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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04051203
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of adverse events [ Time Frame: Pre-injection to 3 months post injection, daily recording. ]
    Daily adverse event reporting as entered on headache diaries.

  4. 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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Chantel Debert, MD, FRCPC (403) 944-1580 chantel.debert@albertahealthservices.ca
Contact: Jacqueline E Stone, MD, MBA (403) 915-5625 jestone@ucalgary.ca

Locations
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Canada, Alberta
Foothills Medical Center, Main Floor Special Services Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Chantel Debert, MD, FRCPC    (403) 944-1580    chantel.debert@albertahealthservices.ca   
Contact: Jacqueline E Stone, MD, MBA    (403) 915-5625    jestone@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
More Information
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Publications:

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04051203    
Other Study ID Numbers: REB18-1368
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan, all participant data will be kept on a secured REDCap database.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
GON
greater occipital neuralgia
post traumatic headache
post concussive headache
Additional relevant MeSH terms:
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Neuralgia
Headache
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents