NCT03800927已完成不适用
Multi Week Long-Duration Ultrasound for Knee Osteoarthritis
ZetrOZ, Inc.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Pain Units on a Numeric Rating Scale (NRS)
研究概览
简要总结
This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are you between 18 and 80 years of age (inclusive)?
- •Can you speak, read, and write in English?
- •Do you have knee pain that has lasted at least 3 months?
- •Are you willing and able to self-administer the ultrasound device daily within your place of residence or during normal daily activity?
- •Are you willing to keep all pain medications stable and discuss with the investigator any needs to change medications during the study period? This may include drugs administered topically, orally, transdermally, or by injection.
- •Are you willing to document usage of any medications during the study period?
- •Do you agree to discontinue all other interventional treatment modalities on the lower back during the study? (e.g., transcutaneous electric nerve stimulation [TENS], electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic services)
- •On a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (pain as bad as you can imagine), how would you rate your average pain over the past week? Pain must be ≥4 for the subject to be enrolled in this study. This criterion will be assessed by self-report at Visit 1.
排除标准
- •Have you participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening?
- •Are you pregnant?
- •Are you a prisoner?
- •Are you non-ambulatory (unable to walk)?
- •Do you have a pacemaker?
- •Do you have a malignancy in the treatment area?
- •Do you have an active infection, open sores, or wounds in the treatment area?
- •Do you have impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia?
- •Do you have a known neuropathy (disease of the brain or spinal nerves)?
- •Do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)?
- •Do you have peripheral artery disease?
- •Does the subject display any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions?
研究组 & 干预措施
Sham Ultrasound Device
Placebo Comparator
No ultrasound treatment
干预措施: Long duration ultrasound (Device)
Active Ultrasound Device
Active Comparator
Active treatment
干预措施: Long duration ultrasound (Device)
结局指标
主要结局
Change in Pain Units on a Numeric Rating Scale (NRS)
时间窗: Average of first week (start of study) to average measure at 24 weeks (end of study)
NRS on the scale of 1 - 10, 1 being minimum and 10 being maximum, Change was calculate from base line
次要结局
- Function(First week (start of study) to 24 weeks (end of study))
- Strengthen(First week (start of study) to 24 weeks (end of study))
- Range of motion(First week (start of study) to 24 weeks (end of study))
研究者
研究点 (2)
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