Clinical trial NCT03253523: Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
Official title: Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-Traumatic Neuralgia
Occipital Neuralgia
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2017-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-inflammatory medications and medications to treat neuropathic pain. Many patient exhaust medical management options and suffer from persistent symptoms.

Surgical management of chronic headaches including occipital neuralgia is emerging as a tool to relieve pain and the burden of morbidity associated with this condition. Dr. Bahman Guyuron has been reporting positive results in the literature for the past 20 years. In a systematic review of 14 papers it has been demonstrated that peripheral nerve surgery for migraines is effective and leads to an improvement of symptoms for 86% of patients. Complication rates were low across all studies included. Additionally, Dr Ivica Ducic has reported success specifically treating occipital neuralgia headaches, with significant improvements in subjective pain outcomes post-operatively. The mechanism behind this is thought to be similar to carpal tunnel syndrome, whereby peripheral nerve compression causes nerve irritation and pain. The ensuing inflammatory response to tissue injury can cause sensitization of nociceptors, resulting in hyperalgesia or allodynia. Surgical release of tight surrounding soft tissues results in nerve decompression and relief of symptoms.

Although there are multiple case series and empiric evidence supporting the safety and efficacy of occipital migraine surgery, there are no randomized controlled studies comparing surgical intervention with continued medical management.

As part of the present study, the investigators intend to randomize patients who have exhausted maximal medical treatment of post-traumatic occipital headaches to either a surgical management group or a continued medical management group. Surgical intervention will consist of neurolysis, or release, of the occipital nerves.


Eligibility criteria: Inclusion Criteria:

* 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.

13.4 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 Criteria:

* 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

Primary outcomes:
measure: Average visual analogue scale of pain intensity
timeFrame: 6 months
measure: Headache days per month
timeFrame: 6 months
measure: Duration of average headache
timeFrame: 6 months
measure: Change in Migraine Headache Index (the multiple of scores 1-3) at 6 months
timeFrame: from baseline to 6 months
Secondary outcomes:
measure: Subjective patient recorded outcomes of quality of life
timeFrame: 6 months
measure: Medication intake
timeFrame: 6 months
measure: Engagement in activity pre- and post-operatively
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Amir Dorafshar
role: PRINCIPAL_INVESTIGATOR
References: