Health TrialsbyHealthPanel

Health Effects of Mindfulness Based Stress Reduction Course in Treatment of Back Pain

ConditionBack Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorTampere University Hospital

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Working-age (18-64 years) patients

Back pain in thoracal or lumbar area

NRS at least 4

With or without radiculative symptoms

Disqualifiers

Pregnancy

Recent delivery (<12 months)

Mental health problems with psychotic symptoms

Acute severe psychological trauma (3 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness based stress reduction (MBSR) course

    Behavioral

    8-week mindfulness course lead by psychologist, psychotherapist

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: MBSR interventionExperimental treatment 1 intervention
Group B: Control group with usual care for back painNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Numeric pain rating scale

0 (no pain), 10 (worst imaginable pain)

Time frame
2 years

Secondary outcomes

1

Total patient-experienced pain interference

0 (no interference), 10 (worst imaginable interference)

Time frame
2 years
2

Claudication distance

Time frame
2 years
3

Radiculative symptoms

Time frame
2 years
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University Hospital

Lead sponsor

Pirte

Collaborator

Mehiläinen Tampere

Collaborator

Terveystalo Tampere

Collaborator

Tampere University

Collaborator

Source ClinicalTrials.gov
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