The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease : Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- NRS of low back pain or neck pain/NRS of radiating pain
研究概览
简要总结
The purpose of this study is to investigate the effect of CAM treatments consisting of herbal medicine, Chuna manual therapy, pharmacoacupuncture, acupuncture on lumbar and cervical spine pain patients due to spinal disease.
详细描述
"The purpose of this study is to investigate the effect of CAM treatments on lumbar and cervical spine pain patients due to spinal disease.
After subjects selected by screening, who receive CAM treatments 1-2times a week for more than 2 months and F/U at 1st, 2nd, 3rd month by meeting and F/U at 6nd, 12nd month by calling.
The CAM treatments used in this study consists of 120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) and dried extracts in pill form(Cibotium barometz, Atractylodes japonica) taken twice a day 30 minutes after meals, Chuna manual therapy, intermuscular injections of bee-venom pharmacoacupuncture(Select 6 acupoints, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session), acupuncture and allow for NSAID intake during the investigational period. The subject is allowed a maximum of 3 pills/day, taken at a minimum of 8 hrs apart. The number of pills taken will be measured at 4 wks after conclusion of treatment."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from low back pain or Neck due to spinal disease Agree to the treatment of more than 2 months
- •Age all(If under 18yr, Guardian's consent need)
- •Volunteers do not have a problem with my speech as those who have signed the consent
排除标准
- •Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
- •Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
- •Progressive neurologic deficit(s) or concurrent severe neurological symptoms Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
- •Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
- •Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
- •During pregnancy or suspected pregnancy
- •Subjects considered unsuitable for clinical trial by the researcher
研究组 & 干预措施
CAM treatment
干预措施: Acupuncture (Procedure)
CAM treatment
干预措施: herbal medicine (Drug)
CAM treatment
干预措施: Chuna manual therapy (Procedure)
CAM treatment
干预措施: Bee-venom pharmacoacupuncture/pharmacoacupuncture (Procedure)
结局指标
主要结局
NRS of low back pain or neck pain/NRS of radiating pain
时间窗: Change from Baseline at 3rd month
次要结局
- Adverse reactions(Baseline, 1st month, 2nd month, 3rd month)
- ODI (Oswestry Disability Index)(Baseline, 1st month, 2nd month, 3rd month)
- Patient satisfaction(3rd month)
- Job loss(Baseline, 1st month, 2nd month, 3rd month)
- painkiller intaken of times(Baseline, 3rd month)