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Yoga and Qigong for Elderly Patients With Chronic Low Back Pain (YQ-LBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303588
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE February 24, 2011
First Posted Date  ICMJE February 25, 2011
Last Update Posted Date January 21, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
Functional rating Index (FRI) [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01303588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
  • Functional Rating Index [ Time Frame: 6 months ]
  • Visual Analogue Scale [ Time Frame: 3, 6 months ]
  • FFb-HR [ Time Frame: 3, 6 months ]
  • Pain medication [ Time Frame: 6 months ]
  • Falls [ Time Frame: 6 months ]
  • Tinetti Test [ Time Frame: 3, 6 months ]
  • SF 36 [ Time Frame: 3, 6 months ]
  • Geriatric Depression Scale [ Time Frame: 3, 6 months ]
  • Adverse events [ Time Frame: 6 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 Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
Official Title  ICMJE Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
Brief Summary The objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Behavioral: Yoga
    24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months
  • Behavioral: Qigong
    12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months
Study Arms  ICMJE
  • No Intervention: Waiting Group
  • Active Comparator: Qigong
    Intervention: Behavioral: Qigong
  • Active Comparator: Yoga
    Intervention: Behavioral: Yoga
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: January 18, 2013)
176
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2011)
180
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women ≥ 65 years of age
  • Chronic low back pain since 6 months at least
  • Functional Rating Index (FRI) ≥ 2 last 7 days
  • Informed consent form signed

Exclusion Criteria:

  • Disc prolapse with acute neurological symptoms
  • Previous spinal operations
  • Severe organic or psychiatric disease conditions, not allowing to participate in the trial
  • Use of opioids
  • Drug- and alcohol-addiction
  • Participation in another clinical trial within the last 6 months
  • Participation in yoga or qigong training within the last 12 months
  • Planned physical therapy within study duration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older 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 NCT01303588
Other Study ID Numbers  ICMJE YQ-LBP
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 Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date January 2013

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