Complementary Treatment With Procaine Periarticular Injections for Pain Reduction and Functional Improvement in Elderly Individuals With Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Pain Levels
研究概览
简要总结
§ The goal of this clinical trial is to assess the effect of periarticular procaine injections combined with physical therapy on joint pain in individuals 65 and older suffering from osteoarthritis of the hip or the knee. The main question it aims to answer is: Is procaine effective in decreasing joint pain?
Researchers will compare procaine injections combined with physical therapy to physical therapy only to evaluate whether or not procaine helps decrease joint pain.
Participants will:
Undergo procaine periarticular injections and physical therapy Assess their symptoms and pain using scales and tests provided
详细描述
This clinical trial aims to evaluate the safety and efficacy of procaine complex injections in managing pain and improving functional capacity in elderly patients with osteoarthritis in the knee and/or hip. The study enrolled 178 patients aged 65 and older, who were randomly assigned to receive either physical therapy combined with periarticular procaine injections or physical therapy alone. Pain levels were assessed using the Visual Analogue Scale (VAS), and functional capacity was evaluated using the Lequesne Index, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), and other geriatric assessment tools. Results indicated significant pain reduction and functional improvement in the procaine group, highlighting a safe alternative treatment to surgery for older adults with osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 65 and older diagnosed with knee or hip osteoarthritis per the American College of Rheumatology criteria. Must exhibit radiographic evidence of OA and experience persistent joint pain
排除标准
- •Individuals with Alzheimer's, severe depression, cancer, or other severe health conditions, and those with allergies to procaine
研究组 & 干预措施
Experimental
Participants in the experimental arm received daily periarticular injections of procaine complex solution (5 ml containing 100 mg procaine hydrochloride) over a 10-day period. All injections were administered using sterile technique. Prior to treatment, sensitivity to procaine hydrochloride was assessed with a subcutaneous test dose (0.5 ml)
干预措施: Periarticular Procaine Injection (PAPI) (Drug)
Experimental
Participants in the experimental arm received daily periarticular injections of procaine complex solution (5 ml containing 100 mg procaine hydrochloride) over a 10-day period. All injections were administered using sterile technique. Prior to treatment, sensitivity to procaine hydrochloride was assessed with a subcutaneous test dose (0.5 ml)
干预措施: Kinesiotherapy (Other)
Control
Participants received only physical therapy without procaine injections.
干预措施: Kinesiotherapy (Other)
结局指标
主要结局
Pain Levels
时间窗: Baseline to Day 10
Change in Pain Level on Visual Analogue Scale (VAS)
次要结局
- Functional Improvement(Baseline to Day 10)
- ADL and IADL Scores(Baseline to Day 10)
- Geriatric Depression Scale(Baseline to Day 10)