Acupuncture for Lumbar Spinal Stenosis: a Parallel, Randomized Controlled Pilot Study With Usual Care Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mid-term Back specific functional status
研究概览
简要总结
Acupuncture is widely used to manage chronic low back pain. Mounting evidence suggests the beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor adverse events. However, little information exists regarding the effects and safety of acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that present chronic low back and leg pain.
The investigators aimed to assess the overall effectiveness, safety, and feasibility of acupuncture in combination with usual care (as opposed to usual care alone) for patients with symptomatic degenerative lumbar spinal stenosis.
The hypotheses of this study are as follows:
- A set of acupuncture sessions in combination with usual care can provide greater functional improvements than usual care alone .
- A set of acupuncture sessions in combination with usual care can provide greater pain reduction than usual care alone .
The study aims to include 50 participants (25 in the acupuncture group and 25 in the usual care group).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 40
- •Pain or bothersomeness of lower back or leg began at least three months ago (with at least 40 of pain or bothersomeness visual analogue intensity at the time of recruitment; 0 refers to no pain or bothersomeness and 100 to worst pain or bothersomeness imaginable)
- •Clinical features of lumbar spinal stenosis, including neurological claudication or postural symptom changes
- •Lumbar spinal stenosis confirmed by radiologic examination (e.g., computed tomography or magnetic resonance imaging) within the last two years
- •Willingness to participate in the study
排除标准
- •Congenital spinal stenosis
- •Other spinal deformities, including spinal fractures and infections
- •Participants who have received spinal surgeries, such as laminectomy, spinal fusion, and discectomy, due to lumbar spinal stenosis or other spinal diseases
- •Other surgeries which might influence clinical features of lumbar spinal stenosis (e.g., total hip/knee replacements)
- •Comorbid conditions which might interfere with the participant's active participation in the study (i.e., poorly controlled hypertension, poorly controlled diabetes mellitus, severe coronary artery disease, unstable asthma, cognitive function disorders, and other disabling conditions that interfere with self-ambulation, such as severe hip or knee arthritis)
- •Past/present history of malignancy
- •Began a new intervention for the management of lumbar spinal stenosis within the last one month
- •Cauda equine syndrome (progressive lower extremity muscle weakness, loss of bowel/bladder control, and/or perianal numbness) and other urgent conditions which require immediate surgery
- •Other conditions not appropriate for study participation
结局指标
主要结局
Mid-term Back specific functional status
时间窗: 3 months
Participant-perceived reduction of pain and physical function will be measured with a 10-item questionnaire; change from baseline in the Oswestry Disability Index (ODI) scale will be used.
次要结局
- Short-term low back pain intensity(6 weeks)
- Short-term leg pain bothersomeness(6 weeks)
- Short-term Back specific functional status(6 weeks)
- Short-term leg pain intensity(6 weeks)
- Short-term low back pain bothersomeness(6 weeks)
- Mid-term pain-related quality of life(3 months)
- Mid-term physical function-related quality of life(3 months)
- Use of medication and healthcare resources(6 weeks, 3 months)
- Adverse events(6 weeks, 3 months)
- Mid-term low back pain bothersomeness(3 weeks)
- Mid-term low back pain intensity(3 weeks)
- Mid-term leg pain bothersomeness(3 months)
- Mid-term leg pain intensity(3 months)
- Short-term pain-related quality of life(6 weeks)
- Patient satisfaction for treatment outcome(6 weeks, 3 months)
- Patient Global Assessment for treatment outcome(6 weeks, 3 months)
- Short-term physical function-related quality of life(6 weeks)
- Self-reported pain-free walking distance(6 weeks, 3 months)
研究者
Gi Young Yang
Assistant Professor
Korean Medicine Hospital of Pusan National University