Pulsed Radiofrequency in Chronic Headaches

NCT ID: NCT04339335

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-12-31

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.

Conditions

Headache

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Pulsed radiofrequency of the occipital nerves

pulsed radiofrequency of the greater and lesser occipital nerves bilaterally

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chrysanthi Batistaki

Associate Professor of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

CHRYSANTHI BATISTAKI, MD, PhD

Role: CONTACT

chrysabatistaki@yahoo.gr

00302105832371

Facility Contacts

Chrysanthi Batistaki, MD, PhD

Role: primary

chrysabatistaki@yahoo.gr

0030 210 5832371

Other Identifiers

AttikonH PRF STUDY

Identifier Type: -

Identifier Source: org_study_id