Post-Traumatic NeuralgiaNCT03253523
Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
A study testing Occipital neurolysis in people with Post-Traumatic Neuralgia and Occipital Neuralgia, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Neuralgia, Occipital Neuralgia
- What is being tested?
- Occipital neurolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read more
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
- Being tested
- Occipital neurolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital neurolysisProcedure or surgery
Surgical occipital nerve decompression
| Study group | Role | What they receive |
|---|---|---|
| Continued maximal medical management | No intervention | Not described |
| Surgical occipital nerve neurolysis | Experimental | Not described Receives: Procedure: Occipital neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Headache days per month
Assess patient-reported number of days with headaches per month, in days
Measured: 6 months
Duration of average headache
Assess patient-reported average duration of headaches, in hours
Measured: 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.
Measured: from baseline to 6 months
Secondary outcomes (4)
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.
Measured: 6 months
Medication intake
Patient-reported average intake of analgesic medications for occipital neuralgia pain
Measured: 6 months
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.
Measured: 6 months
Patient satisfaction
Reported as the number of patients that answer "Yes" to question: 'Would you have the surgery again?'
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start30 Sep 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Amir Dorafshar, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253523
- Sponsor's protocol ID
- IRB00148116
- Status last verified
- Mar 2021
- First submitted
- 15 Aug 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
- ClinicalTrials.gov ID
- NCT03253523
- Acronym / sponsor ID
- IRB00148116
- Conditions
- Post-Traumatic Neuralgia, Occipital Neuralgia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued maximal medical management | No intervention | – |
| Surgical occipital nerve neurolysis | Experimental | Procedure: Occipital neurolysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- 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).
- Unilateral or bilateral pain fulfilling criteria B-E
- Pain is located in the distribution of the greater, lesser and/or third occipital nerves
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occipital neurolysisSurgical occipital nerve decompression | Procedure or surgery | Surgical occipital nerve neurolysis |
Primary outcome
Average visual analogue scale of pain intensity
Time frame: 6 months
Assess patient's average headache on a visual analog scale from 1-10, 10 being the worst pain
Headache days per month
Time frame: 6 months
Assess patient-reported number of days with headaches per month, in days
Duration of average headache
Time frame: 6 months
Assess patient-reported average duration of headaches, in hours
Change in Migraine Headache Index (the multiple of scores 1-3) at 6 months
Time frame: from baseline to 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.
4 secondary outcomes
Subjective patient recorded outcomes of quality of life
Time frame: 6 months
Medication intake
Time frame: 6 months
Engagement in activity pre- and post-operatively
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Dorafshar principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipital neurolysis in people with Post-Traumatic Neuralgia and Occipital Neuralgia, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average visual analogue scale of pain intensity (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.