Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia

Study Overview
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Brief Summary
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This study is a randomized controlled trial, assessing the effect of a single platelet rich plasma (PRP) injection in post traumatic (concussive) greater occipital neuralgia. This study will compare the effects of a single PRP injection to injection with steroid and anesthetic. There will also be a third arm to the study, in which patients will receive an injection with normal saline. This study will assess the severity and frequency of headache symptoms before and after receiving the injection.

Detailed Description
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Each year, an estimated 69 million people suffer from traumatic brain injury/concussion worldwide. In most patients with concussion, symptoms improve within 3 months. However, in some persons, symptoms persist. The cause(s) of post-traumatic headache are not entirely clear, which limits treatment options. Sometimes, these headaches are caused by irritation to the greater occipital nerve, and pain originating from this area is called greater occipital neuralgia. These headaches are often treated with steroid injections to the affected nerve. However, the effect of the injection is usually short lasting and may not provide adequate pain relief. Therefore, other methods of treatment have been sought out. Platelet Rich Plasma (PRP) is an emerging biologic treatment. PRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules. PRP acts to reduce inflammation and encourage tissue repair at the site of injection. PRP is created by collecting a person's own blood, centrifuging it, and extracting the platelet-rich layer of plasma. This platelet rich mixture is then re-injected into the affected area. PRP is used as a safe and effective treatment in many fields, and is most commonly used in arthritis. PRP has recently been studied as a potential treatment for peripheral nerve disorders, such as carpal tunnel syndrome. Post-injection, a daily headache diary provided via mobile application (Secure RedCap) available in iPhone or android device will be provided to record daily records of numeric pain rating scale, headache frequency and medication-use.

Official Title
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Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study

Conditions
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Occipital Neuralgia, Headache

Intervention / Treatment
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* Biological: Autologous Platelet Rich Plasma Injection
* Drug: Depo-Medrol and lidocaine
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants will be males or females at least 18 years of age who suffer from post-traumatic headaches secondary to GON. Patients must fulfill the ICHD-3 criteria in establishing a diagnosis of GON. This diagnosis will be established by an experienced Physiatrist with extensive experience in headache and related disorders. To meet this criteria, patients must have experienced previous successful temporary relief with local anesthetic or steroid injection surrounding the GON in the past, but have not received local steroid injection within past 3 months. Pre-treatment numerical pain rating scale for daily headache intensity must be ≥4/10, with a headache frequency ≥10 days/month. Possible secondary causes of ON must be ruled out with reasonable level of investigation prior to enrollment. Exclusion Criteria: Inability to provide informed consent; history of surgery in the occipital region; unstable psychiatric or medical condition; rheumatologic or inflammatory disorders; widespread neurologic disorders (eg. MS); coagulopathy; immunosuppression; active cancer; herpes zoster infection in last 6 months; pregnancy; steroid or other local GON or LON infiltration in past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomized controlled trial, participants are randomly assigned to one of three groups; an autologous PRP injection, a steroid injection, or normal saline.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Platelet Rich Plasma Injection<br>PRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules. | Biological: Autologous Platelet Rich Plasma Injection<br>* 60mL of blood will be drawn from the antecubital vein and processed via centrifugation. Samples will be centrifuged as per manufacturer instructions, yielding 5mL of PRP. For quality testing, 1mL of PRP will be sent to the lab for analysis of platelet and leukocyte count, as compared to the patients' whole blood.<br>|
| Active Comparator: Standard Treatment<br>Steroid and anesthetic injection: the clinical standard. | Drug: Depo-Medrol and lidocaine<br>* Steroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine.<br>|
| Placebo Comparator: Normal Saline<br>Placebo injection, with no known treatment effects. | Other: Normal Saline<br>* 2mL normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the feasibility of platelet-rich plasma for patients with post-traumatic greater occipital neuralgia | The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol), and the acceptability of the protocol | Screening, pre-injection to 3-months post injection | 
| Evaluate the safety profile of platelet-rich plasma for the treatment of post-traumatic greater occipital neuralgia | Safety will be determined based on adverse reactions monitored through daily headache diary reporting and communication with the study team | from immediately post-injection to 3-months, daily recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache severity as measured by the Numerical Pain Raiting Scale (NPRS) | This will be measured as a greater than a 2-point decrease on the NPRS at 3 months post-injection in the PRP group as compared to steroid and saline groups. | Pre-injection to 3 months post injection, daily recording. | 
| Change in headache frequency (days per month with headache). | Using daily headache diaries, headache frequency will be collected. | Pre-injection to 3 months post injection, daily recording. | 
| Medication Usage | Using daily medication diaries, medication usage will be collected to track analgesic usage. | Pre-injection to 3 months post injection, daily recording. | 
| Headache Impact Test-6 | A valid and reliable 6-item questionnaire for assessment of the impact of headaches across different diagnostic groups of headaches. The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress. The HIT-6 also measures the severity of headache pain. | Pre-injection, 1 month, and 3 month time points. | 
| Quality of Life in Following Brain Injury Questionnaire | The QOLIBRI (Quality of Life after Brain Injury) is the first instrument specifically developed to assess health-related quality of life (HRQoL) of individuals after traumatic brain injury. The QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions of HRQoL after TBI. The questionnaire provides a profile of quality of life together with a total score. | Pre-injection, 1 month, and 3 month follow-ups. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GON, greater occipital neuralgia, post traumatic headache, post concussive headache