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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014