ClinicalTrials.Veeva

Menu

Pulsed Radiofrequency in Chronic Headaches

A

Attikon University Hospital

Status

Unknown

Conditions

Headache

Treatments

Procedure: Pulsed radiofrequency of the occipital nerves

Study type

Observational

Funder types

Other

Identifiers

NCT04339335
AttikonH PRF STUDY

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

Loading...

Central trial contact

CHRYSANTHI BATISTAKI, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems