CTRI/2024/11/076610招募中2 期
A Prospective Single arm Study to assess the Efficay of Low Dose Radiation Therapy for Control of symptoms in Elderly patients suffering from Osteoartharitis.
AMIYA GOPAL RANJA1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年11月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- pain Relief by VAS
研究概览
简要总结
Patients with High Grade osteoarthritis with significant pain even after conventional treatment and Physical therapy will be included in the study. Patients will receive Radiotherapy 3 Gy in 6 fractions two times a week. Patients will be assessed by Visual Analogue scale (VAS) at planned interval. Change in pain score would be the primary outcome while change in radiological disease status will be the secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 50 years or more
- •OA of any joint with pain, disability or deterioration of Quality of life not adequately controlled with exercise, tropical analgesics and single NSAIDS.
- •Kellgren – Lawrence grade 3 patients and grade 4 patients if they are not candidate for joint replacement due to concurrent morbidity making them unfit for surgery or has refused surgery due to any reason.
- •Patients who has inadequate pain control on analgesics currently on.
- •A person who understands the eligibility requirements for the study and has signed the consent form.
排除标准
- •1.History of affected joints irradiation in the past.
- •2.Patient participating in other degenerative arthritis clinical trials 3.Kellgren- Lawrence grade 4 except for those included due to non- feasibility of surgery.
- •History of malignancy within the last 5 years.
- •Uncontrolled comorbid conditions.
- •History of collagen vascular diseases.
- •Patients who are scheduled for surgical treatment of that joint during the clinical trial.
- •BMI more than 39Kg/m
- •Known history of analgesic or substance abuse within 2 years of screening.
- •Patient having any psychiatric disease.
- •Fibromyalgia history or diagnosis.
结局指标
主要结局
pain Relief by VAS
时间窗: 4weeks,4 months,8 months and 12 months
次要结局
- change in radiological status of OA(4 months, and 12 months)
研究者
AMIYA GOPAL RANJA
IPGMER AND SSKM HOSPITAL
研究点 (1)
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