Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- Avazzia, Inc
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Level Assessment
研究概览
简要总结
A clinical study at the Dallas Veterans Affairs, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® device by AVAZZIA to reduce pain and increase activity level in patients with knee osteoarthritis.
详细描述
The primary objective of this study is to document the possible short- and long-term decrease in pain as scored by participants on a Numeric Rating Scale (NRS) after use of Avazzia PRO-Sport Ultra® device with pulsed microcurrent in patients with osteoarthritis of the knee.
Patients with a clinical diagnosis of Osteoarthritis (OA) of the knee for a minimum of 6 months will be recruited for this study. Their OA has not responded/is not responding to treatment and continuing symptoms interfere with normal function. Additionally, patients will have a pain score of 3 or greater on the NRS even with pain medication.
Secondary objectives include changes in:
- Mobility via a Timed Up & Go assessment (TUG). Participants are timed getting up from sitting in a standard armchair, walking approximately 3 meters, turning, walking back to the chair, and sitting down.
- Patient-relevant outcomes via the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
- Brief Pain Inventory - Short Form
- Use of pain medication.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a prior diagnosis (Dx) of OA of the knee and have had a trial of conservative treatment for a minimum of 6 months without successful results due to continuing symptoms that interfere with normal function
- •Age >18 - <70 years old
- •Males/Females of all ethnicities
- •NRS pain score of 3 or greater while on medication
- •Ability to understand the informed consent document before signing it
- •For female participants, is at least 4 years post-menopausal, has a history of hysterectomy, has had bilateral tubal ligation, or consents to use two forms of birth control.
排除标准
- •Poor diabetic control (A1c>11 within the last 3 months)
- •Diagnosis of acute sciatica and/or acute vasculitis
- •Diabetic peripheral neuropathy
- •Lower extremity surgery within the last 6 months
- •Knee replacement
- •Uncontrolled mood disorders, such as depression, anxiety
- •Drug or substance abuse within past 90 days
- •Injury that results in a change in pain level due to causes other than osteoarthritis (i.e., a recent fall or accident)
- •Open wounds around knee joint
- •Active litigation, workers compensation
- •An electrically implanted device such as a pacemaker, neural stimulator, etc.
- •Currently pregnant, nursing, or may become pregnant.
结局指标
主要结局
Pain Level Assessment
时间窗: 12 weeks
Change in pain associated with osteoarthritis of the knee during all visits (#1-13). Pain will be assessed with NRS (numeric rating scale) where 0 is no pain and 10 is worst possible pain.
次要结局
- Changes in patient-relevant outcomes(12 weeks)
- Changes in mobility(12 weeks)
- Changes in the use of pain medication(12 weeks)
- Changes in brief pain inventory(12 weeks)