Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this study is to determine if a newer tenotomy technique utilizing an ultrasound needle is more effective than the traditional tenotomy technique utilizing a simple hypodermic needle for gluteal tendinosis. The main questions it aims to answer are:
- Is pain from the gluteal tendinosis improved with either technique, and, if so, is there a difference in the improvement between techniques?
- Is there an improvement in function for gluteal tendinosis, and, if so, is there a difference between techniques?
详细描述
Study Design This study is designed as a single-blinded, randomized control trial with two parallel arms comparing PNT vs PUT device for the treatment of gluteal (medius and minimus) tendinosis with analysis of pain, physical function, activities of daily living (ADLs) and overall health over four months. Participants will be randomly assigned (1:1) to receive PNT or PUT at one academic medical center. Each participant will be assigned a patient ID and randomized to one of the two groups. The participants and outcomes assessors will be blinded to treatment group allocation, but the physician administering treatment will not be blinded.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gluteal (medius and/or minimus) tendinosis confirmed clinically and with ultrasonography or MRI
- •Failure to improve after 3 months of nonoperative treatment
- •Symptoms present for longer than 3 months
排除标准
- •Patients with concomitant injuries or pain
- •Full thickness tears of the affected tendon
- •Prior corticosteroid injection of the affected tendon within the last 3 months
- •Prior PNT of the affected tendon
- •Significant abnormalities of bony or tendon morphology
研究组 & 干预措施
Percutaneous needle tenotomy (PNT)
Traditional tenotomy technique utilizing a hypodermic needle.
干预措施: Percutaneous needle tenotomy (PNT) (Procedure)
Percutaneous ultrasonic tenotomy (PUT, Tenex device)
Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex)
干预措施: Percutaneous ultrasonic tenotomy (PUT, Tenex Device) (Device)
结局指标
主要结局
Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
时间窗: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.
The VAS measures the severity of pain. Scores range from 0 to 100 mm line with 0 representing no pain and 100 representing the worst pain imaginable.
次要结局
- Change from baseline in physical function, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function grading scale for activities of daily living (ADLs)(Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.)