Pulsed Radiofrequency in Chronic Headaches

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

Detailed Description
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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.

Official Title
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Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.

Conditions
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Headache

Intervention / Treatment
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* Procedure: Pulsed radiofrequency of the occipital nerves


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pulsed radiofrequency of the occipital nerves|pulsed radiofrequency of the greater and lesser occipital nerves bilaterally|

What is the study measuring?
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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 |