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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
qigong
exercise therapy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring qigong, traditional chinese medicine, exercise therapy, low back pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

qigong

exercise therapy

Outcomes

Primary Outcome Measures

average pain intensity during the last 7 days measured on a visual analogue scale (VAS)

Secondary Outcome Measures

disability (Roland-Morris-Questionnaire RMQ)
health related quality of life (SF 36)
credibility of the therapy for patients
patient expectation and self efficacy
therapist's expectation
sleep quality
undesired effects

Full Information

First Posted
October 13, 2009
Last Updated
July 9, 2012
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00993980
Brief Title
Qigong and Exercise Therapy for Low Back Pain in Adults
Acronym
QEBA
Official Title
Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
qigong, traditional chinese medicine, exercise therapy, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
qigong
Arm Title
2
Arm Type
Active Comparator
Arm Description
exercise therapy
Intervention Type
Procedure
Intervention Name(s)
qigong
Intervention Description
one therapy session once a week during three months, that is 12 therapy sessions altogether
Intervention Type
Procedure
Intervention Name(s)
exercise therapy
Intervention Description
one therapy session once a week during three months, that is 12 therapy sessions altogether
Primary Outcome Measure Information:
Title
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)
Time Frame
baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
disability (Roland-Morris-Questionnaire RMQ)
Time Frame
baseline, 3, 6 and 12 months
Title
health related quality of life (SF 36)
Time Frame
baseline, 3, 6 and 12 months
Title
credibility of the therapy for patients
Time Frame
baseline, 3, 6 and 12 months
Title
patient expectation and self efficacy
Time Frame
baseline, 3, 6 and 12 months
Title
therapist's expectation
Time Frame
baseline, 3, 6 and 12 months
Title
sleep quality
Time Frame
baseline, 3, 6 and 12 months
Title
undesired effects
Time Frame
baseline, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Witt, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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Qigong and Exercise Therapy for Low Back Pain in Adults

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