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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

September 22, 2008
June 21, 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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
  • 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 end of therapy ] [ Designated as safety issue: No ]
  • Duration of therapy [ Time Frame: baseline to end of therapy ] [ Designated as safety issue: No ]
  • Adverse effects and severe adverse effects [ Time Frame: baseline to end of therapy ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00758017
Aku-08
No
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