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
概览
- 阶段
- 不适用
- 干预措施
- sham radiation therapy
- 疾病 / 适应症
- Knee Osteoarthritis
- 发起方
- Seoul National University Hospital
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- OMERACT-OARSI response rate
- 状态
- 已完成
- 最后更新
- 5天前
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.
研究者
Byoung Hyuck Kim
Prof. Dr.
Seoul National University Hospital
入排标准
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
研究组 & 干预措施
sham radiation therapy
sham radiation therapy
干预措施: sham radiation therapy
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
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
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)