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

July 9, 2012 updated by: Claudia M. Witt, Charite University, Berlin, Germany

Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 3
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Claudia M Witt, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QENA-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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