Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia
NCT ID: NCT04051203
Last Updated: 2024-02-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
35 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-02-01
Study Completion Date
2023-12-01
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.
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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.
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.
Conditions
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Occipital Neuralgia
Headache
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Randomized controlled trial, participants are randomly assigned to one of three groups; an autologous PRP injection, a steroid injection, or normal saline.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
All members of the study will be blinded (participants and healthcare practioners) except for the study coordinator.
Study Groups
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Autologous Platelet Rich Plasma Injection
PRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules.
Group Type
EXPERIMENTAL
Autologous Platelet Rich Plasma Injection
Intervention Type
BIOLOGICAL
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.
Standard Treatment
Steroid and anesthetic injection: the clinical standard.
Group Type
ACTIVE_COMPARATOR
Depo-Medrol and lidocaine
Intervention Type
DRUG
Steroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine.
Normal Saline
Placebo injection, with no known treatment effects.
Group Type
PLACEBO_COMPARATOR
Normal Saline
Intervention Type
OTHER
2mL normal saline.
Interventions
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Autologous Platelet Rich Plasma Injection
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.
Intervention Type
BIOLOGICAL
Depo-Medrol and lidocaine
Steroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine.
Intervention Type
DRUG
Normal Saline
2mL normal saline.
Intervention Type
OTHER
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Calgary
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Foothills Medical Center, Main Floor Special Services
Calgary, Alberta, Canada
Site Status
Countries
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Canada
References
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DERIVED
Stone JE, Fung TS, Machan M, Campbell C, Shan RLP, Debert CT. Ultrasound-guided platelet-rich plasma injections for post-traumatic greater occipital neuralgia: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Jun 22;7(1):130. doi: 10.1186/s40814-021-00867-3.
Reference Type
DERIVED
Other Identifiers
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REB18-1368
Identifier Type: -
Identifier Source: org_study_id
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