The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome : A Multicenter, Prospective, Case Series Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- VAS of low back pain
研究概览
简要总结
The purpose of this study is to investigate the effect of a non-surgical integrative package consisting of Chuna herbal medicine, Chuna manual therapy, bee-venom pharmacoacupuncture, acupuncture on failed back surgery syndrome through means of a prospective case series.
详细描述
The purpose of this study is to investigate the effect of a non-surgical integrative package on failed back surgery syndrome through means of a prospective case series.
After initial screening, treatment will be administered one session a week for 16 weeks. Patients will be followed up at 4 and 8 weeks after conclusion of treatment.
The integrative package 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
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from low back pain and/or leg pain that does not improve or the return of the symptoms within 1 year of spinal surgery
- •Low back pain and/or leg pain with duration at least 3 weeks at baseline
- •Low back pain and/or leg pain at least 60mm on VAS scale
- •Age between 18 and 60
- •Given consent to lumbar MRI
- •Voluntary participation with written consent given to study consent form
- •Given consent to not receive other treatment concerning pain due to spinal disorders during study participation period
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
integrative treatment
干预措施: Chuna herbal medicine (Drug)
integrative treatment
干预措施: Chuna manual therapy (Procedure)
integrative treatment
干预措施: Acupuncture (Procedure)
integrative treatment
干预措施: Bee-venom pharmacoacupuncture (Procedure)
结局指标
主要结局
VAS of low back pain
时间窗: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
VAS of radiating leg pain
时间窗: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
次要结局
- ODI (Oswestry Disability Index)(Baseline, 4th week, 8th week, 12th week, 16th week, 24th week)
- General assessment(patient/doctor)(16th week, 24th week)
- SF-36 (Quality of Life)(Baseline, 4th week, 8th week, 12th week, 16th week, 24th week)