Clinical trial NCT04339335: Pulsed Radiofrequency in Chronic Headaches
Official title: Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Headache
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Days with headache
timeFrame: 12 months
Secondary outcomes:
measure: pain during crisis
timeFrame: 12 months
measure: analgesics consumption
timeFrame: 12 months
measure: quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Study officials:
References: