Evaluation of the Effectiveness of Manual Maintenance Therapy (Chuna Maintenance Therapy) for Chronic Bothersome Neck Pain : a Multi-centered, Pragmatic Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- NRS (Numeric rating scale)
研究概览
简要总结
This study is a pragmatic randomized controlled study that assessed 250 subjects complaining of chronic bothersome neck pain with mild discomfort in a 1:1 ratio: chuna maintenance therapy group (125 subjects, 1 time/2 weeks, total 20 weeks) and lifestyle management & self-exercise group (125 subjects, exercise method education 1 time/4 weeks, total 20 weeks).
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
- •Inclusion Criteria:
- •Aged 19 or older but under
- •Neck pain with pain duration of 12 months or longer
- •NRS of neck pain over the past month is 2 or more but less than 4
- •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 progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
- •Patients whose pain is due to soft tissue disease not the spine (e.g. tumors, fibromyalgia, rheumatoid arthritis, gout)
- •Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcome (e.g. stroke and myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
- •Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
- •Pregnant patients or patients with plans of pregnancy or lactating patients
- •Patients within 3 months after cervical surgery
- •Patients with experience of participating in another clinical study within 1 month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the participation date
- •Patients having difficult to completing the written informed consent
- •Patients who are deemed unsuitable by the researchers
研究组 & 干预措施
Chuna maintenance therapy group
This group will receive chuna therapy determined by the clinician based on the subject's symptoms, degree of improvement, etc. (1 time/2 weeks, total 20 weeks)
干预措施: Chuna Maintenance Therapy (Procedure)
Lifestyle management & self-exercise group
This group will perform lifestyle management and daily self-exercise. The exercise education will be performed per 4 weeks for total 20 weeks.
干预措施: Chuna Maintenance Therapy (Procedure)
结局指标
主要结局
NRS (Numeric rating scale)
时间窗: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Ranging 0-10 likert scale (higher=worse)
NDI (Neck disability index)
时间窗: Wk 1, 5, 9, 13, 17, 21, 25
Each of the 10 items scores from 0 to 5, The maximum score is 50 (higher=worse)
次要结局
- VAS(Visual analogue scale) for pain(Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25)
- Number of days with bothersome neck pain(Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25)
- Recurrence(Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25)
- PGIC (Patient Global Impression of Change)(Wk 21, 25)
- EQ-5D-5L( The 5-level EuroQol-5)(Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25)
- HINT-8 (health-related quality of life instrument-8)(Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25)
- Rating for Credibility and Expectancy of the treatment(Once at screening procedure)
- Drug consumption history(Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25)