Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation With Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Numeric rating scale (NRS) out of neck pain and radiating arm pain
研究概览
简要总结
A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in cervical disc herniation patients with neck pain or cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, work loss and quality of life patient-reported outcomes
详细描述
This is a prospective observational study to the aim of investigating the effectiveness and safety of integrative Korean medicine treatment (generally consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in cervical disc herniation patients with neck pain or cervical radiculitis diagnosed by cervical MRI and clinical symptoms including cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Bucheon, Daejeon, Haeundae) as assessed through of pain, functional disability, work loss, and quality of life patient-reported outcomes with a 5-year follow-up period
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age between 19 years ~ 65 years
- •Patients with one arm pain or both side arm pain or neck pain with intensity of NRS ≥6 which occurred less then 12 month before
- •Patients with cervical radiculopathy symptoms of one or both side of arms
- •Patients diagnosed with cervical disc herniation with over protrusion degree of prolapsed inter-vertebral disc assessed on MRI
- •Patients with plans of receiving Korean medicine treatment for cervical disc herniation for ≥2 months
- •Patients who have agreed to study participation
排除标准
- •Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- •Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause neck pain or radiating arm pain (e.g. spinal tumor, rheumatoid arthritis)
- •Patients with medical history of cervical myelopathy which can cause neck pain or radiating arm pain
- •Patients with medical history of surgery in relation with cervical disc herniation
- •Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anticoagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
- •Pregnant patients or patients planning pregnancy
- •Patients with serious psychological disorders
- •Patients unable to fill out study participation consent form
- •Patients deemed unsuitable for study participation as assessed by the researchers
结局指标
主要结局
Change in Numeric rating scale (NRS) out of neck pain and radiating arm pain
时间窗: Time Frame: Change from baseline to 4 months
Change from higher score at baseline out of neck pain or radiating arm pain intensity to same score at 4 months. Total score range: -10 (worse outcome) to 10 (better outcome) Total score range: -10 (worse outcome) to 10 (better outcome)
次要结局
- Visual analogue scale (VAS) of radiating arm pain(Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Type and frequency of other intervention(s)(Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Type and frequency of adverse reaction(s)(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Numeric rating scale (NRS) of Neck pain(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- EQ-VAS([Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years])
- Visual analogue scale (VAS) of neck pain(Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- EuroQol 5-dimensions 5-levels (EQ-5D-5L)(Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Physical examination(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Neck Disability Index (NDI)(Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Patient Global Impression of Change (PGIC)(Time Frame: 8, 16, 20, 24 weeks, 1, 3, 5 years)
- Numeric rating scale (NRS) of radiating arm pain(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- SF-36(Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
研究者
In-Hyuk Ha, KMD
K.M.D, Rehabilitation Medicine Specialist
Jaseng Medical Foundation