High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis Among People Living in Hilly Terrain: A Randomized, Double Blind, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
A total of 80 patients with knee osteoarthritis (KOA) aged between fourty five and seventy years will be recruited by simple random sampling to participate in two group, randomized, double blind, controlled study. Recruited patients will be randomly divided in to two groups high intensity-laser therapy (HILT) group and ibuprofen gel phonophoresis (IGP) group. Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.The pain and quality of life will be assessed at the baseline and at the end of 8-week post-intervention period.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study
排除标准
- •Unwillingness to participate in the study
- •Recent history (within the last 3 months) of physical therapy to the same joint
- •Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
- •History of knee surgery/fracture
- •Acute synovitis/arthritis including the infectious conditions
- •Presence of malignancy
- •Pregnancy
- •Taking pain relief medications
结局指标
主要结局
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
时间窗: Changes will be measured at baseline, end of 8-week post-intervention period
The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be used to evaluate the disease-specific self-reported symptoms of OA. This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions).
Digitalized pain pressure algometer (ALGO-DS-01)
时间窗: Changes will be measured at baseline, end of 8-week post-intervention period
Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain, which is a reliable and valid tool
次要结局
- 36-Item Short Form Health Survey (SF-36)(Changes will be measured at baseline, end of 8-week post-intervention period)
研究者
Asir John Samuel
Associate Professor
Maharishi Markendeswar University (Deemed to be University)