NCT07715188招募中不适用
A Prospective Study of Low Dose Radiotherapy for Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF
研究概览
简要总结
This single institution, multi-site, single arm prospective study will enroll patients with a history of OA and assess changes in pain and function after treatment with LDRT as measured by patient-reported outcomes.
详细描述
To evaluate the use of select instruments (BPI-SF, LEFS, UEFI, PROMIS Global) to detect changes in pain, function, and well-being in patients with OA who are refractory to or otherwise unable to receive other standard of care therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Diagnosis of OA >3 months in hips, knees, hands, shoulders, ankles or elbows.
- •Refractory to standard of care therapies for OA or those who are being considered for more aggressive interventional treatment such as joint replacement, but more conservative treatment is desired.
- •Provision of signed and dated informed consent.
排除标准
- •Unable to reasonably complete study instruments.
结局指标
主要结局
To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF
时间窗: Within 1 year
Assess the degree of patient-reported pain prior to and after use of 1-2 courses of LDRT
次要结局
- To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF(at ~ 3 months)
- To measure change in PROMIS scores(From baseline at 3-month and 1-year follow-up)
- To measure change in LEFS scores as measured(From baseline at 3-month and 1-year follow-up)
- To measure change in UEFI scores as measured(From baseline at 3-month and 1-year follow-up)
研究者
研究点 (2)
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