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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Yoga
Qigong
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring elderly patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Waiting Group

Qigong

Yoga

Arm Description

Outcomes

Primary Outcome Measures

Functional rating Index (FRI)

Secondary Outcome Measures

Functional Rating Index
Visual Analogue Scale
FFb-HR
Pain medication
Falls
Tinetti Test
SF 36
Geriatric Depression Scale
Adverse events

Full Information

First Posted
February 24, 2011
Last Updated
January 18, 2013
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01303588
Brief Title
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
Acronym
YQ-LBP
Official Title
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
elderly patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waiting Group
Arm Type
No Intervention
Arm Title
Qigong
Arm Type
Active Comparator
Arm Title
Yoga
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months
Intervention Type
Behavioral
Intervention Name(s)
Qigong
Intervention Description
12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months
Primary Outcome Measure Information:
Title
Functional rating Index (FRI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Functional Rating Index
Time Frame
6 months
Title
Visual Analogue Scale
Time Frame
3, 6 months
Title
FFb-HR
Time Frame
3, 6 months
Title
Pain medication
Time Frame
6 months
Title
Falls
Time Frame
6 months
Title
Tinetti Test
Time Frame
3, 6 months
Title
SF 36
Time Frame
3, 6 months
Title
Geriatric Depression Scale
Time Frame
3, 6 months
Title
Adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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