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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.
 
ClinicalTrials.gov Identifier: NCT00615732
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE February 1, 2008
First Posted Date  ICMJE February 14, 2008
Last Update Posted Date July 10, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
average pain intensity during the last 7 days measured on a visual analogue scale (VAS) [ Time Frame: baseline, 3, 6, 12, and 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00615732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • Neck Pain and Disability Scale (NPAD, Wheeler 1999) [ Time Frame: baseline, 3, 6, 12, and 24 months ]
  • health related quality of life (SF-36) [ Time Frame: baseline, 3, 6, 12 and 24 months ]
  • patient expectation and self efficacy (questionnaire) [ Time Frame: Baseline, 3, 6, 12, and 24 months ]
  • therapist's expectation [ Time Frame: baseline, 3, 6, 12, and 24 months ]
  • undesired effects [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Qigong and Exercise for Neck Pain in Adults (QENA)
Official Title  ICMJE Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Neck Pain
Intervention  ICMJE
  • Procedure: Qigong
    18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
  • Procedure: exercise therapy
    18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
Study Arms  ICMJE
  • Experimental: 1
    qigong
    Intervention: Procedure: Qigong
  • Active Comparator: 2
    exercise therapy
    Intervention: Procedure: exercise therapy
  • No Intervention: 3
Publications * Rendant D, Pach D, Lüdtke R, Reisshauer A, Mietzner A, Willich SN, Witt CM. Qigong versus exercise versus no therapy for patients with chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2011 Mar 15;36(6):419-27. doi: 10.1097/BRS.0b013e3181d51fca.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2012)
123
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2008)
120
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00615732
Other Study ID Numbers  ICMJE QENA-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claudia M. Witt, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claudia M Witt, MD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP