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Clinical Trials/NCT04339335
NCT04339335
Unknown
Not Applicable

Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.

Attikon Hospital1 site in 1 country50 target enrollmentMarch 1, 2019
ConditionsHeadache

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Headache
Sponsor
Attikon Hospital
Enrollment
50
Locations
1
Primary Endpoint
Days with headache
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
December 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Attikon Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chrysanthi Batistaki

Associate Professor of Anaesthesiology

Attikon Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Days with headache

Time Frame: 12 months

days with headache per month

Secondary Outcomes

  • pain during crisis(12 months)
  • analgesics consumption(12 months)
  • quality of life(12 months)

Study Sites (1)

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