Back to resultsPost-traumatic Occipital Neuralgia - Surgical Versus Medical Management
Primary Purpose
Post-Traumatic Neuralgia, Occipital Neuralgia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occipital neurolysis
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Neuralgia
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
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Continued maximal medical management
Surgical occipital nerve neurolysis
Arm Description
Outcomes
Primary Outcome Measures
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
Headache days per month
Assess patient-reported number of days with headaches per month, in days
Duration of average headache
Assess patient-reported average duration of headaches, in hours
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.
Secondary Outcome Measures
Subjective patient recorded outcomes of quality of life
Assessment of quality of life using the Headache Impact Test (HIT-6) tool. The scores range from 36 to 78, with scores over 50 indicating some degree of impact of headaches on quality of life.
Medication intake
Patient-reported average intake of analgesic medications for occipital neuralgia pain
Engagement in activity pre- and post-operatively
Patient-reported ability to return to daily work and recreational activities. Outcome will be measured in days per month when patient stays home and is unable to work or otherwise engage in recreational activities secondary to migraine symptoms.
Patient satisfaction
Reported as the number of patients that answer "Yes" to question: 'Would you have the surgery again?'
Full Information
NCT ID
NCT03253523
First Posted
August 15, 2017
Last Updated
March 8, 2021
Sponsor
Rush University Medical Center
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03253523
Brief Title
Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
Official Title
Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Patients did not want to take part in the experimental arm of the study as all have opted for the current standard of care procedure.
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Neuralgia, Occipital Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continued maximal medical management
Arm Type
No Intervention
Arm Title
Surgical occipital nerve neurolysis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Occipital neurolysis
Intervention Description
Surgical occipital nerve decompression
Primary Outcome Measure Information:
Title
Average visual analogue scale of pain intensity
Description
Assess patient's average headache on a visual analog scale from 1-10, 10 being the worst pain
Time Frame
6 months
Title
Headache days per month
Description
Assess patient-reported number of days with headaches per month, in days
Time Frame
6 months
Title
Duration of average headache
Description
Assess patient-reported average duration of headaches, in hours
Time Frame
6 months
Title
Change in Migraine Headache Index (the multiple of scores 1-3) at 6 months
Description
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.
Time Frame
from baseline to 6 months
Secondary Outcome Measure Information:
Title
Subjective patient recorded outcomes of quality of life
Description
Assessment of quality of life using the Headache Impact Test (HIT-6) tool. The scores range from 36 to 78, with scores over 50 indicating some degree of impact of headaches on quality of life.
Time Frame
6 months
Title
Medication intake
Description
Patient-reported average intake of analgesic medications for occipital neuralgia pain
Time Frame
6 months
Title
Engagement in activity pre- and post-operatively
Description
Patient-reported ability to return to daily work and recreational activities. Outcome will be measured in days per month when patient stays home and is unable to work or otherwise engage in recreational activities secondary to migraine symptoms.
Time Frame
6 months
Title
Patient satisfaction
Description
Reported as the number of patients that answer "Yes" to question: 'Would you have the surgery again?'
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Dorafshar
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
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