NCT03558178已完成不适用
The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: A Multi-center Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 10
- 主要终点
- Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
研究概览
简要总结
A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain
详细描述
A multi-center randomized controlled, parallel, assessor-blinded full-scale trial will be conducted based on the results of the pilot study to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.
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
- •Neck area pain duration of 6 months or longer
- •Current Numeric Rating Scale (NRS) for neck area pain of 5 or higher
- •Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent
排除标准
- •Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis)
- •Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
- •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)
- •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
结局指标
主要结局
Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
时间窗: Week 5 post-baseline (screening)
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
次要结局
- Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively(Week 1, 2, 3, 4, 5, 6 post-baseline (screening))
- Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively(Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively(Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Drug Consumption (drug dose)(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Economic evaluation (time-related costs)(Week 2 post-baseline (screening))
- Economic evaluation (lost productivity costs)(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Credibility and Expectancy Questionnaire(Week 1 post-baseline (screening))
- Other treatments (treatment frequency)(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively(Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively(Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Physical examination(Week 1, 6 post-baseline (screening))
- Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively(Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Economic evaluation (medical costs)(Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Other treatments (treatment type)(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Patient Global Impression of Change (PGIC)(Week 6, Month 3, 6, 9, 12 post-baseline (screening))
- Drug Consumption (drug type)(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Adverse events(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit))
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation
研究点 (10)
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