NCT02466308已完成不适用
Long Duration Therapeutic Ultrasound for Tendon Healing
ZetrOZ, Inc.2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pain (Numeric Rating Scale; NRS)
研究概览
简要总结
ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •18-65 years of age, inclusive
- •Diagnosis of tendinitis in the elbow (lateral or medial epicondyle), Achilles tendon, or patellar tendon based on examination of medical history and confirmed by physical examination including either manual movements of the injured limb, e.g., a positive Mill's Test for elbow tendinitis, or local tenderness upon palpation of the tendon;
- •Body mass index (BMI) less than or equal to 30.0
- •Not taking NSAIDs or prescription pain medications for their tendinitis, and agree to document all pain medication use during the study period.
排除标准
- •History or current diagnosis of tendon tear in treated tendon
- •Known neuropathy
- •Type I or Type II diabetes mellitus
- •Had surgery in target treatment area within 6 months
- •Refuse to agree to not increase current use or initiate new use of pain medication during the trial unless medically necessary to ensure patient safety
- •Refuse to agree to not use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided
- •Refuse to discontinue all other interventional treatment modalities (e.g., transcutaneous electrical nerve stimulation, other ultrasound therapy, etc.)
- •Have had a local corticosteroid or platelet-rich plasma injection within the past 3 months
- •Have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
结局指标
主要结局
Pain (Numeric Rating Scale; NRS)
时间窗: Change from Baseline to Week 6
次要结局
- Pain (NRS): 50% response rate(Week 6)
- Pain (NRS) during treatment session(Pre-treatment to Post-treatment (4 hours))
- Treatment Compliance (subject-reported use of device compared to protocol)(weekly through Week 6)
- Grip Strength (dynamometer)(Change from Baseline to Week 6)
研究者
研究点 (2)
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