The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Northwick Park Neck Pain Questionnaire (NPQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Doin with 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.
干预措施: Doin (conduction exercise) (Procedure)
Doin with 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.
干预措施: Acupuncture (Device)
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).
干预措施: Acupuncture (Device)
结局指标
主要结局
Change in Northwick Park Neck Pain Questionnaire (NPQ)
时间窗: 6 weeks from baseline
Change in pain and functional disability questionnaire
次要结局
- Cost per NRS(Baseline (Week 1), Week 4, 6, 9, 17, 29, 53)
- Drug Consumption(Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit))
- Adverse events(Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit))
- EuroQol-5 Dimension (EQ-5D)(Baseline (Week 1), Week 4, 6, 9, 17, 29, 53)
- Patient Global Impression of Change (PGIC)(Week 4, 6, 9, 17, 29, 53)
- Short Form Health Survey 12 (SF-12)(Baseline (Week 1), Week 4, 6, 9, 17, 29, 53)
- Northwick Park Neck Pain Questionnaire (NPQ)(Baseline (Week 1), Week 4, 6, 9, 17, 29, 53)
- Numeric rating scale (NRS) of neck and arm pain(Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53)
- Visual analogue scale (VAS) of neck and arm pain(Baseline (Week 1), Week 2, 3, 4, 5, 6)
- Neck Disability Index (NDI)(Baseline (Week 1), Week 4, 6, 9, 17, 29, 53)
- Cost per QALY (quality-adjusted life year)(Baseline (Week 1), Week 4, 6, 9, 17, 29, 53)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation