Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04051203|
Recruitment Status : Unknown
Verified July 2019 by University of Calgary.
Recruitment status was: Recruiting
First Posted : August 9, 2019
Last Update Posted : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Occipital Neuralgia Headache||Biological: Autologous Platelet Rich Plasma Injection Drug: Depo-Medrol and lidocaine Other: Normal Saline||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|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.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||All members of the study will be blinded (participants and healthcare practioners) except for the study coordinator.|
|Official Title:||Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Autologous Platelet Rich Plasma Injection
PRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules.
Biological: 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. 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.
Active Comparator: Standard Treatment
Steroid and anesthetic injection: the clinical standard.
Drug: Depo-Medrol and lidocaine
Steroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine.
Placebo Comparator: Normal Saline
Placebo injection, with no known treatment effects.
Other: Normal Saline
2mL normal saline.
- Change in headache severity as measured by the Numerical Pain Raiting Scale (NPRS) [ Time Frame: Pre-injection to 3 months post injection, daily recording. ]The primary outcome will be 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.
- Change in headache frequency (days per month with headache). [ Time Frame: Pre-injection to 3 months post injection, daily recording. ]Using daily headache diaries, headache frequency will be collected.
- Medication Usage [ Time Frame: Pre-injection to 3 months post injection, daily recording. ]Using daily medication diaries, medication usage will be collected to track analgesic usage.
- Number of adverse events [ Time Frame: Pre-injection to 3 months post injection, daily recording. ]Daily adverse event reporting as entered on headache diaries.
- Headache Impact Test-6 [ 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.
- Quality of Life in Following Brain Injury Questionnaire [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051203
|Contact: Chantel Debert, MD, FRCPC||(403) firstname.lastname@example.org|
|Contact: Jacqueline E Stone, MD, MBA||(403) email@example.com|
|Foothills Medical Center, Main Floor Special Services||Recruiting|
|Calgary, Alberta, Canada, T2N2T9|
|Contact: Chantel Debert, MD, FRCPC (403) 944-1580 firstname.lastname@example.org|
|Contact: Jacqueline E Stone, MD, MBA (403) 915-5625 email@example.com|