Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management

NCT03253523 | Withdrawn

• 1 other identifier: IRB00148116
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Neuralgia; Occipital Neuralgia

Outcome Measures

Primary Outcomes (4)

• Average visual analogue scale of pain intensity

  Assess patient's average headache on a visual analog scale from 1-10, 10 being the worst pain

  6 months

• Headache days per month

  Assess patient-reported number of days with headaches per month, in days

  6 months

• Duration of average headache

  Assess patient-reported average duration of headaches, in hours

  6 months

• Change in Migraine Headache Index (the multiple of scores 1-3) at 6 months

  The Migraine Headache Index (MHI) is a commonly used metric in the plastic and reconstructive surgery literature to assess pre- and postoperative headache severity. The score is a product of headache duration (in days), frequency (in days per month), and severity (on a scale from 1 to 10). The score ranges from 0 to 300, with higher scores corresponding to worse migraine symptoms. Change in MHI score between pre-operative and 6-month postoperatively will be assessed.

  from baseline to 6 months

Secondary Outcomes (4)

• Subjective patient recorded outcomes of quality of life

  6 months

• Medication intake

  6 months

• Engagement in activity pre- and post-operatively

  6 months

• Patient satisfaction

  6 months

Study Arms (2)

Continued maximal medical management

NO INTERVENTION

Surgical occipital nerve neurolysis

EXPERIMENTAL

Procedure: Occipital neurolysis

Interventions

Occipital neurolysis PROCEDURE

Surgical occipital nerve decompression

Surgical occipital nerve neurolysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Study Officials

• Amir Dorafshar

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 18, 2017
• Study Start: September 30, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

US (1)