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

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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

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Yoga Behavioral: Qigong Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Waiting Group
Active Comparator: Qigong Behavioral: Qigong
12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months
Active Comparator: Yoga Behavioral: Yoga
24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months



Primary Outcome Measures :
  1. Functional rating Index (FRI) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Functional Rating Index [ Time Frame: 6 months ]
  2. Visual Analogue Scale [ Time Frame: 3, 6 months ]
  3. FFb-HR [ Time Frame: 3, 6 months ]
  4. Pain medication [ Time Frame: 6 months ]
  5. Falls [ Time Frame: 6 months ]
  6. Tinetti Test [ Time Frame: 3, 6 months ]
  7. SF 36 [ Time Frame: 3, 6 months ]
  8. Geriatric Depression Scale [ Time Frame: 3, 6 months ]
  9. Adverse events [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01303588


Locations
Germany
Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany

Responsible Party: Claudia M. Witt, Prof. Dr. med, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01303588     History of Changes
Other Study ID Numbers: YQ-LBP
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
elderly patients

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