Qigong and Exercise Therapy for Low Back Pain in Adults (QEBA)

July 9, 2012 updated by: Claudia M. Witt, Charite University, Berlin, Germany

Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain

The purpose of this study is to assess the effectiveness of qigong for the treatment of low back pain compared to a stabilizing exercise therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

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, 10117
        • Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of chronic low back pain since at least 3 months and complaints for a maximum duration of 5 years
  • low back pain more prominent than other pain in the spine
  • average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
  • intellectual and physical ability to participate in the study
  • informed consent

Exclusion Criteria:

  • low back pain related to malignancy
  • low back pain due to an accident
  • inflammatory joint disorders
  • previous spine surgery
  • protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
  • actually doing or planning to do other regular physical exercise during the study with possible positive effects on low back pain - such as swimming, yoga, pilates, tai chi, etc.
  • planning to do another therapy during the study with possible positive effects in low back pain, such as physiotherapy, acupuncture, massage, spinal manipulation etc.
  • use of pain drugs for other diseases (> 1x/week)
  • pregnancy
  • severe chronic or acute disease interfering with therapy attendance
  • alcohol or substance abuse
  • participation in another clinical trial in the last 6 months before study entry

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
qigong
Procedure: qigong
one therapy session once a week during three months, that is 12 therapy sessions altogether
Active Comparator: 2
exercise therapy
Procedure: exercise therapy
one therapy session once a week during three months, that is 12 therapy sessions altogether

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
disability (Roland-Morris-Questionnaire RMQ)
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months
health related quality of life (SF 36)
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months
credibility of the therapy for patients
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months
patient expectation and self efficacy
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months
therapist's expectation
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months
sleep quality
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months
undesired effects
Time Frame: baseline, 3, 6 and 12 months
baseline, 3, 6 and 12 months

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Claudia M Witt, MD, Charite University, Berlin, Germany

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

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QEBA-09

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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