Evaluate the effect of cold knee pack on pain pressure threshold and range of motion in knee osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Pressure Threshold (PPT) will be measured by using an Algometer at the medial aspect of the patient’s affected knee
研究概览
简要总结
Osteoarthritis (OA) is a chronic, progressive joint disorder characterized by cartilage degeneration, pain, stiffness, and functional limitations, predominantly affecting weight-bearing joints such as the knees. It is influenced by factors like aging, obesity, joint trauma, and repetitive use, with knee OA being particularly prevalent among the elderly and women. Cold therapy, especially cold knee packs, offers a non-invasive treatment option with physiological effects, including reduced nerve conductivity, inflammation, and pain, as well as improved pain thresholds and joint mobility. However, despite its widespread use, there is limited scientific evidence quantifying its benefits. This study aims to address this gap through a randomized controlled trial involving 60 participants aged 40–75 years with knee OA. The study group will receive yoga and naturopathy interventions combined with a cold knee pack, while the control group will receive only yoga and naturopathy. Pain Pressure Threshold (PPT), assessed with a Biotronix Digital Pressure Algometer, will serve as the primary outcome, while pain intensity and Range of Motion (ROM), evaluated using the Visual Analogue Scale (VAS) and a goniometer, respectively, will be secondary outcomes. Statistical analysis will determine the efficacy of cold knee packs in improving PPT, pain, and ROM in individuals with knee OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Experiencing mild to moderate knee pain.
- •Able to provide informed consent.
排除标准
- •Recent knee surgery within six months, Use of other treatments for knee osteoarthritis during the study period, Conditions contraindicating cold therapy, Presence of open wounds, skin infections, or dermatological conditions on the knee, Neurological disorders affecting sensory perception, Rheumatoid arthritis and Gouty arthritis.
结局指标
主要结局
Pain Pressure Threshold (PPT) will be measured by using an Algometer at the medial aspect of the patient’s affected knee
时间窗: baseline and after three weeks
次要结局
- Pain and Range of Motion (ROM) in knee osteoarthritis using a Visual analogue scale (VAS), and Goniometer before and after the intervention(Baseline and after three weeks)
研究者
Narmatha M
International Institute of Yoga and Naturopathy Medical Sciences
