Peripheral nerve decompression surgery as treatment of secondary headache caused by entrapment neuropathy of extracranial sensory nerves

Conditions: headache to nerve compression
Neuralgia
10034606

Registration Number: NL-OMON49524

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

- A local headache suspected to be neuralgia caused by compression neuropathy
of one of
the following peripheral nerves:
* Supraorbital nerve
* Supratrochlear nerve
* Auriculotemporal nerve
* Zygomaticotemporal nerve
* Greater occipital nerve
* Lesser occipital nerve
* Third occipital nerve

- The local headache not better accounted for by another headache diagnosis
(although
coexistence is possible)

Exclusion Criteria

- Known allergic reaction to bupivacaine
- Cranial defects
- Contraindications for general anesthesia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain score: average daily headache intensity<br /><br>o Measurement of headache intensity on a 10 point VAS.<br /><br>o Measure daily in a diary<br /><br>o Clinically relevant decrease defined as 50% or more</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Frequency of headache, defined as the number of days with headache per 28 days<br /><br>- Frequency of serious headache, defined as the number of days with headache<br /><br>per 28 days with a VAS of 5 or higher<br /><br>- Change in frequency of days with acute headache medication use per 28 days<br /><br>- Change in frequency of days with prophylactic medication use per 28 days<br /><br>- Change in frequency of days with analgesic medication use per 28 days<br /><br>- Loss of work.<br /><br>- CEQ<br /><br>- HIT-6<br /><br>- SF-36</p><br>