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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49524
Enrollment
70
Registered
2020-11-10
Start date
2020-08-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

headache to nerve compression Neuralgia

Interventions

Diagnostic nerve block at the site of local pain to confirm entrapment neuropathy. If successful the subject is randomised between surgical decompression or the standard medical treatment by the neu

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pain score: average daily headache intensity o Measurement of headache intensity on a 10 point VAS. o Measure daily in a diary o Clinically relevant decrease defined as 50% or more

Secondary

MeasureTime frame
- Frequency of headache, defined as the number of days with headache per 28 days - Frequency of serious headache, defined as the number of days with headache per 28 days with a VAS of 5 or higher - Change in frequency of days with acute headache medication use per 28 days - Change in frequency of days with prophylactic medication use per 28 days - Change in frequency of days with analgesic medication use per 28 days - Loss of work. - CEQ - HIT-6 - SF-36

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)