A Multi-center, Randomized, Single-blinded, Exploratory Clinical Trial to Evaluate Safety and Efficacy of Alleviating Symptom of Low-dose RaDiation Therapy in Patients With KNee osteoArthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- OMERACT-OARSI response rate
研究概览
简要总结
Clinical verification of knee osteoarthritis pain relief and functional improvement using low-dose radiation therapy
详细描述
This clinical trial is a multicenter, randomized, single-blinded, exploratory clinical trial to evaluate the efficacy and safety of low-dose radiation for knee osteoarthritis patients. The experimental group is treated with low-dose irradiation 6 times for 3 weeks according to the dose determined for each group, and the control group is treated with sham irradiation. Both the experimental group and the control group visit the hospital 4 weeks after irradiation and at 4, 8, and 12 months to evaluate the efficacy and safety.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-85 years old
- •Kellgren-Lawrence grade 2-3 and diagnosed as a patient with primary knee osteoarthritis according to the ACR knee OA diagnostic criteria
- •Patients with VAS 40 or higher when walking, with or without medication at the time of screening
- •Patients who have VAS 50 or more and 90 or less when walking at the baseline
- •Among patients who were previously taking analgesic drugs at the time of screening, those with an increase in pain of 10 points or more at the baseline
- •Patients who do not want to take non-narcotic analgesics, those who have failed to control their pain due to the use of non-narcotic analgesics, or candidates for invasive treatment (intra-articular injection, arthroplasty, etc.)
- •A person who has a will to discontinue all pain medications except for rescue medications throughout screening, baseline, and clinical trials related to knee arthritis
- •A person who gives consent to use an approved contraceptive method from screening to 3 months after the end of the clinical trial
- •A person who understands the eligibility requirements for the study and has signed the consent form
排除标准
- •A history of knee irradiation in the past
- •Patients participating in other degenerative arthritis clinical trials
- •Kellgren-Lawrence grade 4
- •A history of malignancy within the last 5 years
- •A history of knee or hip surgery in the past
- •Patients who have received systemic steroid treatment or intra-articular steroid/hyaluronic acid injection within 2 months of screening
- •Patients with hip degenerative arthritis or other diseases of NRS 5 or higher that may affect functional score evaluation
- •Patients who are scheduled for surgical treatment of the knee joint during the clinical trial period
- •BMI > 39 kg/m2
- •Known history of analgesic or substance abuse within 2 years of screening
- •History, diagnostic signs or symptoms of any of the following clinically significant psychiatric disorders that would render the study ineligible (psychotic disorder, depression, somatic disorder)
- •History, diagnostic signs, or symptoms of any of the following clinically significant heart diseases that would render the study ineligible (surgery or stenting for ischemic heart disease and coronary artery disease within 6 months prior to screening)
- •History of other diseases that may affect the index joint, including autoimmune diseases (lupus, rheumatoid arthritis, etc.)
- •Fibromyalgia history or diagnosis
- •If the researcher judges that a person with significant trauma or other findings considered clinically important is inappropriate for participation in this study
研究组 & 干预措施
sham radiation therapy
sham radiation therapy
干预措施: sham radiation therapy (Radiation)
low-dose radiation therapy, 30 cGy/6 fx (experimental 1)
low-dose radiation therapy, 30 cGy/6 fx
干预措施: low-dose radiation therapy (Radiation)
low-dose radiation therapy, 300 cGy/6 fx (experimental 2)
low-dose radiation therapy, 300 cGy/6 fx
干预措施: low-dose radiation therapy (Radiation)
结局指标
主要结局
OMERACT-OARSI response rate
时间窗: 4 months
OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) response rate at 4 months. The OMERACT-OARSI criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.
次要结局
- Changes in serum ESR (Erythrocyte sedimentation rate)(4 weeks, 4 months, 8 months, 12 months)
- Changes in pain score(4 weeks, 4 months, 8 months, 12 months)
- Changes in global assessment(4 weeks, 4 months, 8 months, 12 months)
- Radiological Changes Evaluated by Knee X-ray(12 months)
- Radiological Changes Evaluated by Knee MRI(4 months, 12 months)
- OMERACT-OARSI response rate(4 weeks, 8 months, 12 months)
- Changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score(4 weeks, 4 months, 8 months, 12 months)
- Change in the amount of analgesic rescue medication usage(4 weeks, 4 months)
- Changes in serum CRP (C-reactive protein)(4 weeks, 4 months, 8 months, 12 months)
研究者
Byoung Hyuck Kim
Prof. Dr.
Seoul National University Hospital