NCT04539184已完成不适用
The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute 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
- 128
- 试验地点
- 6
- 主要终点
- Visual Analogue Scale(VAS) on movement
研究概览
简要总结
The investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture.
详细描述
This is a multi-center, randomized, controlled, comparative effectiveness clinical trial for acute neck pain. Motion style acupuncture requires a part of the patient's body to move passively or actively while acupuncture needles are retained.
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 pain onset or worsen within one month
- •VAS of neck pain on movement or at rest of 5 or higher
- •Age between 19 and 70 years old
- •Participants who wrote a informed consent
排除标准
- •Participants who diagnosed with the serious disease that can cause pain (e.g. Migration of cancer reaching to spine, fracture of spine, dislocation of spine)
- •Progressive neurologic deficits or severe neurologic deficits
- •Participants who diagnosed with a soft tissue disease that can cause pain (Cancer, fibromyalgia, RA, or goat)
- •Chronic disease (e.g. Cardiovascular disease, kidney disease, dementia, diabetic neuropathy, or epilepsy)
- •Participants taking steroids, immunosuppressants, or psychotropic medication
- •Participants who could be inadequate or unsafe at acupuncture (e.g. Hemorrhagic disease, severe diabetes or taking anticoagulant drug)
- •Participants who took NSAIDs or acupuncture within 3 days
- •Participants who had undergone cervical surgery within 3 months
- •Participants who had a traffic accident within a month
- •Pregnant or women who planned to conceive
- •Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial within 6 months from enrollment
- •Participants who can not write informed consent
- •Participants who is difficult to participate in the trial according to investigator's decision
结局指标
主要结局
Visual Analogue Scale(VAS) on movement
时间窗: Change from baseline VAS at 3 weeks
Minimum 0, Maximum 100. Higher values represent a worse outcome
次要结局
- Patient Global Impression of Change (PGIC)(Week 3, 8)
- Range of movement (ROM) of flexion(Baseline(Week 1), Week 2, 3, 8)
- Drug Consumption(Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit))
- EQ-5D-5L(Baseline(Week 1), 3, 8)
- Range of movement (ROM) of Rt rotation(Baseline(Week 1), Week 2, 3, 8)
- Range of movement (ROM) of Lt lateroflexion(Baseline(Week 1), Week 2, 3, 8)
- Range of movement (ROM) of Rt lateroflexion(Baseline(Week 1), Week 2, 3, 8)
- Visual Analogue Scale (VAS) on movement(Baseline(Week 1), Week 2, 3, 8)
- Northwick Park Neck Pain Questionnaire (NPQ)(Baseline(Week 1), Week 2, 3, 8)
- Range of movement (ROM) of Lt rotation(Baseline(Week 1), Week 2, 3, 8)
- 12-item Short-Form Health Survey (SF-12)(Baseline(Week 1), 3, 8)
- Adverse events(Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit))
- Range of movement (ROM) of extension(Baseline(Week 1), Week 2, 3, 8)
- Visual Analogue Scale (VAS) at rest(Baseline(Week 1), Week 2, 3, 8)
- Numeric Rating Scale (NRS) on movement(Baseline(Week 1), Week 2, 3, 8)
- Numeric Rating Scale (NRS) at rest(Baseline(Week 1), Week 2, 3, 8)
- Vernon-Mior Neck Disability Index (NDI)(Baseline(Week 1), Week 2, 3, 8)
- EuroQol Visual Analogue Scale (EQ-VAS)(Baseline(Week 1), 3, 8)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation
研究点 (6)
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