Intra-articular Corticosteroid Injections to Platelet Rich Plasma (PRP) for Cervical Facetogenic Pain (PRICE)

August 19, 2024 updated by: Lawson Health Research Institute

A Pilot Study Comparing Intra-articular Corticosteroid Injections to Platelet Rich Plasma (PRP) as a Treatment for Cervical Facetogenic Pain

Chronic neck pain, either after trauma (e.g. whiplash injury) or due to arthritis, is a significant issue for many Canadians. Steroid injections into the small joints of the neck can provide temporary pain relief, but patients require repeat injections every few months. The investigator will assess whether a different type of injection (platelet-rich plasma, PRP) can provide enhanced and longer-lasting pain relief compared to steroid. PRP is made from the patient's own blood but contains higher levels of components that promote healing. Patients with neck pain will receive either an injection of steroid or PRP into the small joints of the neck, but they won't know which one they are getting. After the injection they will be contacted to answer questions about their pain and function, up to 12 months after injection. The goal of this study is to determine if PRP is a viable alternative to current treatments to help reduce chronic neck pain and improve function after a whiplash injury. PRP may be a more permanent treatment for chronic neck pain which could reduce the need for repeated injections, thus reducing health care costs and wait times.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The project utilizes a randomized control trial design. Ethics approval was obtained from the Western Research Ethics Board. Participants with chronic neck pain will be recruited from the SJHC Pain Clinic.

Eligible candidates who consent to study participation will be block randomized using randomizer.org into two groups (A or B). All patients will be blinded both before and after injections as to which therapy they receive. Group A will receive an intra-articular (IA) injection of autologous PRP (0.5 mL per level) and Group B will receive IA injections of corticosteroid (1.5 mL per level).

PRP: PRP preparation will occur at St. Joseph's Hospital using a standard 2-step centrifugation method. The Co-Investigator will draw 5-10cc of venous blood under sterile conditions (all patients) and subsequently centrifuge these samples at 200g for 10 minutes at room temperature. The plasma will then be separated from the sedimented erythrocytes and centrifuged again at 400g for 10 min to remove additional platelet-poor plasma. Finally, 1-2cc of PRP will be prepared for intra-articular injection. To maintain blinding, those in Group B will also have blood collection done, although their samples will not be injected.

Corticosteroid: 0.5 cc saline and 0.5cc of 10 mg/mL dexamethasone per facet joint (up to 6 mL total volume for 4 facet injections) will be prepared by the Principal Investigator or Co-Investigator.

Depending on randomization, the appropriate syringe will be delivered to the SJHC Pain Clinci interventional suite immediately after preparation. All injections will be performed by the same physician under fluoroscopic guidance at the same level(s) as the prior successful medial branch blocks. A small amount of contrast will be injected to ensure IA placement. It is recognized that IA placement may not be possible in every situation. It will be noted by the physician whether the injection is felt to be peri- or intra-articular.

Follow-up: Primary and secondary outcomes will be collected via phone or in person, pre-injection, and at 1, 3, and 6 months post-injection. If there is ongoing benefit ≥2 points on the NRS at 6 months, additional follow-up of primary and secondary outcomes at 9 and 12 months will be done.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6J3T9
        • St. Joseph's Health Care London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years old
  • Facetogenic neck pain at least 4/10 on NRS after whiplash injury
  • At least 50% relief of familiar neck pain after dual cervical medial branch blocks

Exclusion Criteria:

  • Suspected serious spinal pathology
  • Fracture/dislocation at time of injury
  • Nerve root compromise
  • Spinal surgery or RFN in the past 12 months
  • Prior corticosteroid cervical facet injection in past 6 months
  • History of any uncontrolled mental health conditions
  • Other contraindications to spinal injections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet Rich Plasma
One time injection of 1.5-6cc of platelet rich plasma prepared from a blood sample into cervical facet joints. There is no trade/generic name
Drug: Intraarticular platelet rich plasma cervical facet injection
Injection of PRP into the cervical facet joints.
Other Names:
  • PRP injection
Active Comparator: Dexamethasone Sodium Phosphate
Corticosteroid: 0.5 cc saline and 0.5cc of 10 mg/mL dexamethasone per facet joint (up to 6 mL total volume for 4 facet injections)
Drug: Corticosteroid injection
Injection of corticosteroid into the cervical facet joints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months
Numeric Rating Scale (NRS) rating from 0-10, 0 indicating no pain, and 10 indicating worst pain
Baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months
Proportion attaining at least a 2 point reduction in pain on Numeric Rating Scale
Time Frame: 12 months
Measured by Numeric Rating Scale questionnaire scores at Baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. rating from 0-10, 0 indicating no pain, and 10 indicating worst pain
12 months
Proportion attaining 90% and 50% pain relief on Numeric Rating Scale
Time Frame: 12 months
Measured by Numeric Rating Scale scores at Baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. rating from 0-10, 0 indicating no pain, and 10 indicating worst pain
12 months
Time to return of at least 50% baseline pain on Numeric Rating Scale
Time Frame: 12 months
Measured by Numeric Rating Scale questionnaire scores at baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. rating from 0-10, 0 indicating no pain, and 10 indicating worst pain.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 months
Including : increased pain, bleeding, infection, allergy, neurologic deficit, new hyperglycemia. Adverse events will be recorded through case report forms and reported to the principal investigator. Side effects will be assessed using standardized case report forms at each visit. Participants are encouraged to contact the coordinator to report any concerns.
12 months
Patient reported function in the presence of neck pain
Time Frame: 12 months
Measured by the Neck Disability Index questionnaire, which is not a scale.
12 months
Patient's subjective satisfaction with the procedure
Time Frame: 12 months
Measured by Modified MacNab criteria questionnaire at baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. The MacNab criteria answers range from 1-4, 1 being excellent and 4 being poor.
12 months
Work Productivity and Activity
Time Frame: 12 months
Change from baseline to end of study in the Work Productivity and Activity Questionnaire: Specific Health Impairment Version 2 (not a scale)
12 months
Self efficacy
Time Frame: 12 weeks.
measured by self efficacy while performing daily activities in chronic WAD questionnaire.
12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Eldon Loh, MD, St. Joseph's Healthcare London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

March 26, 2023

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELPRP01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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