NCT06102798招募中不适用
The Efficacy and Safety of Acupuncture in Relieving Neurogenic Claudication Among Patients With Lumbar Spinal Stenosis: a Randomized Controlled Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2023年11月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- The proportion of participants who achieves at least 30% improvement in total walking distance from baseline.
研究概览
简要总结
The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnosis criteria of LSS;
- •Aged between 50-80 years;
- •Neurogenic claudication (NC) for more than 3 months;
- •Able to walk for at least 20 meters continually without device assistance, and forced to stopped walking out of NC within 30 mins in the meanwhile;
- •The average pain of buttocks and/or legs scores≥4 on the Numerical Rating Scale (NRS) when walking, standing, or extending the back in the past week;
- •More severe pain in the buttock and/or leg than in the lower back;
- •Score at least 7 on Modified Roland-Morris Disability Questionnaire（RMDQ）;
- •Central sagittal diameter stenosis of lumbar spinal canal as manifested by MRI or CT scan;
- •Volunteer to participate the trial and provide written informed consent.
排除标准
- •Non-degenerative LSS, such as congenital, post-traumatic or spondylolisthesis LSS; operation indications, such as segmental muscular atrophy, bowel and bladder disfunction, and spinal instability; tuberculosis or tumor in the lumbar area; or multiple vertebral compression fracture or compression fracture in the segment of stenosis;
- •Vascular claudication;
- •Severe heart, pulmonary, liver and/or kidney diseases;
- •Clinical comorbidities that may interfere with the assessment of pain intensity or walking ability, such as fibromyalgia, chronic widespread pain, amputation, stroke, Parkinson's disease, spinal cord injury, severe diabetes, and severe hypertension etc;
- •Unable to complete motorized treadmill test at the speed of 2km/h;
- •Severe psychiatric disorder or cognitive impairment that prevent the understanding of the outcome evaluating questionnaires;
- •A history of lumbar surgery;
- •Have received acupuncture treatments in the previous 2 weeks;
结局指标
主要结局
The proportion of participants who achieves at least 30% improvement in total walking distance from baseline.
时间窗: Weeks 6 and 18
The total walking distance is defined as the distance that participants forced to stop due to symptoms of neurogenic claudication or a time limit of 30 minutes during the motorized treadmill test (MTT).
次要结局
- The proportion of participants who achieved at least 50% improvement in total walking distance from baseline.(Weeks 6 and 18)
- The change in the time to first symptoms from baseline.(Weeks 6 and 18)
- The proportion of participants who are satisfied with the treatment based on the satisfaction domain of the SSSQ.(Weeks 6,18 and 30)
- The change in final pain intensity from baseline.(Weeks 6 and 18)
- The change in recovery time from baseline.(Weeks 6 and 18)
- The change from baseline in the index score of European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).(Weeks 6,18 and 30)
- The proportion of participants who have at least 50% reduction from baseline in the average scores of buttocks and/or legs pain when walking, standing, or extending the back in the past week as measured by the Number Rating Scale (NRS).(Weeks 6,18 and 30)
- The change in total walking distance from baseline.(Weeks 6 and 18)
- The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline.(Weeks 6,18 and 30)
- The change in the time to first moderate pain symptom from baseline.(Weeks 6 and 18)
- Changes from baseline in the average score of buttocks and/or legs pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week.(Weeks 6,18 and 30)
- Changes in the average score of lower back pain when walking, standing, or extending the back as measured by the NRS in the previous 1 week from baseline.(Weeks 6,18 and 30)
- The change from baseline in the domain scores (symptom severity and physical function) of Swiss Spinal Stenosis Questionnaire (SSSQ).(Weeks 6,18 and 30)
- The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).(Weeks 6,18 and 30)
研究者
Liu Zhishun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Efficacy Study of Acupuncture to Treat Spinal PainLow Back PainNCT01909284Daegu Catholic University Medical Center14
已完成
不适用
Acupuncture for Residual Insomnia Associated With Major Depressive DisorderInsomniaDepressionNCT00838994The University of Hong Kong78
已完成
不适用
Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic PainNeuralgiaPostherpetic NeuralgiaDiabetic Neuropathy, PainfulFailed Back Surgery SyndromeNCT03315598Seoul National University22
已完成
不适用
Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care UnitAgitationNCT01848158Seattle Children's Hospital17
已完成
不适用
Acupuncture for Chemotherapy-induced Peripheral NeuropathyChemotherapy Induced Peripheral NeuropathyNCT03582423Hong Kong Baptist University60