The Effect of Low Intensity Ultrasound Therapy on Chronic Pain Due to Osteoarthritis of the Knee.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Pain Intensity Measure
研究概览
简要总结
To evaluate a new, low intensity ultrasound device in the treatment of chronic pain due to osteoarthritis in the knee.
Enhancing CBD oil penetration into joints by sonophoresis.
详细描述
Materials and Methods:
Inclusion criteria:
- Osteo-arthritis of knee joint diagnosed through X-Ray evaluation
- Moderate or sever level of pain due to knee osteoarthritis and no other known reason
- Male of Female patients of 18 to 85 years old
- Pain interfering with activities of daily life
Exclusion criteria:
- Cancer pain or any other concurrent cancerous condition
- History of Knee replacement surgery in the study joint
- Local infection or any kind of inflammatory or allergic skin lesion
- Rheumatoid arthritis
- Mobility disorders or not being able to walk
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, Care Provider, Investigator)
盲法说明
A Study Administrator will assign subjects to a treatment group randomly, and keep this information strictly confidential. Subjects and investigators will be blinded. The Study Administrator will assign each participant a randomly generated Patient ID number to be used in the collection of data.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteo-arthritis of knee joint diagnosed through X-Ray evaluation
- •Moderate or sever level of pain due to knee osteoarthritis and no other known reason
- •Male of Female patients of 18 to 85 years old
- •Pain interfering with activities of daily life
排除标准
- •Cancer pain or any other concurrent cancerous condition
- •History of Knee replacement surgery in the study joint
- •Local infection or any kind of inflammatory or allergic skin lesion
- •Rheumatoid arthritis
- •Mobility disorders or not being able to walk
研究组 & 干预措施
Group A
The first patient group will receive Low Intensity Ultrasound Therapy on the affected knee joint, using the CPI-LIPUS Device
干预措施: Low Intensity Ultrasound Therapy (Procedure)
Group B
Will be "treated" with an identical device whose ultrasound emitting capabilities has been nullified. This device appears to operate, including illumination of the operating light.
干预措施: Low Intensity Ultrasound Therapy (Procedure)
Group B1
The first patient group will receive high CBD oil applied topically to the affected knee joint.
干预措施: Enhancing CBD oil penetration into joints by sonophresis (Other)
Group B2
This group of patients will not receive high CBD oil to the affected joint.
结局指标
主要结局
Pain Intensity Measure
时间窗: The outcome will be measured over a period of 6 weeks.
Participants who receive treatment using the CPI-LIPUS , a low intensity pulsed ultrasonic device will document any changes to their pain severity on a Brief Pain Inventory numeric scale from 1 to 10, with 1 being no pain, and 10 being the worst pain at each appointment.
次要结局
未报告次要终点
研究者
Dr. Kevin Rod
Director
Toronto Poly Clinic