Pulsed Radiofrequency in Chronic Headaches

• Conditions: Headache

• Registration Number: NCT04339335
• Lead Sponsor: Attikon Hospital

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.

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Study First Posted: 2020-04-09
• Last Update Posted: 2020-04-09
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days with headache	12 months	days with headache per month

Secondary Outcome Measures

Name	Time	Method
pain during crisis	12 months	pain during crisis with Numeric Rating Scale 0-10
analgesics consumption	12 months	number of analgesics consumption per month
quality of life	12 months	quality of life by EQ5D

Trial Locations

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.; 🇬🇷 Athens, Greece