Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
研究概览
简要总结
The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
- •Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- •35-80 years of age
- •Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment
- •Report that knee pain negatively affects quality of life
- •Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
- •Deemed appropriate by their physician or by the study site physician to participate
- •Willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device
- •Not initiate use of opioid and/or non-opioid analgesic medications
- •Willing to discontinue any other interventional treatment modalities on the knee during the study period
排除标准
- •Cannot successfully demonstrate the ability to put on and take off the device
- •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
- •Have severe OA or have little to no cartilage in the knee
- •Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- •Is non-ambulatory (unable to walk)
- •Is pregnant
- •Is a prisoner
- •Has a pacemaker
- •Has a malignancy in the treatment area
- •Has an active infection, open sores, or wounds in the treatment area
- •Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia
- •Has known neuropathy
- •Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage)
- •Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
- •Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
- •Currently taking steroids
- •Have contraindication to radiograph
- •Have a secondary cause of arthritis (metabolic or inflammatory)
研究组 & 干预措施
SAM Ultrasound Device and Diclofenac Patch
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: Sustained Acoustic Device with 2.5% Diclofenac Patch (Device)
SAM2 Ultrasound Device and Diclofenac Patch
Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
干预措施: Sustained Acoustic Device with 2.5% Diclofenac Patch (Device)
Topical Pain-Relief Gel
Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
干预措施: 1% Diclofenac Topical Gel (Drug)
结局指标
主要结局
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
时间窗: 8 weeks
Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline
时间窗: 8 weeks
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.
次要结局
未报告次要终点