Patient Reported Outcomes Following Interventional Procedures in Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Pain score
研究概览
简要总结
The investigators aim from this study, to determine the safety and efficacy of pulsed radiofrequency in the management of pudendal neuralgia, compared to current a standard intervention, which is corticosteroid injection for PN, as part of multidisciplinary pain management.
详细描述
The aim of this study is toillustrate whether pulsed radiofrequency treatment is safe and effective intreating the chronic perineal pain associated with PN or pudendal nerve compression; and whether it can be used as an integral part of its multidisciplinary managementBased on literature, the prevalence of Chronic Pelvic Pain (CPP) in general population ranges between 5.7% and 26.6%(Ahangari, 2014). There are many countries and regions with no published data in the field of CPP (Ahangari, 2014). CPP is a great burden to the patients and the healthcare systems (Latthe et al., 2006). About £154 million was the estimated cost of treatment for the women who suffer from CPP per year (Cheong and William Stones, 2006). CPP affects one's movement and their posture due to the secondary hyperalgesia in the pelvic muscles leading to diminished proprioception. About 50%- 70% of women with CPP have limitation on their daily activity(Ahangari, 2014). PN occurs in men, but the incidence/prevalence is not well studied. The principle therapy for chronic neuropathic pain is to eliminate the underlying causes of the pain (Belgrade, 2003), for PN this may involve surgical decompression. Pharmacotherapy and physiotherapy are two different options for treatment of neuropathic pain but they each come with limitations and drawbacks. Different techniques for pudendal nerve block have been described for managing PN but they have complications that may be serious such, vascular injury or intravascular injection with toxicity. The indication of surgery is in patients with failure of conservative treatment or other PNB techniques / modalities and includes decompression or neuromodulation.
Type of the study: A retrospective randomized controlled study Study Setting: University college London hospital
Sample Size Calculation:
Sample size calculation was carried out using G*Power 3 software (Faul et al., 2007). A calculated minimum sample of the cases is 60 patients, 30 in each group.
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...):
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic pain> 6 months
- •Patients aged > 18years
- •Patients with unilateral or bilateral regional pelvic pain withpudendal irritation diagnosed by a pain clinician and clinically indicated to undergo pudendal nerve block by a consultant experienced in the field.
排除标准
- •Known concurrent neurological or neurodegenerative disease, including those with impaired neurotransmission e.g. myasthenia gravis, multiple sclerosis, spinal cord injury etc
- •Pelvic surgery is expected within 3 months
- •Breastfeeding or pregnant women
- •Known current pelvic/pelvic organ infection or malignancy (Red flags)
- •Concurrent radiotherapy treatment to pelvis
- •Allergy/sensitivity to lidocaine anaesthetic or/ and corticosteroids therapy
- •Contraindication to receive a Pudendal nerve block eg high risk of bleeding
- •Active psychiatric or mental conditions ▪ Other uncontrolled medical condition
研究组 & 干预措施
Injection
Injection of local anesthetic and steroid to the diseased nerve
干预措施: Injection (Drug)
Radiofrequency
Application of radiofrequency to the diseased nerve
干预措施: Radiofrequency (Device)
结局指标
主要结局
Pain score
时间窗: 6months 1 year after intervention
Pain score value from 1 to 10 reported by each individual patient following inter vention
次要结局
未报告次要终点
研究者
Medhat Farghaly
Assistant lecturer of anesthesia , Intensive care and pain medicine
Assiut University