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
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 April 16, 2014