Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4
研究概览
简要总结
The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of primary OA of the knee according to the ACR criteria, including radiologic evidence of OA
- •age >40 years
- •symptomatic disease for at least 6 months prior to enrollment
- •persistent pain despite receiving the maximum tolerated doses of conventional medical therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory drug (NSAID), with persistent pain defined as a minimum mean score of 25 mm on the visual analog scales (VAS) for global pain (0-100-mm range for each) daily pain during the month prior to study enrollment
- •ability to attend followup appointments
排除标准
- •secondary causes of OA
- •local or systemic infection
- •diabetes mellitus
- •systemic arthritis
- •allergy to anesthetic agent or contrast material
- •coagulopathy
- •anticoagulant therapy
- •had previous IA steroid injection
- •avascular necrosis of bone
- •patients who are on specific OA pharmacological therapy (NSAIDS, opioids) for more than 2 weeks prior enrollment
结局指标
主要结局
Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4
时间窗: baseline and 4 weeks
visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)
Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4
时间窗: baseline and 4 weeks
Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome.
次要结局
未报告次要终点
研究者
Gianfilippo Bagnato
Professore ordinario
University of Messina