Clinical trial NCT04051203: Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia
Official title: Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Occipital Neuralgia
Headache
Keywords: GON
greater occipital neuralgia
post traumatic headache
post concussive headache
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized controlled trial, participants are randomly assigned to one of three groups; an autologous PRP injection, a steroid injection, or normal saline.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the feasibility of platelet-rich plasma for patients with post-traumatic greater occipital neuralgia
timeFrame: Screening, pre-injection to 3-months post injection
measure: Evaluate the safety profile of platelet-rich plasma for the treatment of post-traumatic greater occipital neuralgia
timeFrame: from immediately post-injection to 3-months, daily recording
Secondary outcomes:
measure: Change in headache severity as measured by the Numerical Pain Raiting Scale (NPRS)
timeFrame: Pre-injection to 3 months post injection, daily recording.
measure: Change in headache frequency (days per month with headache).
timeFrame: Pre-injection to 3 months post injection, daily recording.
measure: Headache Impact Test-6
timeFrame: Pre-injection, 1 month, and 3 month time points.
measure: Quality of Life in Following Brain Injury Questionnaire
timeFrame: Pre-injection, 1 month, and 3 month follow-ups.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center, Main Floor Special Services
state: Alberta
Study officials:
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