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Completed

NCT Number: NCT00993980

Qigong and Exercise Therapy for Low Back Pain in Adults

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.

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Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qigong

Procedure

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

Exercise therapy

Procedure

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

Primary outcomes

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

    Time frame: baseline, 3, 6 and 12 months

Secondary outcomes

  1. disability (Roland-Morris-Questionnaire RMQ)

    Time frame: baseline, 3, 6 and 12 months

  2. health related quality of life (SF 36)

    Time frame: baseline, 3, 6 and 12 months

  3. credibility of the therapy for patients

    Time frame: baseline, 3, 6 and 12 months

  4. patient expectation and self efficacy

    Time frame: baseline, 3, 6 and 12 months

  5. therapist's expectation

    Time frame: baseline, 3, 6 and 12 months

  6. sleep quality

    Time frame: baseline, 3, 6 and 12 months

  7. undesired effects

    Time frame: baseline, 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: QEBA

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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