Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 7
- 主要终点
- Numeric rating scale (NRS) of neck pain
研究概览
简要总结
This is pilot study for a 3-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy, acupunture therapy and physical therapy, medication(prn) for cervical disc herniation.
详细描述
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture, the type and number of acupuncture and the type and time of physical therapy according to participants' conditions, respectively.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms of cervical disc herniation for less than 12 months
- •Numeric Rating Scale (NRS) of neck pain is more than 5
- •Symptoms of neuromuscular disease in one or both upper limbs (pain, pull, numbness, sensory abnormalities, motor abnormalities)
- •Discrimination findings above protusion, which can explain clinical symptoms on Cervical spine MRI or CT
- •19-69 years old
- •participants who agreed and wrote informed consents
排除标准
- •Case of being diagnosed with a specific serious disease that may cause neck pain(Migration of cancer reaching to spine, acute fracture of spine, spine dislocation)
- •Progressive neurologic deficits or severe neurologic deficits
- •Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.)
- •Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
- •Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
- •Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
- •Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
- •Pregnant, planning to get pregnant or lactating women
- •Participants who had undergone cervical surgery within 3 months
- •Participants who had participated in other clinical trial within 1 month, had participated in other study within 6 months from the date of selection, or have plan for participation in other trial during follow up period of this trial
- •Participants who can not write informed consent
- •Participants who is difficult to participate in the trial according to investigator's decision
研究组 & 干预措施
pharmacopunture therapy
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
干预措施: pharmacopuncture therapy (Procedure)
acupuncture therapy
The physicians will choose the type and number of acupuncture therapy according to participants' conditions.
干预措施: acupuncture therapy (Procedure)
physical therapy, medication(prn)
The physicians will choose the type and time of physical therapy according to participants' conditions. According to clinical judgment, clinicians can prescribe analgesics and muscle relaxants if necessary.
干预措施: physical therapy, medication(prn) (Procedure)
结局指标
主要结局
Numeric rating scale (NRS) of neck pain
时间窗: Week 1, 2, 3, 4, 5, 6, 7, 13, 25
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
次要结局
- Short Form-12 Health Survey version 2 (SF-12 v2)(Week 1, 7, 13, 25)
- Numeric rating scale (NRS) of radiating arm pain(Week 1, 2, 3, 4, 5, 6, 7, 13, 25)
- Visual analogue scale (VAS) of neck pain and radiating arm pain(Week 1, 2, 3, 4, 5, 6, 7, 13, 25)
- Neck Disability Index (NDI)(Week 1, 7, 13, 25)
- Northwick Park Questionnaire (NPQ)(Week 1, 7, 13, 25)
- Patient Global Impression of Change (PGIC)(Week 7, 13, 25)
- EuroQol-5 Dimension (EQ-5D-5L)(Week 1, 7, 13, 25)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation