* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
8-week mindfulness course lead by psychologist, psychotherapist
Mehilainen
Tampere, Finland
RECRUITINGPirte
Tampere, Finland
RECRUITINGTampere University hospital
Tampere, Finland
RECRUITINGTerveystalo
Tampere, Finland
RECRUITINGNumeric pain rating scale
0 (no pain), 10 (worst imaginable pain)
Time frame: 2 years
Total patient-experienced pain interference
0 (no interference), 10 (worst imaginable interference)
Time frame: 2 years
Claudication distance
Time frame: 2 years
Radiculative symptoms
Time frame: 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)
Time frame: 2 years
Amount of physiotherapy contacts
Amount of physiotherapy contacts before the study (during previous 3 months) and contacts between the survey points
Time frame: 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
Time frame: 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
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
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).
Time frame: 2 years
Sleeping problems
Amount of nights with sleeping problems during the last week
Time frame: 2 years
Consumption of cigarettes
Consumption of cigarettes per day
Time frame: 2 years
Body weight
Time frame: 2 years
Physical acitivity
Times of physical acitivity (over 30 minutes) per week
Time frame: 2 years
Consumption of painkillers
Consumption of painkillers per week: paracetamol, NSAID, opioid
Time frame: 2 years
Consumption of antidepressants
Consumption of antidepressants per day
Time frame: 2 years
Consumption of benzodiazepines
Consumption of benzodiazepines per week (for sleep or/and anxiety)
Time frame: 2 years
Consumption of muscle relaxants
Consumption of muscle relaxants per week
Time frame: 2 years
Experienced benefit from the MBSR- course
0 (no benefit), 10 (the most imaginable benefit)
Time frame: 2 years
Complications of the intervention
Experienced complications of the intervention (open text)
Time frame: 2 years
Experienced total work ability now
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
Time frame: 2 years
Experienced mental work ability now
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
Time frame: 2 years
Experienced physical work ability now
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
Time frame: 2 years
Experienced total work ability after 2 years
0 (worst imaginable total work ability), 10 (best imaginable total work ability)
Time frame: 2 years
Experienced mental work ability after 2 years
0 (worst imaginable mental work ability), 10 (best imaginable mental work ability)
Time frame: 2 years
Experienced physical work ability after 2 years
0 (worst imaginable physical work ability), 10 (best imaginable physical work ability)
Time frame: 2 years
Previous psychological diagnoses
Previous diagnosis in depression, anxiety disorder or burn-out
Time frame: 2 years
Rate of participation in MBSR course meetings
Rate of participation in MBSR course meetings (only week 8), 0-9 (meetings)
Time frame: 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)
Time frame: 2 years
Other received rehabilitation
No, rehabilitation course, McKenzie therapy, TENS, manipulation or psychophysical physiotherapy for back pain
Time frame: 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
Time frame: 2 years
Experienced calmness during the last week
all the time, most of the time, sometimes, seldom, never
Time frame: 2 years
Experienced happiness during the last week
all the time, most of the time, sometimes, seldom, never
Time frame: 2 years
Experienced state of feeling energetic during the last week
all the time, most of the time, sometimes, seldom, never
Time frame: 2 years
Experienced contentment during the last week
all the time, most of the time, sometimes, seldom, never
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.