Treatment Response to GON Pulsed Radiofrequency in Elderly Patients With Chronic Migraine (FRAIL-GON)

Ankara City Hospital

Status: Begins enrollment this month

Conditions: Headache, Migraine

Study type: Observational

Funder types: Other

Identifiers

NCT07363083

111213

Details and patient eligibility

About

Headache disorders are common in older adults, and their management is often challenging due to comorbidities, polypharmacy, and limited evidence from geriatric populations. As most clinical trials exclude elderly patients, there is a need for effective and safe non-pharmacological treatment options for headache in this age group.

Greater occipital nerve blocks are widely used in the treatment of migraine and other headache disorders, but their clinical effect is often short-lived. Pulsed radiofrequency (PRF) has been introduced to prolong therapeutic benefit by modulating pain transmission without causing neural injury. Although greater occipital nerve pulsed radiofrequency (GON-PRF) has shown efficacy in various headache disorders, its effectiveness in patients aged 65 years and older has not been adequately studied.

The primary aim of this study is to evaluate the effectiveness of GON-PRF in patients aged ≥65 years with chronic migraine by assessing pain intensity, monthly headache days, and severe headache days. The secondary aim is to identify geriatric predictors of treatment response, including frailty status and the Geriatric Nutritional Risk Index (GNRI), to support individualized treatment strategies in older adults.

Full description

Headache disorders are common across all age groups. As the global population ages, the number of older patients with headache disorders continues to increase, 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 first. 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 can be complex and challenging, as it requires consideration of multiple factors, including comorbidities, polypharmacy, drug interactions, and adverse effects. Furthermore, evidence guiding headache treatment in older adults is limited, as most published clinical studies have excluded elderly patient populations. Consequently, clinicians require effective treatment options for headache in older adults, particularly non-pharmacological approaches that are less affected by comorbid conditions.

Peripheral nerve blocks, particularly greater occipital nerve blocks (GONB), have long been used to treat 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 profiles 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 benefit in the treatment of headache disorders, their duration of efficacy appears to be limited. Pulsed radiofrequency (PRF) therapy has been introduced to prolong this therapeutic effect. 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 effectively manages various headache

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Acute headache or pain conditions

Malignancy-related headache

Severe cognitive or communication impairment

Trial design

100 participants in 1 patient group

GON_PRF group

Description:

This study is a single-center, prospective, single-arm interventional clinical trial designed to evaluate the effectiveness of greater occipital nerve pulsed radiofrequency (GON-PRF) treatment and to identify predictors of treatment response in patients aged 65 years and older with a diagnosis of chronic migraine. Within the scope of the study, patients presenting to the algology clinic who meet the inclusion criteria will undergo ultrasound-guided GON-PRF treatment in accordance with standard clinical practice.