Can Botulinum Toxin Injection Relieve Pain and Improve Function in Patients With Functional Popliteal Artery Entrapment Syndrome?
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- VAS scores
研究概览
简要总结
Failure to adequately diagnose and treat patients with functional popliteal artery entrapment syndrome (PAES) leads to continued pain, loss of function and poor quality of life for many patients nationwide. Currently, the primary treatment for functional PAES involves muscle resection, sometimes involving large segments of muscle, which itself can lead to functional impairment. As such, a less invasive treatment for functional PAES is desirable. The focus of this work is to determine whether Botulinum toxin type A (BTX-A) injections into the gastrocnemius muscle can lessen the mechanical forces placed on the popliteal artery by the involved muscle, thereby improving symptoms caused by impaired distal blood flow.
详细描述
Ten (10) patients with suspected functional popliteal artery entrapment syndrome will be recruited for this study. Dr. Michael Fredericson will recruit patients from local sports medicine clinics and sports teams. Equal men and women will be recruited, between the age of 18 and 50 years. This subcategory will reduce the potential of recruiting patients with age-related confounding causes for their symptoms.
After patients have been identified as having clinical features suggestive of PAES, confirmation of the diagnosis will involve the following in accordance with standards of care: 1) Ankle-brachial index testing with provocative maneuvers (maximal passive dorsiflexion and maximal active plantarflexion, treadmill running at a slope), 2) MRI angiography with provocative maneuvers (maximal plantar and dorsiflexion).
All patients will also complete at baseline a visual analog scale (VAS) of their pain, a lower extremity functional scale (LEFS), and lower extremity ultrasound for evaluation of gastrocnemius muscle size.
Currently, treatment of functional PAES involves surgical intervention frequently involving resection of the gastrocnemius muscle. As part of this study, BTX-A will be administered to the gastrocnemius. Patients will be informed about the indications, contraindications, and adverse events associated with BTX-A injections, and they will be informed of current standard of care options, including surgical intervention. Written consent will be obtained.
Dr. Michael Fredericson will carefully inject BTX-A (Dysport-Ipsen Inc.) into the proximal third of the medial and lateral gastrocnemius muscles of the symptomatic leg(s). Total dose per leg will be 400 units, 200 per injection site. Injections will be performed with the aid of real-time ultrasound (Sonosite, Bothwell, WA) guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To participate in the intervention portion of the study, patients must have a confirmed diagnosis of functional PAES.
- •Patients must report ongoing leg pain during or after physical activity at the time of intervention.
- •Patients must have failed prior conservative treatment and have been experiencing exertional leg pain for > 6 months.
- •Patients must be between the age of 18 and 50.
排除标准
- •Any subject will be excluded from the study if he/she has any of the following:
- •History of muscle/tendon ruptures to the lower extremities
- •History of a neurological disease that would affect running or jogging
- •History of adverse reactions to BTX-A
- •Concomitant diagnosis of exertional compartment syndrome or other cause for leg pain.
研究组 & 干预措施
BTX-A injection
干预措施: Dysport (Drug)
结局指标
主要结局
VAS scores
时间窗: 12 weeks
Visual analog scale scores
Lower extremity functional scale scores
时间窗: 12 weeks
A patient-reported measure of 20 items used to evaluate the functional status in the presence of lower extremity musculoskeletal disorders
次要结局
- VAS scores(4 weeks, 18 weeks, and 6 months)
- Lower extremity functional scale scores(4 weeks, 18 weeks, and 6 months)
- blood flow on ankle-brachial indices(4 weeks, 12 weeks, and 6 months)
- gastrocnemius muscle size(4 weeks, 12 weeks, and 6 months)
研究者
Michael Fredericson
Director, Stanford PM&R Sports Medicine
Stanford University