Qigong and Exercise Therapy for Low Back Pain in Adults

NCT00993980 | Completed

• 1 other identifier: QEBA-09
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

qigong; traditional chinese medicine; exercise therapy; low back pain

Outcome Measures

Primary Outcomes (1)

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

  baseline, 3, 6 and 12 months

Secondary Outcomes (7)

• disability (Roland-Morris-Questionnaire RMQ)

  baseline, 3, 6 and 12 months

• health related quality of life (SF 36)

  baseline, 3, 6 and 12 months

• credibility of the therapy for patients

  baseline, 3, 6 and 12 months

• patient expectation and self efficacy

  baseline, 3, 6 and 12 months

• therapist's expectation

  baseline, 3, 6 and 12 months

Study Arms (2)

1

EXPERIMENTAL

qigong

Procedure: qigong

2

ACTIVE COMPARATOR

exercise therapy

Procedure: exercise therapy

Interventions

qigong PROCEDURE

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

1

exercise therapy PROCEDURE

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

2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Qigong; Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Claudia M Witt, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

DE (1)