Pulsed Radiofrequency in Chronic Headaches

Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.

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

Study Overview

• Status: Unknown
• Conditions: Headache
• Intervention / Treatment: Procedure: Pulsed radiofrequency of the occipital nerves

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 12462
    • Recruiting
    • 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days with headache	days with headache per month	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain during crisis	pain during crisis with Numeric Rating Scale 0-10	12 months
analgesics consumption	number of analgesics consumption per month	12 months
quality of life	quality of life by EQ5D	12 months

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (ACTUAL): April 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders
• Other Study ID Numbers: AttikonH PRF STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No