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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00993980
First received: October 13, 2009
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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 Intervention
Low Back Pain
Procedure: qigong
Procedure: exercise therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • average pain intensity during the last 7 days measured on a visual analogue scale (VAS) [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disability (Roland-Morris-Questionnaire RMQ) [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • health related quality of life (SF 36) [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • credibility of the therapy for patients [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • patient expectation and self efficacy [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • therapist's expectation [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • sleep quality [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • undesired effects [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 127
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
qigong
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993980

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

No publications provided

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
Study First Received: October 13, 2009
Last Updated: July 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
qigong
traditional chinese medicine
exercise therapy
low back pain

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

ClinicalTrials.gov processed this record on September 18, 2014