Qigong and Exercise for Neck Pain in Adults (QENA) - Full Text View

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00615732

Purpose

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	Intervention
Chronic Neck Pain	Procedure: Qigong Procedure: exercise therapy

MedlinePlus related topics: Exercise and Physical Fitness Neck Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain.

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

average pain intensity during the last 7 days measured on a visual analogue scale (VAS) [ Time Frame: baseline, 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neck Pain and Disability Scale (NPAD, Wheeler 1999) [ Time Frame: baseline, 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]
health related quality of life (SF-36) [ Time Frame: baseline, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
patient expectation and self efficacy (questionnaire) [ Time Frame: Baseline, 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]
therapist's expectation [ Time Frame: baseline, 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]
undesired effects [ Time Frame: 3, 6, 12, and 24 months ] [ Designated as safety issue: Yes ]
semi-structured interviews to detect changes due to therapy and to assess the used questionnaires [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615732

Locations

Germany
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Claudia M Witt, MD

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

More Information

Responsible Party:	Institute for Social Medicine, Epidemiology, and Health Economics, Charité ( Claudia M. Witt, MD )
Study ID Numbers:	QENA-08
Study First Received:	February 1, 2008
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00615732
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

qigong
traditional chinese medicine
exercise therapy
neck pain

Study placed in the following topic categories:

Signs and Symptoms
Neck Pain
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009