Qigong and Exercise Therapy for Low Back Pain in Adults

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of qigong for the treatment of low back pain compared to a stabilizing exercise therapy.

Official Title
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Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: qigong
* Procedure: exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of chronic low back pain since at least 3 months and complaints for a maximum duration of 5 years low back pain more prominent than other pain in the spine average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm) intellectual and physical ability to participate in the study informed consent Exclusion Criteria: low back pain related to malignancy low back pain due to an accident inflammatory joint disorders previous spine surgery protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology actually doing or planning to do other regular physical exercise during the study with possible positive effects on low back pain - such as swimming, yoga, pilates, tai chi, etc. planning to do another therapy during the study with possible positive effects in low back pain, such as physiotherapy, acupuncture, massage, spinal manipulation etc. use of pain drugs for other diseases (> 1x/week) pregnancy severe chronic or acute disease interfering with therapy attendance alcohol or substance abuse participation in another clinical trial in the last 6 months before study entry

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>qigong | Procedure: qigong<br>* one therapy session once a week during three months, that is 12 therapy sessions altogether<br>|
| Active Comparator: 2<br>exercise therapy | Procedure: exercise therapy<br>* one therapy session once a week during three months, that is 12 therapy sessions altogether<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average pain intensity during the last 7 days measured on a visual analogue scale (VAS) |  | baseline, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disability (Roland-Morris-Questionnaire RMQ) |  | baseline, 3, 6 and 12 months | 
| health related quality of life (SF 36) |  | baseline, 3, 6 and 12 months | 
| credibility of the therapy for patients |  | baseline, 3, 6 and 12 months | 
| patient expectation and self efficacy |  | baseline, 3, 6 and 12 months | 
| therapist's expectation |  | baseline, 3, 6 and 12 months | 
| sleep quality |  | baseline, 3, 6 and 12 months | 
| undesired effects |  | baseline, 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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qigong, traditional chinese medicine, exercise therapy, low back pain