Sustained Acoustic Medicine for Osteoarthritis Pain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 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 compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.
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 (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).
- •Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- •Are between 35-85 years of age
- •Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
- •Report that knee, shoulder, elbow, ankle, hip, or spine pain negatively affects quality of life
- •Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study
- •Are deemed appropriate by their physician or by the study site physician to participate.
- •Be 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 use or initiate opioid and/or non-opioid analgesic medications.
- •Be willing to discontinue any other interventional treatment modalities on the treatment area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
排除标准
- •Cannot successfully demonstrate the ability to put on and take off the device.
- •Displays 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.
- •Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- •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 a known neuropathy (disease of the brain or spinal nerves).
- •Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
- •Have knee, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months.
- •Requires oxygen support
- •Has an allergy to aspirin or other NSAIDs
- •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)
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: 2.5% Diclofenac Patches (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: Through study completion, average of 8 weeks
Change in the self described pain units on a scale by patient at baseline and post-
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Time Frame: Through study completion, average of 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. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).
次要结局
- Change in Global Rating of Change (GROC) on a Scale (-7 to +7)(Through study completion, average of 24 weeks.)
- Change in the Pain & Sleep Questionnaire (PSQ-3)(Through study completion, average of 24 weeks.)
- Change in Depression Anxiety Stress Scale (DASS21)(Through study completion, average of 24 weeks.)