Comparative Study Between Conventional Radiofrequency Ablation vs Chemical Neurolysis of Ganglion Impar for Treatment of Chronic Non Cancer Related Coccydynia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- pain relief using Numeric Pain score scale
研究概览
简要总结
Aim: compare effectiveness (satisfaction) and duration of pain relief between patients who perform the conventional thermal radiofrequency on the ganglion impar vs patients who perform the chemical neurolysis with alcohol in patients with non cancer coccydynia patients with non cancer coccydynia not responding to medical treatment will be divided into 2 groups before intervention , control group will receive conventional radiofrequency ablation of ganglion impar , while the study group will receive alcohol neurolysis
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non cancer coccydynia
- •Both genders
- •Age between 20-70 years.
- •ASA 1,2 & 3 physical status
- •xray coccyx lateral position showing normal joints and bones with no fractures
排除标准
- •Neurological disorders. (previous central and peripheral CNS affection).
- •coagulopathy INR > 1.8 or platelets < 50,
- •Infection at or near the injection site.
- •Presence of pacemaker or defibrillator.
- •known allergy to used medications.
- •patients with previous history of Radiotherapy, chemotherapy or metastasis
- •pregnant patients.
- •patients with rheumatological disorders (rheumatoid arthritis, diffuse idiopathic skeletal hyerostosis, psoriatic arthritis)
- •age <20 or >70
- •Xray coccyx showing fractures or abnormalities
研究组 & 干预措施
radiofrequency group
patients with non cancer coccydynia in this group will receive conventional radiofrequency on ganglion impar
干预措施: Radiofrequency ablation alone (Procedure)
alcohol neurolysis group
patients in this group will receive alcohol neurolysis on ganglion impar
干预措施: Alcohol injection (Procedure)
结局指标
主要结局
pain relief using Numeric Pain score scale
时间窗: 1 month
patients will be asked to describe their pain on Numeric pain scale ( an 11 numbers scale where 0 describes no pain and 10 describes the worst pain ) and compare it to before the procedure
pain relief of chronic non cancer coccydynia
时间窗: 6 months after the procedure
patients will be asked to describe their pain on Numeric pain scale and compare it to before the procedure
patient global impression of change (PGIC)
时间窗: 6 months
one-item questionnaire that asks patients to rate their overall improvement after a treatment.he scale typically includes ratings such as "very much improved," "much improved," "minimally improved," "unchanged," or "worse".
次要结局
未报告次要终点
研究者
Lydia edward aziz zakhary
lecturer of anesthesia , intensive care and pain management
Ain Shams University