 01041400, kaisla.lahdensuo@mehilainen.fi
- Recruiting
Pirte
Tampere
Teija Mertimo Phd, occupational health, Phd, occupational health, 0356564600, teija.mertimo@pirte.fi
- Recruiting
Tampere University hospital
Tampere
Jussi Repo Study director, Phd, MD, orthopedical surgeon, 090030000, jussi.repo@pirha.fi
Jenna Sisouno Researcher, MD, pediatric surgeon, 01041400, jennasisouno@gmail.com
- Recruiting
Terveystalo
Tampere
Riina-Riitta Helminen Phd, occupational health, 090030000, riina-riitta.helminen@terveystalo.com
About this study
Official title: 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).
- Conditions
- Back Pain
- Being tested
- Mindfulness based stress reduction (MBSR) course
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based stress reduction (MBSR) courseBehavioural
8-week mindfulness course lead by psychologist, psychotherapist
| Study group | Role | What they receive |
|---|---|---|
| MBSR intervention | Experimental | Not described Receives: Behavioral: Mindfulness based stress reduction (MBSR) course |
| Control group with usual care for back pain | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
0 (no pain), 10 (worst imaginable pain)
Measured: 2 years
Secondary outcomes (38)
Total patient-experienced pain interference
0 (no interference), 10 (worst imaginable interference)
Measured: 2 years
Claudication distance
Measured: 2 years
Radiculative symptoms
Measured: 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)
Measured: 2 years
Amount of physiotherapy contacts
Amount of physiotherapy contacts before the study (during previous 3 months) and contacts between the survey points
Measured: 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
Measured: 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
Measured: 2 years
Burnout assessement tool (BAT-12)
Measured: 2 years
GAD-7
Measured: 2 years
BDI-2
Measured: 2 years
EQ-5D-5L
Measured: 2 years
ODI
Measured: 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).
Measured: 2 years
Sleeping problems
Amount of nights with sleeping problems during the last week
Measured: 2 years
Consumption of cigarettes
Consumption of cigarettes per day
Measured: 2 years
Body weight
Measured: 2 years
Physical acitivity
Times of physical acitivity (over 30 minutes) per week
Measured: 2 years
Consumption of painkillers
Consumption of painkillers per week: paracetamol, NSAID, opioid
Measured: 2 years
Consumption of antidepressants
Consumption of antidepressants per day
Measured: 2 years
Consumption of benzodiazepines
Consumption of benzodiazepines per week (for sleep or/and anxiety)
Measured: 2 years
Consumption of muscle relaxants
Consumption of muscle relaxants per week
Measured: 2 years
Experienced benefit from the MBSR- course
0 (no benefit), 10 (the most imaginable benefit)
Measured: 2 years
Complications of the intervention
Experienced complications of the intervention (open text)
Measured: 2 years
Experienced total work ability now
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
Measured: 2 years
Experienced mental work ability now
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
Measured: 2 years
Experienced physical work ability now
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
Measured: 2 years
Experienced total work ability after 2 years
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
Measured: 2 years
Experienced mental work ability after 2 years
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
Measured: 2 years
Experienced physical work ability after 2 years
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
Measured: 2 years
Previous psychological diagnoses
Previous diagnosis in depression, anxiety disorder or burn-out
Measured: 2 years
Rate of participation in MBSR course meetings
Rate of participation in MBSR course meetings (only week 8), 0-9 (meetings)
Measured: 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)
Measured: 2 years
Other received rehabilitation
No, rehabilitation course, McKenzie therapy, TENS, manipulation or psychophysical physiotherapy for back pain
Measured: 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
Measured: 2 years
Experienced calmness during the last week
all the time, most of the time, sometimes, seldom, never
Measured: 2 years
Experienced happiness during the last week
all the time, most of the time, sometimes, seldom, never
Measured: 2 years
Experienced state of feeling energetic during the last week
all the time, most of the time, sometimes, seldom, never
Measured: 2 years
Experienced contentment during the last week
all the time, most of the time, sometimes, seldom, never
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MBSR versus control group with usual care for back pain
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pirte, Mehiläinen Tampere, Terveystalo Tampere, Tampere University
- Responsible party
- Sponsor
- Investigators
- Jussi Repo, PhD, M.D. orthopedical surgeon, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528833
- Sponsor's protocol ID
- R23051
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Mindfulness Based Stress Reduction Course Versus Usual Care in Treatment of Back Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07528833
- Acronym / sponsor ID
- R23051
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Pirte, Mehiläinen Tampere, Terveystalo Tampere, Tampere University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- MBSR versus control group with usual care for back pain
| Arm | Type | Receives |
|---|---|---|
| MBSR intervention | Experimental | Behavioral: Mindfulness based stress reduction (MBSR) course |
| Control group with usual care for back pain | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Recent delivery (<12 months)
- Mental health problems with psychotic symptoms
- Acute severe psychological trauma (3 months)
- Sings of back infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based stress reduction (MBSR) course8-week mindfulness course lead by psychologist, psychotherapist | Behavioural | MBSR intervention |
Primary outcome
Numeric pain rating scale
Time frame: 2 years
0 (no pain), 10 (worst imaginable pain)
38 secondary outcomes
Total patient-experienced pain interference
Time frame: 2 years
Claudication distance
Time frame: 2 years
Radiculative symptoms
Time frame: 2 years
Multiple pain in other areas
Time frame: 2 years
Amount of physiotherapy contacts
Time frame: 2 years
Amount of mental health contacts
Time frame: 2 years
Amount of sick leave
Time frame: 2 years
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
Sleeping problems
Time frame: 2 years
Consumption of cigarettes
Time frame: 2 years
Body weight
Time frame: 2 years
Physical acitivity
Time frame: 2 years
Consumption of painkillers
Time frame: 2 years
Consumption of antidepressants
Time frame: 2 years
Consumption of benzodiazepines
Time frame: 2 years
Consumption of muscle relaxants
Time frame: 2 years
Experienced benefit from the MBSR- course
Time frame: 2 years
Complications of the intervention
Time frame: 2 years
Experienced total work ability now
Time frame: 2 years
Experienced mental work ability now
Time frame: 2 years
Experienced physical work ability now
Time frame: 2 years
Experienced total work ability after 2 years
Time frame: 2 years
Experienced mental work ability after 2 years
Time frame: 2 years
Experienced physical work ability after 2 years
Time frame: 2 years
Previous psychological diagnoses
Time frame: 2 years
Rate of participation in MBSR course meetings
Time frame: 2 years
Amount of daily mindfulness practice
Time frame: 2 years
Other received rehabilitation
Time frame: 2 years
Amount of contacts to the doctor for back pain
Time frame: 2 years
Experienced calmness during the last week
Time frame: 2 years
Experienced happiness during the last week
Time frame: 2 years
Experienced state of feeling energetic during the last week
Time frame: 2 years
Experienced contentment during the last week
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jussi Repo, PhD, M.D. orthopedical surgeon study director
Tampere University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based stress reduction (MBSR) course in people with Back Pain, run by Tampere University Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna Sisouno Researcher, M.D., Pediatric surgeon (01041400, jennasisouno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.