Comparison of efficacy of perineural dextrose prolotherapy with perineural corticosteroid injection in the treatment of patients with occipital neuralgia in a tertiary care hospital in the Central India: A non-inferior, randomised, assessor blind, parallel arm study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pain reduction via VAS score and Barrow Neurological Pain Scale
研究概览
简要总结
According to International Classification of Headache Disorder, Occipital Neuralgia is described as Unilateral or bilateral paroxysmal, shooting or stabbing pain in the posterior part of the scalp, in the distribution(s) of the greater, lesser and/or third occipital nerves, sometimes accompanied by diminished sensation or dysesthesia in the affected area and commonly associated with tenderness over the involved nerve(s).
Occipital neuralgia typically affects the greater occipital nerve (GON) primarily, followed by the lesser occipital nerve (LON) and the third occipital nerve (TON). Currently, primary treatment for occipital neuralgia is an Occipital Nerve block with a local anaesthetic with or without corticosteroid that serve as a both diagnostic and therapeutic modality. While expert consensus supports the utilization of corticosteroids for peripheral nerve blocks, there are notable constraints to its application. For instance, it’s contraindicated in pregnancy and for patients with cosmetic concerns due to potential side effects like alopecia and cutaneous atrophy. As an alternative, we propose to study and compare the effect of perineural dextrose prolotherapy of GON/LON/TON as an alternative treatment for occipital neuralgia versus perineural steroid injection of GON/LON/TON on pain reduction and quality of life.
Yung-Tsan Wu, MD et al. compared the effects of corticosteroid and perineural injections of 5% dextrose around the median nerve in patients with carpal tunnel syndrome. The results showed that, at 4 to 6 months after injection, perineural injections of 5% dextrose were more beneficial than corticosteroid in patients with mild-to-moderate CTS, with a mean reduction of 4.3 VAS score in the dextrose arm and 1.7 in the steroid arm. This study aims to provide a comparison between perineural dextrose prolotherapy with perineural corticosteroid injection for treatment of occipital neuralgia.
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
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnose case of occipital neuralgia according to ICHD 3 criteria A Unilateral or bilateral pain fulfilling criteria B to E B Pain is located in the distribution of the greater, lesser, and/or third occipital nerves C Pain has two of the following three characteristics 1 Recurring in paroxysmal attacks lasting from a few seconds to minutes 2 Severe intensity 3 Shooting, stabbing, or sharp in quality D Pain is associated with both of the following 1 Dysaesthesia and/or allodynia apparent during innocuous stimulation of the scalp and/or hair 2 Either or both of the following a Tenderness over the affected nerve branches b Trigger points at the emergence of the greater occipital nerve or in the area of distribution of C2 E Pain is eased temporarily by local anesthetic block of the affected nerve F Not better accounted for by another ICHD 3 diagnosis.
排除标准
- •1 Pregnant females 2 Patients below the age of 18 and above 75 3 Patient with uncontrolled diabetes mellitus 4 Patient on analgesic medication for condition other than occipital neuralgia 5 Patients with neuralgia due to tumor, acute infection and/or trauma.
结局指标
主要结局
pain reduction via VAS score and Barrow Neurological Pain Scale
时间窗: 1) pre procedure | 2) 2 weeks post procedure | 3) 4 weeks post procedure | 4) 8 weeks post procedure
次要结局
- Difference in quality of life as measure by SF-12 scale(1) pre procedure)
- ii) To study the efficacy of perineural dextrose prolotherapy and perineural steroid injection in the treatment of patient with occipital neuralgia(1) pre procedure)
- To study the dermatomal distribution of occipital neuralgia in Greater Occipital Nerve, Lesser occipital Nerve and third occipital Nerve
- Document characteristic of background pain (quality, location, and intensity) and pain exacerbations (frequency, duration, quality) in occipital neuralgia
研究者
Dr Sonali Sahani
AIIMS, Nagpur