Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

June 21, 2011 updated by: Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13581
        • ambulatory practice Yang-Strobel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity over 8 weeks (area under the curve)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensity of back pain at week 8 and week 26
Time Frame: baseline, week 8, week 26
baseline, week 8, week 26
Back function (FFbH-R)
Time Frame: baseline, week 8, week 26
baseline, week 8, week 26
QoL
Time Frame: baseline, week 8, week 26
baseline, week 8, week 26
Days with medication intake
Time Frame: baseline to end of week 8
baseline to end of week 8
Days with physical therapy because of back pain
Time Frame: baseline to end of week 8
baseline to end of week 8
Sick leave days
Time Frame: baseline, at week 8, at week 26
baseline, at week 8, at week 26
Number of therapy sessions
Time Frame: baseline to expected time frame 3 months
baseline to expected time frame 3 months
Duration of therapy
Time Frame: baseline to expected time frame 3 months
baseline to expected time frame 3 months
Adverse effects and severe adverse effects
Time Frame: baseline to expected time frame 3 months
baseline to expected time frame 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aku-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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