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Clinical Trials/NCT00758017
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

Sponsor Class
Other

Study Sites (2)

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