NCT07363083

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026May 2027

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 15, 2026

Last Update Submit

February 6, 2026

Conditions

Headache, Migraine

Keywords

Migraine HeadacheElderly, FrailNerve Blockade

Outcome Measures

Primary Outcomes (3)

  • Primary outcome

    VAS: Pain intensity, assessed by the Visual Analog Scale

    baseline, 1st month, 3rd month

  • Primary outcme

    Monthly headache frequency

    baseline, 1st month, 3rd month

  • Primary outcome

    Number of headache days per month

    baseline, 1st month, 3rd month.

Secondary Outcomes (2)

  • secondary outcome

    baseline

  • secondary outcome

    baseline

Study Arms (1)

GON_PRF group

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

65 years or over patients with chronical migraine

You may qualify if:

  • 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

You may not qualify if:

  • Acute headache or pain conditions
  • Malignancy-related headache
  • Severe cognitive or communication impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 35385898BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Ulku Sabunccu, Assoc. Prof.

CONTACT

+905337085212sabuncuulku@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-01