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Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00758017
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Chronic Low Back Pain Other: Acupuncture 1 Other: Acupuncture 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
Study Start Date : January 2009
Primary Completion Date : March 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Acupuncture 1 Other: Acupuncture 1
Application of individualised acupuncture
Active Comparator: Acupuncture 2 Other: Acupuncture 2
Application of standardised acupuncture


Outcome Measures

Primary Outcome Measures :
  1. Pain intensity over 8 weeks (area under the curve) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Intensity of back pain at week 8 and week 26 [ Time Frame: baseline, week 8, week 26 ]
  2. Back function (FFbH-R) [ Time Frame: baseline, week 8, week 26 ]
  3. QoL [ Time Frame: baseline, week 8, week 26 ]
  4. Days with medication intake [ Time Frame: baseline to end of week 8 ]
  5. Days with physical therapy because of back pain [ Time Frame: baseline to end of week 8 ]
  6. Sick leave days [ Time Frame: baseline, at week 8, at week 26 ]
  7. Number of therapy sessions [ Time Frame: baseline to expected time frame 3 months ]
  8. Duration of therapy [ Time Frame: baseline to expected time frame 3 months ]
  9. Adverse effects and severe adverse effects [ Time Frame: baseline to expected time frame 3 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

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