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Qigong and Exercise Therapy for Low Back Pain in Adults (QEBA)

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ClinicalTrials.gov Identifier: NCT00993980
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Low Back Pain Procedure: qigong Procedure: exercise therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Procedure: qigong
one therapy session once a week during three months, that is 12 therapy sessions altogether
Active Comparator: 2
exercise therapy
Procedure: exercise therapy
one therapy session once a week during three months, that is 12 therapy sessions altogether

Outcome Measures

Primary Outcome Measures :
  1. average pain intensity during the last 7 days measured on a visual analogue scale (VAS) [ Time Frame: baseline, 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. disability (Roland-Morris-Questionnaire RMQ) [ Time Frame: baseline, 3, 6 and 12 months ]
  2. health related quality of life (SF 36) [ Time Frame: baseline, 3, 6 and 12 months ]
  3. credibility of the therapy for patients [ Time Frame: baseline, 3, 6 and 12 months ]
  4. patient expectation and self efficacy [ Time Frame: baseline, 3, 6 and 12 months ]
  5. therapist's expectation [ Time Frame: baseline, 3, 6 and 12 months ]
  6. sleep quality [ Time Frame: baseline, 3, 6 and 12 months ]
  7. undesired effects [ Time Frame: baseline, 3, 6 and 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993980

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Claudia M Witt, MD Charite University, Berlin, Germany
More Information

Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00993980     History of Changes
Other Study ID Numbers: QEBA-09
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
traditional chinese medicine
exercise therapy
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms