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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07363083
Acronym
FRAIL-GON
Enrollment
100
Registered
2026-01-23
Start date
2026-03-01
Completion date
2027-05-01
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine

Keywords

Migraine Headache, Elderly, Frail, Nerve Blockade

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary outcomebaseline, 1st month, 3rd monthVAS: Pain intensity, assessed by the Visual Analog Scale
Primary outcmebaseline, 1st month, 3rd monthMonthly headache frequency

Secondary

MeasureTime frameDescription
secondary outcomebaselineBaseline frailty index

Contacts

CONTACTUlku Sabunccu, Assoc. Prof.
sabuncuulku@gmail.com+905337085212

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026