Comparison of Ganglion Impar Block With Physical Therapy Versus Caudal Epidural Steroid Injection With Physical Therapy for Patients With Coccydynia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The study aims to evaluate the efficacy of two treatment modalities for patients suffering from coccydynia: Ganglion Impar Block (GIB) combined with physical therapy, and Caudal Epidural Steroid Injection (CESI) also accompanied by physical therapy. Coccydynia, characterized by pain in the coccygeal region, can significantly impair daily functioning and quality of life.
详细描述
Participants were assessed using various outcome measures, including the SF-12, Oswestry Disability Index (ODI), and Numeric Pain Rating Scale (NPRS). Data collection will occur at baseline and through four follow-up points over 16 weeks, allowing for a comprehensive evaluation of both immediate and long-term treatment effects. By comparing these two interventions, the study seeks to determine which approach yields superior results in alleviating pain and improving functional outcomes for patients with coccydynia, thereby contributing valuable insights into the management of this condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited.
- •Participants who will be willing & able to adhere to the study protocol.
- •Including participants who will be attending follow-up appointments & completing outcome measures.
- •Participants who will be able to understand & provide written informed consent.
- •Participants with a complete screening of other medical conditions and previous medical records.
排除标准
- •Participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (GIB or CESI) was omitted.
- •Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
- •Participants with neurological conditions affecting pain perception or sensation were excluded.
- •Participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.
研究组 & 干预措施
Interventional group I
干预措施: Interventional group I (Diagnostic Test)
Interventional group II
干预措施: Interventional group II (Combination Product)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: 12 Months
Used as the primary outcome measure. Participants will rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. This measure will assess changes in pain levels from baseline through various follow-up points.
Oswestry Disability Index (ODI)
时间窗: 12 months
The Oswestry Disability Index will serve as the secondary outcome measure. This questionnaire evaluates the degree of disability experienced by participants due to their pain, focusing on various aspects of daily living and functional capacity. Additionally, the SF-12 health survey will be used to measure the overall health-related quality of life, providing further insights into the impact of the interventions.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University