Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
- Conditions
- Chronic Neck Pain
- Interventions
- Procedure: Doin (conduction exercise)Device: Acupuncture
- Registration Number
- NCT03009071
- Lead Sponsor
- Jaseng Medical Foundation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doin with Acupuncture Acupuncture 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. Acupuncture Acupuncture 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). Doin with Acupuncture Doin (conduction exercise) 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.
- Primary Outcome Measures
Name Time Method Change in Northwick Park Neck Pain Questionnaire (NPQ) 6 weeks from baseline Change in pain and functional disability questionnaire
- Secondary Outcome Measures
Name Time Method Cost per NRS Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 Economic evaluation
Drug Consumption Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)
Adverse events Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) Safety outcome
EuroQol-5 Dimension (EQ-5D) Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 Health-related quality of life questionnaire
Patient Global Impression of Change (PGIC) Week 4, 6, 9, 17, 29, 53 Global, patient-reported outcome
Short Form Health Survey 12 (SF-12) Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 Health-related quality of life questionnaire
Northwick Park Neck Pain Questionnaire (NPQ) Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 Pain and functional disability questionnaire
Numeric rating scale (NRS) of neck and arm pain Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 Pain scale
Visual analogue scale (VAS) of neck and arm pain Baseline (Week 1), Week 2, 3, 4, 5, 6 Pain scale
Neck Disability Index (NDI) Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 Functional disability questionnaire
Cost per QALY (quality-adjusted life year) Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 Economic evaluation
Trial Locations
- Locations (1)
Jaseng Medical Foundation
🇰🇷Seoul, Korea, Republic of