Qigong and Exercise Therapy for Low Back Pain in Adults

Low Back Pain Clinical Trial

— QEBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993980
• Other study ID #: QEBA-09
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: July 9, 2012
• Start date: October 2009
• Est. completion date: January 2011

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• qigong
one therapy session once a week during three months, that is 12 therapy sessions altogether
• exercise therapy
one therapy session once a week during three months, that is 12 therapy sessions altogether

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average pain intensity during the last 7 days measured on a visual analogue scale (VAS)		baseline, 3, 6 and 12 months	No
Secondary	disability (Roland-Morris-Questionnaire RMQ)		baseline, 3, 6 and 12 months	No
Secondary	health related quality of life (SF 36)		baseline, 3, 6 and 12 months	No
Secondary	credibility of the therapy for patients		baseline, 3, 6 and 12 months	No
Secondary	patient expectation and self efficacy		baseline, 3, 6 and 12 months	No
Secondary	therapist's expectation		baseline, 3, 6 and 12 months	No
Secondary	sleep quality		baseline, 3, 6 and 12 months	No
Secondary	undesired effects		baseline, 3, 6 and 12 months	Yes