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

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Qigong
exercise therapy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring qigong, traditional chinese medicine, exercise therapy, neck pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

1

2

3

Arm Description

qigong

exercise therapy

Outcomes

Primary Outcome Measures

average pain intensity during the last 7 days measured on a visual analogue scale (VAS)

Secondary Outcome Measures

Neck Pain and Disability Scale (NPAD, Wheeler 1999)
health related quality of life (SF-36)
patient expectation and self efficacy (questionnaire)
therapist's expectation
undesired effects
semi-structured interviews to detect changes due to therapy and to assess the used questionnaires

Full Information

First Posted
February 1, 2008
Last Updated
July 9, 2012
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00615732
Brief Title
Qigong and Exercise for Neck Pain in Adults (QENA)
Acronym
QENA
Official Title
Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
qigong, traditional chinese medicine, exercise therapy, neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
qigong
Arm Title
2
Arm Type
Active Comparator
Arm Description
exercise therapy
Arm Title
3
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Qigong
Intervention Description
18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
Intervention Type
Procedure
Intervention Name(s)
exercise therapy
Intervention Description
18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Neck Pain and Disability Scale (NPAD, Wheeler 1999)
Time Frame
baseline, 3, 6, 12, and 24 months
Title
health related quality of life (SF-36)
Time Frame
baseline, 3, 6, 12 and 24 months
Title
patient expectation and self efficacy (questionnaire)
Time Frame
Baseline, 3, 6, 12, and 24 months
Title
therapist's expectation
Time Frame
baseline, 3, 6, 12, and 24 months
Title
undesired effects
Time Frame
3, 6, 12, and 24 months
Title
semi-structured interviews to detect changes due to therapy and to assess the used questionnaires
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Witt, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21178832
Citation
Rendant D, Pach D, Ludtke 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.
Results Reference
result

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Qigong and Exercise for Neck Pain in Adults (QENA)

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