Qigong and Exercise Therapy for Low Back Pain in Adults

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: qigong; Procedure: exercise therapy

• Registration Number: NCT00993980
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2010-03
• Study Completion: 2011-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	qigong	qigong
2	exercise therapy	exercise therapy

Primary Outcome Measures

Name	Time	Method
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)	baseline, 3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center; 🇩🇪 Berlin, Germany