Pulsed Radiofrequency in Chronic Headaches
Keywords
Abstract
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.
Dates
Last Verified: | 03/31/2020 |
First Submitted: | 04/05/2020 |
Estimated Enrollment Submitted: | 04/05/2020 |
First Posted: | 04/08/2020 |
Last Update Submitted: | 04/05/2020 |
Last Update Posted: | 04/08/2020 |
Actual Study Start Date: | 02/28/2019 |
Estimated Primary Completion Date: | 11/30/2020 |
Estimated Study Completion Date: | 11/30/2021 |
Condition or disease
Intervention/treatment
Procedure: Pulsed radiofrequency of the occipital nerves
Phase
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | Yes |
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 |
Outcome
Primary Outcome Measures
1. Days with headache [12 months]
Secondary Outcome Measures
1. pain during crisis [12 months]
2. analgesics consumption [12 months]
3. quality of life [12 months]