Qigong and Exercise Therapy for Low Back Pain in Adults

NCT ID: NCT00993980

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Keywords

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qigong traditional chinese medicine exercise therapy low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

qigong

Group Type EXPERIMENTAL

qigong

Intervention Type PROCEDURE

one therapy session once a week during three months, that is 12 therapy sessions altogether

2

exercise therapy

Group Type ACTIVE_COMPARATOR

exercise therapy

Intervention Type PROCEDURE

one therapy session once a week during three months, that is 12 therapy sessions altogether

Interventions

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qigong

one therapy session once a week during three months, that is 12 therapy sessions altogether

Intervention Type PROCEDURE

exercise therapy

one therapy session once a week during three months, that is 12 therapy sessions altogether

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia M Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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QEBA-09

Identifier Type: -

Identifier Source: org_study_id