A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Percentage of participants with tingling
研究概览
简要总结
To compare the effects of low intensity pulsed ultrasound with high intensity continuous ultrasound in knee osteoarthritis
详细描述
Knee osteoarthritis is a common disorder affecting elderly and obese. Currently, there are 3 types of treatment; pharmacological, non-pharmacological and surgery. Though ultrasound, a non-pharmacological treatment, is increasingly used in knee osteoarthritis, the advantages and disadvantages of low intensity pulsed ultrasound (LIPUS) and high intensity continuous ultrasound (HICUS) are yet to be clarified. Therefore, a randomized control trial will be done to compare LIPUS and HICUS in participants with knee osteoarthritis presenting to Department of Physical Medicine and Rehabilitation, Yangon General Hospital, Myanmar.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with knee pain (VAS 3 to 6)
- •Kellgren and Lawrence grade 2 and 3 in X' ray knee joint
排除标准
- •Rheumatoid arthritis, Gouty arthritis, Spondyloarthropathies, Metabolic arthropathies
- •Infection of knee joint
- •Tumor of knee joint
- •History of hypersensitivity to heat
- •Previous knee surgery in affected side
- •Intra-articular injection within previous 3 months
- •Participants taking treatment with other physical modalities such as low-level laser therapy and Trans Cutaneous Electrical Nerve Stimulation
结局指标
主要结局
Percentage of participants with tingling
时间窗: 8 weeks
Tingling sensation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Visual Analog Scale (VAS)
时间窗: 8 weeks
It is one of the most commonly used measures of pain intensity and it is divided into 10 ordinal ratings with 0 being "no pain" and 10 being "pain as bad as it could be".
Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC)
时间窗: 8 weeks
This index measures clinically important symptoms of pain, stiffness and function. It consists of 23 questions (5 pain, 2 stiffness and 16 physical function) and the maximum score is 100, indicating the worst outcome while the minimum score is 0, indicating the best outcome.
Percentage of participants with skin irritation
时间窗: 8 weeks
Skin irritation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with oedema
时间窗: 8 weeks
Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with burns
时间窗: 8 weeks
Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
次要结局
未报告次要终点
研究者
Wunn Lei Thwe
Principal Investigator
Ministry of Health and Sports, Myanmar