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Набор скоро начнётся NCT07363083

Treatment Response to GON Pulsed Radiofrequency in Elderly Patients With Chronic Migraine

Наблюдательное Headache, Migraine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Headache, Migraine. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Predictors of Treatment Response to Greater Occipital Nerve Pulsed Radiofrequency in Older Patients With Chronic Migraine

Обзор

Headache disorders are highly prevalent in older adults, yet their management remains challenging due to comorbidities, polypharmacy, and the paucity of evidence derived from geriatric populations. Most randomized clinical trials exclude elderly patients, underscoring the need for effective and safe non-pharmacological treatment strategies for headache in this age group. Greater occipital nerve blocks are commonly used in the treatment of migraine and other headache disorders; however, their clinical benefit is often transient. Pulsed radiofrequency (PRF) has been introduced as a minimally invasive technique aimed at prolonging therapeutic effects through neuromodulation without causing structural neural damage. Although greater occipital nerve pulsed radiofrequency (GON-PRF) has demonstrated efficacy in various headache disorders, its effectiveness in patients aged 65 years and older has not been adequately investigated. The primary aim of this study is to evaluate the effectiveness of GON-PRF in patients aged ≥65 years with chronic migraine by assessing changes in pain intensity, monthly headache days, and monthly severe headache days. The secondary aim is to identify geriatric predictors of treatment response, including frailty status and the Geriatric Nutritional Risk Index (GNRI), in order to support individualized treatment strategies for older adults.

Подробное описание

Headache disorders are common across all age groups. As the global population ages, the number of older adults affected by headache disorders continues to rise, and an increasing proportion of elderly individuals seek medical care for headache-related complaints. Although primary headache disorders remain prevalent in this population, secondary causes must always be excluded as a first step. Previous estimates suggest that the one-year prevalence of primary headache disorders in adults aged 55-94 years is approximately 40.5% (1).

The management of headache in geriatric patients is often complex and challenging, requiring careful consideration of multiple factors, including comorbidities, polypharmacy, potential drug interactions, and age-related adverse effects. Moreover, evidence guiding headache treatment in older adults is limited, as most published clinical trials have excluded elderly populations. Consequently, there is a clear need for effective treatment options for headache in older adults, particularly non-pharmacological approaches that are less influenced by comorbid conditions and medication burden.

Peripheral nerve blocks, particularly greater occipital nerve blocks (GONB), have long been used in the treatment of various headache disorders and cranial neuralgias, including migraine, cluster headache, and cervicogenic headache, and may represent a safe alternative to standard pharmacotherapy in this demographic. In a retrospective study by Hascalovici et al., which evaluated the demographic, clinical, and therapeutic characteristics of patients aged 65 years and older treated with peripheral nerve blocks (greater and/or lesser occipital, auriculotemporal, supraorbital, and supratrochlear nerves), peripheral nerve blocks were reported to be a safe and effective headache management strategy for older adults (2).

Although greater occipital nerve blocks performed with local anesthetics and/or corticosteroids have demonstrated clinical benefit in the treatment of headache disorders, the duration of their efficacy is often limited. Pulsed radiofrequency (PRF) therapy has been introduced as a minimally invasive technique to prolong therapeutic effects. PRF modulates pain transmission by generating an electric field at the targeted nerve without causing structural damage to neural tissue or surrounding structures (3). A recent systematic review evaluating the efficacy and safety of greater occipital nerve pulsed radiofrequency in headache disorders reported that GON-PRF was effective in reducing pain intensity and headache frequency across various primary headache conditions, with a favorable safety profile.

Первичные конечные точки

  • Primary outcome [Срок оценки: baseline, 1st month, 3rd month]
  • Primary outcme [Срок оценки: baseline, 1st month, 3rd month]
  • Primary outcome [Срок оценки: baseline, 1st month, 3rd month.]
Вторичные конечные точки (2)
  • secondary outcome [Срок оценки: baseline]
  • secondary outcome [Срок оценки: baseline]

Критерии участия

Критерии включения

  • Age 65 years or older

Diagnosis of chronic migraine according to ICHD criteria

Presentation to the algology clinic

Eligibility for greater occipital nerve pulsed radiofrequency (GON-PRF) treatment according to the study protocol

Ability to provide written informed consent

Критерии исключения

  • Acute headache or pain conditions

Malignancy-related headache

Severe cognitive or communication impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Park D, Chang MC. The mechanism of action of pulsed radiofrequency in reducing pain: a narrative review. J Yeungnam Med Sci. 2022 Jul;39(3):200-205. doi: 10.12701/jyms.2022.00101. Epub 2022 Apr 7. PMID 35385898

Идентификаторы

NCT: NCT07363083 · 111213

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗