Effectiveness of fluoroscopy-guided pulsed radiofrequency ablation in comparison with local anaesthetic and steroid block of ganglion impar in improving pain and functions in patients with coccydynia: a randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
研究概览
简要总结
Coccydynia is a chronic pain condition affecting the coccyx, leading to significant discomfort, functional impairment, and reduced quality of life. Diagnosis is based on proper history, clinical evaluation and imaging findings. The primary goal of treatment is to relieve pain, improve function and enhance quality of life while minimising side effects. Pulsed radiofrequency ablation of the ganglion impar has emerged as a promising treatment for chronic coccydynia due to its ability to provide long lasting relief with minimal complications. However, its efficacy compared to conventional ganglion impar block remains an area of active research. The objective is to determine the effectiveness of fluoroscopy-guided pulsed radiofrequency ablation of the ganglion impar in comparison to local anaesthetic and steroid block of the ganglion impar in improving pain and functions in patients with coccydynia. This study, a single-blinded randomized controlled trial, will be conducted in the Department of Physical Medicine and Rehabilitation, RIMS, Imphal. A total of 28 patients with coccydynia attending the PMR OPD will be selected and randomized into two groups. Outcomes will be assessed using the Numeric pain rating scale (NPRS) and Oswestry Disability Index (ODI) at baseline and postintervention at 1st, 4th, 12th and 24th weeks. Statistical analysis will include chi-square test, independent t-test, and repeated measures ANOVA, with a p-value <0.05 considered statistically significant. Ethical approval will be taken from the Research Ethics Board, RIMS, Imphal, for this clinical study and will be registered in the Clinical Trials Registry of India (CTRI). All the participants will be informed about the nature of the study, and willing participants will be asked to sign the informed written consent form. Privacy and confidentiality of participants will be maintained by identifying the patients using MRD numbers, and they will be informed that they can withdraw from the study at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are aged between 20 years to 60 years, has coccydynia who has not had relief of symptoms even after 6 months of conservative treatment, has NPRS more than or equal to 4, functional impairment (ODI more than 20%), has positive diagnostic block( more than 50% improvement in pain).
排除标准
- •Patients who are pregnant, has history of injection with steroids in and around coccyx in the last 3 months, cognitive impairment, prior history of coccygectomy or pelvic surgery, cardiac pacemaker, uncontrolled diabetes and hypertension systemic diseases, coagulation disorder, has local infections, has allergy to anaesthetic medication and steroid used, and who has tumors of the pelvic region.
研究者
Dr Rahul Ch Marak
RIMS Imphal Manipur