Qigong and Exercise for Neck Pain in Adults (QENA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00615732
First received: February 1, 2008
Last updated: July 9, 2012
Last verified: July 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 123
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
qigong
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

  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 Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00615732     History of Changes
Other Study ID Numbers: QENA-08
Study First Received: February 1, 2008
Last Updated: July 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
qigong
traditional chinese medicine
exercise therapy
neck pain

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

ClinicalTrials.gov processed this record on April 17, 2014