Back Pain
Conditions
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).
Interventions
BEHAVIORALMindfulness based stress reduction (MBSR) course
8-week mindfulness course lead by psychologist, psychotherapist
Sponsors
Tampere University Hospital
Pirte
Mehiläinen Tampere
Terveystalo Tampere
Tampere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
MBSR versus control group with usual care for back pain
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric pain rating scale | 2 years | 0 (no pain), 10 (worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total patient-experienced pain interference | 2 years | 0 (no interference), 10 (worst imaginable interference) |
| Claudication distance | 2 years | — |
| Radiculative symptoms | 2 years | — |
| Multiple pain in other areas | 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 | 2 years | Amount of physiotherapy contacts before the study (during previous 3 months) and contacts between the survey points |
| Amount of mental health contacts | 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 | 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) | 2 years | — |
| GAD-7 | 2 years | — |
| BDI-2 | 2 years | — |
| EQ-5D-5L | 2 years | — |
| ODI | 2 years | — |
| Consumption of alcohol | 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 | 2 years | Amount of nights with sleeping problems during the last week |
| Consumption of cigarettes | 2 years | Consumption of cigarettes per day |
| Body weight | 2 years | — |
| Physical acitivity | 2 years | Times of physical acitivity (over 30 minutes) per week |
| Consumption of painkillers | 2 years | Consumption of painkillers per week: paracetamol, NSAID, opioid |
| Consumption of antidepressants | 2 years | Consumption of antidepressants per day |
| Consumption of benzodiazepines | 2 years | Consumption of benzodiazepines per week (for sleep or/and anxiety) |
| Consumption of muscle relaxants | 2 years | Consumption of muscle relaxants per week |
| Experienced benefit from the MBSR- course | 2 years | 0 (no benefit), 10 (the most imaginable benefit) |
| Complications of the intervention | 2 years | Experienced complications of the intervention (open text) |
| Experienced total work ability now | 2 years | 0 (worst imaginable total work ability), 10 (best imaginable total work ability) |
| Experienced mental work ability now | 2 years | 0 (worst imaginable mental work ability), 10 (best imaginable mental work ability) |
| Experienced physical work ability now | 2 years | 0 (worst imaginable physical work ability), 10 (best imaginable physical work ability) |
| Experienced total work ability after 2 years | 2 years | 0 (worst imaginable total work ability), 10 (best imaginable total work ability) |
| Experienced mental work ability after 2 years | 2 years | 0 (worst imaginable mental work ability), 10 (best imaginable mental work ability) |
| Experienced physical work ability after 2 years | 2 years | 0 (worst imaginable physical work ability), 10 (best imaginable physical work ability) |
| Previous psychological diagnoses | 2 years | Previous diagnosis in depression, anxiety disorder or burn-out |
| Rate of participation in MBSR course meetings | 2 years | Rate of participation in MBSR course meetings (only week 8), 0-9 (meetings) |
| Amount of daily mindfulness practice | 2 years | Amount of (daily 20 minutes, private) mindfulness practice during and after the course (daily, weekly, monthly, less, none) |
| Other received rehabilitation | 2 years | No, rehabilitation course, McKenzie therapy, TENS, manipulation or psychophysical physiotherapy for back pain |
| Amount of contacts to the doctor for back pain | 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 | 2 years | all the time, most of the time, sometimes, seldom, never |
| Experienced happiness during the last week | 2 years | all the time, most of the time, sometimes, seldom, never |
| Experienced state of feeling energetic during the last week | 2 years | all the time, most of the time, sometimes, seldom, never |
| Experienced contentment during the last week | 2 years | all the time, most of the time, sometimes, seldom, never |
Countries
Finland
Contacts
CONTACTJenna Sisouno Researcher, M.D., Pediatric surgeon
CONTACTJussi Repo Study director, PhD, M.D. orthopedical surgeon
STUDY_DIRECTORJussi Repo, PhD, M.D. orthopedical surgeon
Tampere University Hospital
Outcome results
None listed