Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability: a Randomised, Controlled, Trial Protocol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change from Baseline in numerical rating scale of back pain
研究概览
简要总结
Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in the treating pain and severe functional disability in acute LBP patients.
详细描述
58 patients with acute LBP and severe disability with an Oswestry Disability Index(ODI) of 60% or higher were randomly allocated and divided into 2 groups. The experimental group was treated with MSAT and the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session, and comparisons were made of measurements before and after treatment. Primary outcomes were measured by the NRS(numerical rating scale) of back pain in active movement. Secondary outcomes were measured by the NRS of radiating pain, ODI scores, and the patient's global impression of change(PGIC) etc. Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute LBP(with or without leg pain), with onset within past 4 weeks
- •Severe disability as assessed by an Oswestry Disability Index of 60% or higher
- •Age between 20 and 60
- •Given consent to lumbar MRI
- •Voluntary participation with written consent given to study consent form
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
acupuncture
MSAT is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture.
干预措施: acupuncture, injection (Other)
injections of diclofenac
the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session
干预措施: acupuncture, injection (Other)
结局指标
主要结局
Change from Baseline in numerical rating scale of back pain
时间窗: Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.
次要结局
- Change from Baseline in NRS of radiating pain, ODI scores, and the patient's global impression of change(PGIC),range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR)(Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)