Effectiveness of Perforating Cutaneous Nerve Injection in Patients With Chronic Coccydynia: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Effectiveness of Perforating Cutaneous Nerve Injection
研究概览
简要总结
Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years.
- •Chronic coccyx pain (≥3 months).
- •Pain Visual Analogue Scale (VAS) score ≥
- •Pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion).
排除标准
- •Injection to the area in the last 3 months.
- •Concurrent mechanical or inflammatory low back pain.
- •Coccyx pain that started during pregnancy or postpartum.
- •History of myelomeningocele or spina bifida.
- •History of sacrococcygeal luxation or subluxation (confirmed by radiography).
- •History of coccyx fracture.
- •Concurrent neurological deficit.
- •Skin disease affecting the injection area.
- •History of malignancy.
- •Pregnancy or breastfeeding.
- •Severe coagulopathy.
- •Infection at the injection site.
- •Neurological or psychiatric diseases, including ongoing depression (Beck Depression Inventory Score >14).
研究组 & 干预措施
%5 Dextrose Injection Group
Participants in this arm will receive an ultrasound-guided injection of 5% dextrose solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve. The intervention aims to alleviate symptoms of chronic coccydynia by reducing nerve entrapment. Participants will continue their existing physical therapy/medical treatment regimen throughout the study.
干预措施: US Guided Perineural Injection and Neuroprolotherapy (Procedure)
Placebo Injection Group
Participants in this arm will receive an ultrasound-guided injection of a placebo solution (saline) into the same anatomical region as the experimental group. This arm serves as a control to evaluate the efficacy of the dextrose injection in treating chronic coccydynia symptoms. Participants will continue their existing physical therapy/medical treatment regimen throughout the study.
干预措施: US Guided Perineural Injection and Neuroprolotherapy (Procedure)
结局指标
主要结局
Effectiveness of Perforating Cutaneous Nerve Injection
时间窗: Baseline, 2 weeks, 1 month, and 3 months post-treatment
To evaluate the effectiveness of perforating cutaneous nerve injection in reducing pain in patients with chronic coccydynia. Pain levels will be assessed using the Visual Analogue Scale (VAS) during sitting, movement and rest.
次要结局
- Change in Pressure Pain Threshold(Baseline, 2 weeks, 1 month, and 3 months post-treatment)
- Change in Quality of Life(Baseline, 2 weeks, 1 month, and 3 months post-treatment)
研究者
Enes Efe Is
MD
Sisli Hamidiye Etfal Training and Research Hospital