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Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758017
First Posted: September 23, 2008
Last Update Posted: June 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
September 22, 2008
September 23, 2008
June 22, 2011
January 2009
March 2011   (Final data collection date for primary outcome measure)
Pain intensity over 8 weeks (area under the curve) [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT00758017 on ClinicalTrials.gov Archive Site
  • Intensity of back pain at week 8 and week 26 [ Time Frame: baseline, week 8, week 26 ]
  • Back function (FFbH-R) [ Time Frame: baseline, week 8, week 26 ]
  • QoL [ Time Frame: baseline, week 8, week 26 ]
  • Days with medication intake [ Time Frame: baseline to end of week 8 ]
  • Days with physical therapy because of back pain [ Time Frame: baseline to end of week 8 ]
  • Sick leave days [ Time Frame: baseline, at week 8, at week 26 ]
  • Number of therapy sessions [ Time Frame: baseline to expected time frame 3 months ]
  • Duration of therapy [ Time Frame: baseline to expected time frame 3 months ]
  • Adverse effects and severe adverse effects [ Time Frame: baseline to expected time frame 3 months ]
  • Intensity of back pain at week 8 and week 26 [ Time Frame: baseline, week 8, week 26 ]
  • Back function (FFbH-R) [ Time Frame: baseline, week 8, week 26 ]
  • QoL [ Time Frame: baseline, week 8, week 26 ]
  • Days with medication intake [ Time Frame: baseline to end of week 8 ]
  • Days with physical therapy because of back pain [ Time Frame: baseline to end of week 8 ]
  • Sick leave days [ Time Frame: baseline, at week 8, at week 26 ]
  • Number of therapy sessions [ Time Frame: baseline to end of therapy ]
  • Duration of therapy [ Time Frame: baseline to end of therapy ]
  • Adverse effects and severe adverse effects [ Time Frame: baseline to end of therapy ]
Not Provided
Not Provided
 
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Chronic Low Back Pain
  • Other: Acupuncture 1
    Application of individualised acupuncture
  • Other: Acupuncture 2
    Application of standardised acupuncture
  • Experimental: Acupuncture 1
    Intervention: Other: Acupuncture 1
  • Active Comparator: Acupuncture 2
    Intervention: Other: Acupuncture 2
Pach D, Yang-Strobel X, Lüdtke R, Roll S, Icke K, Brinkhaus B, Witt CM. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2013;2013:125937. doi: 10.1155/2013/125937. Epub 2013 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00758017
Aku-08
No
Not Provided
Not Provided
Claudia M. Witt, MD, Institute for Social Medicine, Epidemiology, and Health Economics, Charité
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Claudia M. Witt, MD Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
Charite University, Berlin, Germany
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP