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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01303588
First received: February 24, 2011
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Low Back Pain
Behavioral: Yoga
Behavioral: Qigong
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga and Qigong for Elderly Patients With Chronic Low Back Pain

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Functional rating Index (FRI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Rating Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • FFb-HR [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Pain medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Falls [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Tinetti Test [ Time Frame: 3, 6 months ] [ Designated as safety issue: Yes ]
  • SF 36 [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 176
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01303588

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

Additional Information:
No publications provided

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
Study First Received: February 24, 2011
Last Updated: January 18, 2013
Health Authority: Germany: Charité University Berlin

Keywords provided by Charite University, Berlin, Germany:
elderly patients

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

ClinicalTrials.gov processed this record on November 25, 2014