NCT00758017CompletedNot Applicable
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
Charite University, Berlin, Germany2 sites in 1 country150 target enrollmentStarted: January 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Pain intensity over 8 weeks (area under the curve)
Study Overview
Brief Summary
The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant
- •indication for treatment of low back pain with acupuncture confirmed by a consultant
- •at least 40 mm on a VAS pain scale
Exclusion Criteria
- •acupuncture during the last 6 months
- •start of a new therapy for low back pain within the last 4 weeks
- •pregnancy
- •substance or drug abuse
Outcomes
Primary Outcomes
Pain intensity over 8 weeks (area under the curve)
Time Frame: 8 weeks
Secondary Outcomes
- Sick leave days(baseline, at week 8, at week 26)
- Number of therapy sessions(baseline to expected time frame 3 months)
- Intensity of back pain at week 8 and week 26(baseline, week 8, week 26)
- Back function (FFbH-R)(baseline, week 8, week 26)
- QoL(baseline, week 8, week 26)
- Days with medication intake(baseline to end of week 8)
- Days with physical therapy because of back pain(baseline to end of week 8)
- Duration of therapy(baseline to expected time frame 3 months)
- Adverse effects and severe adverse effects(baseline to expected time frame 3 months)
Investigators
Study Sites (2)
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