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Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00758017
First received: September 22, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
 Other: Acupuncture 1
Other: Acupuncture 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Pain intensity over 8 weeks (area under the curve) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity of back pain at week 8 and week 26 [ Time Frame: baseline, week 8, week 26 ] [ Designated as safety issue: No ]
  • Back function (FFbH-R) [ Time Frame: baseline, week 8, week 26 ] [ Designated as safety issue: No ]
  • QoL [ Time Frame: baseline, week 8, week 26 ] [ Designated as safety issue: No ]
  • Days with medication intake [ Time Frame: baseline to end of week 8 ] [ Designated as safety issue: No ]
  • Days with physical therapy because of back pain [ Time Frame: baseline to end of week 8 ] [ Designated as safety issue: No ]
  • Sick leave days [ Time Frame: baseline, at week 8, at week 26 ] [ Designated as safety issue: No ]
  • Number of therapy sessions [ Time Frame: baseline to expected time frame 3 months ] [ Designated as safety issue: No ]
  • Duration of therapy [ Time Frame: baseline to expected time frame 3 months ] [ Designated as safety issue: No ]
  • Adverse effects and severe adverse effects [ Time Frame: baseline to expected time frame 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture 1 Other: Acupuncture 1
Application of individualised acupuncture
Active Comparator: Acupuncture 2 Other: Acupuncture 2
Application of standardised acupuncture

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758017

Locations
Germany
ambulatory practice Yang-Strobel
Berlin, Germany, 13581
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia M. Witt, MD Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia M. Witt, MD, Institute for Social Medicine, Epidemiology, and Health Economics, Charité
ClinicalTrials.gov Identifier: NCT00758017     History of Changes
Other Study ID Numbers: Aku-08
Study First Received: September 22, 2008
Last Updated: June 21, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
low back pain
acupuncture

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013