Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management
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|ClinicalTrials.gov Identifier: NCT03253523|
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : February 12, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Neuralgia Occipital Neuralgia||Procedure: Occipital neurolysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
|No Intervention: Continued maximal medical management|
|Experimental: Surgical occipital nerve neurolysis||
Procedure: Occipital neurolysis
Surgical occipital nerve decompression
- 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.
- Subjective patient recorded outcomes of quality of life [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]Patient-reported average intake of analgesic medications for occipital neuralgia pain
- Engagement in activity pre- and post-operatively [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]Reported as the number of patients that answer "Yes" to question: 'Would you have the surgery again?'
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253523
|Contact: Amir Dorafsharfirstname.lastname@example.org|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Amir Dorafshar 312-563-3000 email@example.com|
|Principal Investigator:||Amir Dorafshar||Rush University Medical Center|