Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Patients Suffering From Knee Arthritis; A Single-arm Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Visual analogue scale(VAS)
研究概览
简要总结
The goal of this clinical trial is to test low-intensity continuous ultrasound stimulator(LICUS) for patients suffering from knee arthritis. it aims to evaluate the pain relief effect of LICUS.
35 participants were recruited, treated by LICUS on the knee joint for 5 minutes, 3 times a day for 4 weeks.
This study has single group and is for a before and after comparison of clinical treatment.
详细描述
Subject: 35 osteoarthritis patients Evaluation measure: Visual Analogue Scale (VAS), McMaster Universities Osteoarthritis Index (WOMAC) Method: A total of 35 subjects were selected in consideration of the dropout rate of 20%. Selected subjects were treated as a single group without randomization, and an appropriate amount of gel was applied to the knee OA pain area for 4 weeks. A blinded evaluation at baseline and after treat-ment was made. Primary outcome was pain on movement assessed by the VAS index. Secondary outcomes consisted of the WOMAC scores.
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
盲法说明
No need of blinding
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 40 to 60 years with pain due to OA of the knee and able to walk voluntarily
- •Those who have more than one osteophyte in the tibiofemoral joint on radiographic findings (Kellgren-Lawrence gradesⅡ,Ⅲ)
- •At visit 1 (screening) and visit 2, the pain status during knee OA activity was 100 mm pain VAS, as a result, those who are over 40mm
- •If the Kellgren & Lawrence Grades are the same, target the one with the higher 100mm pain VAS
- •Patients who are willing or able to follow the doctor's instructions, including joint movements
- •Persons who can comply with concomitantly permitted drugs, prohibited drugs, and relief drugs
- •Persons who can maintain the same exercise and activity during the clinical trial period
- •Fully understand the purpose and procedure of this clinical trial
排除标准
- •Those who have a history of rheumatoid arthritis or gouty arthritis or who have peripheral pain other than the knee joint patient.
- •Those with fractures or dislocations on simple radiological examination.
- •Those who are identified, or those with a similar risk of neuromuscular disease
- •Those who have participated in other clinical trials within 6 months of participating in clinical trials.
- •Patients with severe pain in the knee joint other than angular deformity, instability, and index knee in the knee joint
- •Patients with other tumors other than degenerative knee arthrosis
- •Persons with systemic symptoms that may affect knee pain
- •Pregnant and lactating women
结局指标
主要结局
Visual analogue scale(VAS)
时间窗: 4 weeks
Evaluation of pain on movement assessed by the VAS index
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(4 weeks)
研究者
Kyu Jae Lee
Professor
Wonju Severance Christian Hospital