Health Effects of Mindfulness Based Stress Reduction Course in Treatment of Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness based stress reduction (MBSR) course.
- Who it may be relevant to
- Registry conditions: Back Pain. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Health Effects of Mindfulness Based Stress Reduction Course Versus Usual Care in Treatment of Back Pain: a Randomized Clinical Trial
Overview
* 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
- Behavioral Mindfulness based stress reduction (MBSR) course
8-week mindfulness course lead by psychologist, psychotherapist
Primary outcome measures
- Numeric pain rating scale [Time frame: 2 years]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 4 centers
- Mehilainen — Tampere
- Pirte — Tampere
- Tampere University hospital — Tampere
- Terveystalo — Tampere
Identifiers
NCT: NCT07528833 · R23051