Foothills Medical Center, Main Floor Special Services
Calgary, Alberta, T2N2T9, Canada
NCT Number: NCT04051203
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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Notify Me18 year and older
All sexes
Interventional
Phase 1
Calgary, Alberta, T2N2T9, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Steroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine.
2mL normal saline.
Time frame: Screening, pre-injection to 3-months post injection
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
Time frame: from immediately post-injection to 3-months, daily recording
Safety will be determined based on adverse reactions monitored through daily headache diary reporting and communication with the study team
Time frame: Pre-injection to 3 months post injection, daily recording.
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.
Time frame: Pre-injection to 3 months post injection, daily recording.
Using daily headache diaries, headache frequency will be collected.
Time frame: Pre-injection, 1 month, and 3 month time points.
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.
Time frame: Pre-injection, 1 month, and 3 month follow-ups.
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.
University of Calgary
Other
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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