Status:
WITHDRAWN
Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Post-Traumatic Neuralgia
Occipital Neuralgia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Occipital neuralgia and subsequent headaches are associated with significant morbidity and impact quality of life and ability to work. Treatment is primarily medical and consists of non-steroidal anti...
Eligibility Criteria
Inclusion
- History of head or neck trauma as an inciting event for occipital headaches
- Occipital neuralgia headache, as diagnosed by neurologist, and as defined by the International Classification of Headache Disorders (ICHD-3). 13.4 - occipital neuralgia:
- Description:
- Unilateral or bilateral paroxysmal, shooting or stabbing pain in the posterior part of the scalp, in the distribution of the greater, lesser or third occipital nerves, sometimes accompanied by diminished sensation or dysaesthesia in the affected area and commonly associated with tenderness over the involved nerve(s).
- Diagnostic criteria:
- Unilateral or bilateral pain fulfilling criteria B-E
- Pain is located in the distribution of the greater, lesser and/or third occipital nerves
- Pain has two of the following three characteristics:
- recurring in paroxysmal attacks lasting from a few seconds to minutes
- severe intensity
- shooting, stabbing or sharp in quality
- Pain is associated with both of the following:
- dysaesthesia and/or allodynia apparent during innocuous stimulation of the scalp and/or hair
- either or both of the following:
- tenderness over the affected nerve branches
- trigger points at the emergence of the greater occipital nerve or in the area of distribution of C2
- Pain is eased temporarily by local anaesthetic block of the affected nerve
- Not better accounted for by another ICHD-3 diagnosis.
- Comments:
- The pain of 13.4 Occipital neuralgia may reach the fronto-orbital area through trigeminocervical interneuronal connections in the trigeminal spinal nuclei.
- 4 Occipital neuralgia must be distinguished from occipital referral of pain arising from the atlantoaxial or upper zygapophyseal joints or from tender trigger points in neck muscles or their insertions.
- Age: 18-65
- Male and female
Exclusion
- Headache of any etiology other than specified in the inclusion criteria.
- Patients with occipital referral of pain arising from the atlantoaxial or upper zygapophyseal joints or from tender trigger points in neck muscles or their insertions
- Pregnant or breastfeeding females
- Patients with significant comorbidities including short life expectancy, malignancy, degenerative central nervous system diseases, infection, severe psychiatric disorders
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03253523
Start Date
September 30 2019
End Date
February 1 2021
Last Update
March 10 2021
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612