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Pulsed Radiofrequency in Chronic Headaches

Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04339335
Enrollment
50
Registered
2020-04-09
Start date
2019-03-01
Completion date
2021-12-31
Last updated
2020-04-09

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

Conditions

Headache

Brief summary

Pulsed radiofrequency of the occipital nerves (greater and lesser) for primary headache management.

Detailed description

Patients participating suffered from primary headaches (migraine, cluster, and tension headache) and occipital neuralgia were enrolled in the study. They have all received in the past the standard systemic pharmacotherapy prophylaxis for headache management (with topiramate or amitriptylline) as well as tryptanes for rescue treatment, and were scheduled for a diagnostic nerve block of the occipital nerves in cases of intractable pain. Inclusion criteria included: not adequate response to systemic pharmacotherapy, pain over crises of \>4/10, occipital tenderness bilaterally or unilaterally, and days with headache of more than 10/month. Exclusion criteria were age\<18 years old, pregnancy or lactation, presence of cardiac pacemaker, previous therapy with PRF, severe psychiatric disorder and patient refusal. In cases of a positive response to the diagnostic nerve block with local anesthetic, with \>50% pain relief they were scheduled for pulsed radiofrequency of GON and LON bilaterally. Primary outcome measure was the days with headache per month, before and after treatment. In addition, pain during headache crisis (with Visual Analogue Scale, VAS, 0-10), the analgesic consumption (number per month) and the quality of life (measured with EQ6D) were studied. All measurements were performed before treatment, as well as after 1, 3, 6, and 12 months. All patients completed the Brief Pain Inventory questionnaire in Greek language and signed an informed consent prior treatment. All measurements were accomplished by an independed (blinded) researcher of the pain unit. All complications and side effects were also recorded.

Interventions

PROCEDUREPulsed radiofrequency of the occipital nerves

pulsed radiofrequency of the greater and lesser occipital nerves bilaterally

Sponsors

Attikon Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* not adequate response to systemic pharmacotherapy * pain over crises of \>4/10 * occipital tenderness bilaterally or unilaterally, * days with headache of more than 10/month.

Exclusion criteria

* age\<18 years old, * pregnancy or lactation * presence of cardiac pacemaker * previous therapy with PRF * severe psychiatric disorder * severe coagulopathy * patient refusal

Design outcomes

Primary

MeasureTime frameDescription
Days with headache12 monthsdays with headache per month

Secondary

MeasureTime frameDescription
pain during crisis12 monthspain during crisis with Numeric Rating Scale 0-10
analgesics consumption12 monthsnumber of analgesics consumption per month
quality of life12 monthsquality of life by EQ5D

Countries

Greece

Contacts

Primary ContactCHRYSANTHI BATISTAKI, MD, PhD
chrysabatistaki@yahoo.gr00302105832371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026