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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
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE October 13, 2009
First Posted Date  ICMJE October 14, 2009
Last Update Posted Date July 10, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
average pain intensity during the last 7 days measured on a visual analogue scale (VAS) [ Time Frame: baseline, 3, 6 and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
  • disability (Roland-Morris-Questionnaire RMQ) [ Time Frame: baseline, 3, 6 and 12 months ]
  • health related quality of life (SF 36) [ Time Frame: baseline, 3, 6 and 12 months ]
  • credibility of the therapy for patients [ Time Frame: baseline, 3, 6 and 12 months ]
  • patient expectation and self efficacy [ Time Frame: baseline, 3, 6 and 12 months ]
  • therapist's expectation [ Time Frame: baseline, 3, 6 and 12 months ]
  • sleep quality [ Time Frame: baseline, 3, 6 and 12 months ]
  • undesired effects [ Time Frame: baseline, 3, 6 and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Qigong and Exercise Therapy for Low Back Pain in Adults
Official Title  ICMJE Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Procedure: qigong
    one therapy session once a week during three months, that is 12 therapy sessions altogether
  • Procedure: exercise therapy
    one therapy session once a week during three months, that is 12 therapy sessions altogether
Study Arms  ICMJE
  • Experimental: 1
    qigong
    Intervention: Procedure: qigong
  • Active Comparator: 2
    exercise therapy
    Intervention: Procedure: exercise therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2012)
127
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2009)
120
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00993980
Other Study ID Numbers  ICMJE QEBA-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claudia M. Witt, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claudia M Witt, MD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP