Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone.

Detailed Description
-----------------
A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed by pain and functional disability scales, monitor its safety, and assess the feasibility of and serve as the basis for a full-scale, multicenter trial.

Official Title
-----------------
The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial

Conditions
-----------------
Chronic Neck Pain

Intervention / Treatment
-----------------
* Procedure: Doin (conduction exercise)
* Device: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Onset of at least 6 months previous for neck area pain Current neck area pain of Numeric Rating Scale (NRS) 5 or higher Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent Exclusion Criteria: Pathologies of non-spinal or soft tissue origin or high severity which may cause neck or radiating arm pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis, fibromyalgia, rheumatic arthritis, gout) Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness) Other chronic diseases which may interfere with treatment effect or interpretation of results (e.g. cardiovascular disorder, renal disease, diabetic neuropathy, dementia, epilepsy) Current intake of steroids, immunosuppressant medicine, psychiatric medicine or other medication which may interfere with treatment results Patients considered unsuitable or unsafe to receive acupuncture (e.g. patients with hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, severe diabetes with high risk of infection, severe cardiovascular diseases) Patients who were treated with invasive interventions such as acupuncture or injections, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week History of cervical surgery within the past 3 months Pregnancy or plans of pregnancy Severe psychopathy Participation in other clinical studies Inability to give written informed consent Other reasons rendering trial participation inappropriate as judged by the researchers

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doin with Acupuncture<br>An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise (rotation) as needed. | Procedure: Doin (conduction exercise)<br>* Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability. Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.<br>* Other names: Conduction Exercise;Device: Acupuncture<br>* Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.<br>|
| Active Comparator: Acupuncture<br>An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). | Device: Acupuncture<br>* Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Northwick Park Neck Pain Questionnaire (NPQ) | Change in pain and functional disability questionnaire | 6 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Northwick Park Neck Pain Questionnaire (NPQ) | Pain and functional disability questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | 
| Numeric rating scale (NRS) of neck and arm pain | Pain scale | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 | 
| Visual analogue scale (VAS) of neck and arm pain | Pain scale | Baseline (Week 1), Week 2, 3, 4, 5, 6 | 
| Neck Disability Index (NDI) | Functional disability questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | 
| EuroQol-5 Dimension (EQ-5D) | Health-related quality of life questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | 
| Patient Global Impression of Change (PGIC) | Global, patient-reported outcome | Week 4, 6, 9, 17, 29, 53 | 
| Short Form Health Survey 12 (SF-12) | Health-related quality of life questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | 
| Cost per QALY (quality-adjusted life year) | Economic evaluation | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | 
| Cost per NRS | Economic evaluation | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | 
| Drug Consumption | Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy) | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) | 
| Adverse events | Safety outcome | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neck Pain, Disability Evaluation, Costs and Cost Analysis, Doin Exercise Therapy, Acupuncture