Qigong and Exercise for Neck Pain in Adults (QENA)

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Neck Pain

Intervention / Treatment
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* Procedure: Qigong
* Procedure: exercise therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>qigong | Procedure: Qigong<br>* 18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week<br>|
| Active Comparator: 2<br>exercise therapy | Procedure: exercise therapy<br>* 18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week<br>|
| No Intervention: 3<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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qigong, traditional chinese medicine, exercise therapy, neck pain