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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01303588
Other study ID # YQ-LBP
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received February 24, 2011
Last updated January 18, 2013
Start date May 2011
Est. completion date December 2012

Study information

Verified date January 2013
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Charité University Berlin
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date December 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga
24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months
Qigong
12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months

Locations

Country Name City State
Germany Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional rating Index (FRI) 3 months No
Secondary Functional Rating Index 6 months No
Secondary Visual Analogue Scale 3, 6 months No
Secondary FFb-HR 3, 6 months No
Secondary Pain medication 6 months No
Secondary Falls 6 months Yes
Secondary Tinetti Test 3, 6 months Yes
Secondary SF 36 3, 6 months No
Secondary Geriatric Depression Scale 3, 6 months No
Secondary Adverse events 6 months Yes
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