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

January 18, 2013 updated by: Claudia M. Witt, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional rating Index (FRI)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 6 months
6 months
Functional Rating Index
Time Frame: 6 months
6 months
Visual Analogue Scale
Time Frame: 3, 6 months
3, 6 months
FFb-HR
Time Frame: 3, 6 months
3, 6 months
Pain medication
Time Frame: 6 months
6 months
Falls
Time Frame: 6 months
6 months
Tinetti Test
Time Frame: 3, 6 months
3, 6 months
SF 36
Time Frame: 3, 6 months
3, 6 months
Geriatric Depression Scale
Time Frame: 3, 6 months
3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YQ-LBP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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