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临床试验/NCT06458179
NCT06458179已完成不适用

Retrospective Cohort Study for One Year Follow-up: Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve is Effective

Mersin Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
NRS

研究概览

简要总结

The International Headache Society (IHS) defines occipital neuralgia, as a unilateral or bilateral paroxysmal, shooting, or stabbing pain in the posterior region of the scalp, in the distribution of the greater occipital nerve (GON), lesser occipital nerve (LON), or third occipital nerve (TON). The condition is occasionally accompanied by diminished sensation or dysesthesia in the affected area and is frequently associated with tenderness over the involved nerves. The majority of cases with occipital neuralgia are idiopathic, with no clearly defined anatomical cause. First, conservative treatment approaches including medication and physical therapy are frequently used. When conservative measures fail to alleviate occipital neuralgia, interventional treatments such as local occipital nerve anesthetic and corticosteroid infiltration, botulinum toxin A injection, occipital nerve subcutaneous neurostimulation or occipital nerve radifrequency treatment may be used.

详细描述

Radiofrequency ablation (RFA) is a thermal ablative procedure commonly used to treat chronic neurogenic pain by targeting peripheral nerves or dorsal root ganglion by destructing the tissue at a temperature ranging beteen 60-80 C. The pain is interrupted by destructing the nerve with Wallerian dejeneration. The pain interruption period is longer and stronger than pulsed radiofrequency. GON is a pure sensory nerve, RFA may be an alternative therapy option for occipital neuralgia. By ultrasound (US) guidance, at C2 level , GON lies between semispinalis capitis muscle and inferior oblique muscle. The GON is well identified here and can be easily targeted rather than trying to identify the terminal subcutaneous branches at the nuchal line. Diagnostic blockade was administered to patients who did not respond to conventional therapy. If the response to diagnostic blockade was greater than 50%, RFA was instituted one week later. Patients' headache intensity was measured using the Numeric Rating Scale-11 Pain Score (NRS) at each appointment (pre-intervention, 1-3-6, and 12 months post-intervention). At each appointment, an evaluation of headache disability was conducted using the Headache Impact Test (Hit-6) and the number of headache days per month. The efficacy of the treatment was defined as NRS<4 at the twelveth month. During the initial evaluation, patients' demographic details and headache symptoms were thoroughly questioned. In accordance with the Turkish National Headache and Pain Research Association's recommendation, patients were asked to keep up headache diaries for the duration of the treatment and all subsequent appointments. The headache intensity, headache disability and the number of headache days in a month, as well as the use of rescue medication, including NSAIDs and paracethamol, were determined from the diaries and discussed with the patient at each session.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral primary occipital neuralgia

排除标准

  • Patients lacking documentation or inadequate follow-up
  • Patients whom taking analgesic medication during the follow-up period
  • Bilateral occipital neuralgia
  • Secondary occipital neuralgia (e.g., cervical radiculopathy, infection, tumor, vascular compression of nerve, musculoskeletal diseases like C1-2 arthrosis)
  • Other primary headaches
  • Dermatitis or skin infections
  • Pacemaker

结局指标

主要结局

NRS

时间窗: Change from Baseline VAS at 1,3, 6 and 12 months

Numerical rating scale (NRS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

次要结局

  • Headache impact disability index (HIT-6)(Change from Baseline VAS at 1,3, 6 and 12 months)

研究者

发起方
Mersin Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Suna Aşkın Turan

sponspor investigator

Mersin Training and Research Hospital

研究点 (1)

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