Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 5
- 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 Chuna manual therapy for chronic neck pain
详细描述
A multi-center randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain patients compared to usual care 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic neck pain patients (with pain duration of 3 months or longer)
- •Patients with numeric rating scale (NRS) of radicular pain ≤ neck pain in neck pain patients with or without radiculopathy
- •Patients with NRS of neck pain ≥5 during the 3 days
- •Patients who have agreed to trial participation and provided written informed consent
排除标准
- •Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
- •Patients with history of neck surgery
- •Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcomes (e.g. chronic renal failure, vertebral artery complications, rheumatoid arthritis, Down syndrome)
- •Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
- •Patients with severe mental illness
- •Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
- •Patients who have received Chuna manual therapy or physical therapy, medicine such as nonsteroidal anti-inflammatory drugs (NSAIDs), or treatment(s) that may influence pain within the past week
- •Pregnant patients or patients with plans of pregnancy
- •Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
研究组 & 干预措施
Chuna manual therapy
The Chuna manual therapy group will receive Chuna manual therapy alone. Chuna manual therapy will employ a semi-standardized treatment plan of Chuna manual therapy through Chuna technique selection based on physician judgement of techniques from Chuna Medicine (Korean Society of Chuna Manual Medicine for Spine & Nerves: Chuna Medicine: Seoul: Korean Society of Chuna Manual Medicine for Spine & Nerves; 2017) and osteopathic manipulative medicine. The Chuna techniques employed in this study are divided into cervical, thoracic and rib cage, lumbar, pelvic, sacral, pubic, and hip joint area techniques. Chuna manual therapy sessions will be administered 2 sessions/week over a period of 5 weeks (total 10 sessions). The time duration of 1 Chuna manual therapy session will consist of approximately 10-20 minutes of diagnosis and approximately 10 minutes of treatment.
干预措施: Chuna manual therapy (Procedure)
Usual care
The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.
干预措施: Conventional medication (Drug)
Usual care
The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.
干预措施: Physical therapy (Procedure)
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 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 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 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))
- Economic evaluation (medical costs)(Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Economic evaluation (time-related costs)(Week 2 post-baseline (screening))
- Patient Global Impression of Change (PGIC)(Week 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))
- Adverse events(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit))
- 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))
- Drug Consumption(Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening))
- Physical examination(Week 1, 6 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))
- 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 EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively(Week 1, 6 post-baseline (screening))
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation