To evaluate the effect of peripheral nerve decompression surgery in patients with headache caused by entrapment neuropathy,comparing it to conventional treatment.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Surgical decompression of peripheral sensory nerves seems to be an effective
way of treating headaches in patients with
diagnostically confirmed entrapment neuropathy. This is mostly based on
prospective cohort studies. Well-designed randomised
controlled trials to prove the effect of surgery compared to standard treatment
or available non-surgical options are limited.
Study objective
To evaluate the effect of peripheral nerve decompression surgery in patients
with headache caused by entrapment neuropathy,
comparing it to conventional treatment.
Study design
Randomised controlled trial, with a follow up using a daily diary for one year
and questionnaires at three months, one year and five
years.
Intervention
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 neurologist.
Study burden and risks
The burden consists of a maximum of seven visits to the outpatient clinic,
three undergoing physical examination, one with
diagnostic imaging modalities (resulting in low dose radiation from a CT scan)
and one where a diagnostic nerve block is performed. A daily headache diary is
kept (a frequently used tool by neurologists) and two questionnaires that are
filled out three times during the study. There are no major adverse events
described of surgical decompression in the head and neck area. Minor adverse
events include itching, numbness, hyper- or hyposensitivity and operative-site
specific adverse events such as hair loss, temporal hollowing or neck
stiffness. Decompression surgery significantly decrease the intensity and
frequency of headaches in carefully selected patients, which outweighs the
burden and risk of the study procedure.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74628.078.20 |