Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 主要终点
- Digitalized pain pressure algometer
研究概览
简要总结
Patients affected with osteoarthritis knee have associated with pain and inflammation of the joint capsule, impaired muscular stabilization, decrease range of motion and functional disability. Laser therapy, phonophoresis, transcranial direct current stimulation (tDCS) and conventional physiotherapy exercises has innumerable benefits to the patients with knee osteoarthritis (KOA).However, it is still not clear which treatment is effective among them in rehabilitating the patients with chronic knee osteoarthritis (KOA). Aim is to establish the benefits of High intensity Laser therapy, phonophoresis, tDCS and conventional physiotherapy in the treatment of patient with chronic KOA living in the hilly terrain. A total of 160 patients with chronic KOA will be recruited by the simple random sampling (random number generator) to participate in randomized, double blind randomized controlled, study. Recruited patients with chronic KOA will be randomly divided into four groups, high intensity-laser therapy (HILT) group, ibuprofen gel phonophoresis (IGP) group, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group. Duration of the treatment will be 8 minutes in one session/knee joint for HILT and IGP and 30 minutes in one session for tDCS each day for 3 days/week for 8 weeks. Thus, each patient with chronic KOA will receive 24 sessions in total. The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC), Digitalized pain pressure algometer (ALGO-DS-01) and 36-Item Short Form Health Survey (SF-36) questionnaire are the outcome measures will be recorded at baseline, 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 chronic knee OA according to the diagnostic criteria of American College of Rheumatology (ACR) were included in the study
- •Age between 45-70
- •Both sex male and female
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
- •Any metal implants near the site of stimulation
结局指标
主要结局
Digitalized pain pressure algometer
时间窗: Changes will be measured at baseline and end of 8 week intervention
Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA. Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain for Mechanical sacroiliac joint dysfunction, which is a reliable and valid tool for assessing sacroiliac joint dysfunction. The inter rater reliability of pressure pain algometer was demonstrated to be moderate to good reliability with interclass correlation coefficient (ICC) of (0.62-0.84)
Western Ontario and Mc Master Universities Osteoarthritis Index
时间窗: Changes will be measured at baseline and end of 8 week intervention
The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be was used to evaluate the disease-specific self-reported symptoms of OA.48 This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions). These 24 items are presented in a five-point Likert (0-4) scale, where higher scores indicate the higher intensity of the related symptom. The minimal clinical important difference of WOMAC at 2 month of intervention is found to be, 14.1 The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
次要结局
- 36-Item Short Form Health Survey(Changes will be measured at baseline and end of 8 week intervention)
研究者
Asir John Samuel
Associate Professor
Maharishi Markendeswar University (Deemed to be University)