Low Back Pain Clinical Trial
— YQ-LBPOfficial title:
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
| 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 |
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.
| 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany |
Germany,
| 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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