Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 7:09 PM
Study NCT ID:
NCT04051203
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2019-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: