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临床试验/NCT05254470
NCT05254470已完成不适用

Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care

ZetrOZ, Inc.1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年9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
135
试验地点
1
主要终点
Numeric Pain Rating Scale (NRS) (0-10)

研究概览

简要总结

The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow.

Low-intensity continuous ultrasound (LICUS) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. The objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care.

详细描述

ZetrOZ's SAM Ultrasound Device is a portable and wearable medical device which, when applied to various areas of the body, applies Low Intensity Therapeutic Ultrasound to deep tissues. The SAM device is currently used by a broad range of Athletic Trainers (ATs) in the United States to assist in the rehabilitation of injured athletes.

The purpose of this this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care. This includes understanding utilization of the treatment (how often and how much time), how the treatment helps patients (rehabilitation and recovery), and information on SAM treatment augmenting conservative therapies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Work-related musculoskeletal injuries with limited improvement under traditional therapies

排除标准

  • •Healthy participant

结局指标

主要结局

Numeric Pain Rating Scale (NRS) (0-10)

时间窗: 0 - 4 weeks

Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain.

次要结局

  • Global Health Improvement Score (GROC) (-7 to +7)(0 - 4 weeks)

研究者

发起方
ZetrOZ, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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