Qigong and Exercise for Neck Pain in Adults (QENA) (QENA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615732
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany

Brief Summary:
The purpose of this study is to assess the effectiveness of qigong for the treatment of chronic neck pain compared to exercise therapy and waiting list group.

Condition or disease Intervention/treatment Phase
Chronic Neck Pain Procedure: Qigong Procedure: exercise therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain
Study Start Date : March 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Procedure: Qigong
18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
Active Comparator: 2
exercise therapy
Procedure: exercise therapy
18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
No Intervention: 3

Primary Outcome Measures :
  1. average pain intensity during the last 7 days measured on a visual analogue scale (VAS) [ Time Frame: baseline, 3, 6, 12, and 24 months ]

Secondary Outcome Measures :
  1. Neck Pain and Disability Scale (NPAD, Wheeler 1999) [ Time Frame: baseline, 3, 6, 12, and 24 months ]
  2. health related quality of life (SF-36) [ Time Frame: baseline, 3, 6, 12 and 24 months ]
  3. patient expectation and self efficacy (questionnaire) [ Time Frame: Baseline, 3, 6, 12, and 24 months ]
  4. therapist's expectation [ Time Frame: baseline, 3, 6, 12, and 24 months ]
  5. undesired effects [ Time Frame: 3, 6, 12, and 24 months ]
  6. semi-structured interviews to detect changes due to therapy and to assess the used questionnaires [ Time Frame: 3 and 6 months ]

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical diagnosis of chronic neck pain since at least 6 months and complaints for a maximum duration of 5 years
  • neck 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)
  • normal mobility of the cervical spine
  • intellectual and physical ability to participate in the study
  • informed consent

Exclusion Criteria:

  • cervical pain related to malignancy
  • cervical 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 neck pain - such as swimming, yoga, pilates, tai chi, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615732

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Claudia M Witt, MD Charite University, Berlin, Germany

Publications of Results:
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany Identifier: NCT00615732     History of Changes
Other Study ID Numbers: QENA-08
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
traditional chinese medicine
exercise therapy
neck pain

Additional relevant MeSH terms:
Neck Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms