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

NCT04392999 | Completed Phase 2

• 1 other identifier: ELPRP01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Pain

Keywords

cervical pain; neck pain; platelet rich plasma; PRP

Outcome Measures

Primary Outcomes (4)

• Pain intensity

  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

  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

  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

  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 Outcomes (5)

• Adverse Events

  12 months

• Patient reported function in the presence of neck pain

  12 months

• Patient's subjective satisfaction with the procedure

  12 months

• Work Productivity and Activity

  12 months

• Self efficacy

  12 weeks.

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

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

Dexamethasone Sodium Phosphate

ACTIVE COMPARATOR

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

Interventions

Intraarticular platelet rich plasma cervical facet injection DRUG

Injection of PRP into the cervical facet joints.

Also known as: PRP injection

Platelet Rich Plasma

Corticosteroid injection DRUG

Injection of corticosteroid into the cervical facet joints.

Dexamethasone Sodium Phosphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6J3T9, Canada

Location

Related Publications (17)

• Carroll LJ, Holm LW, Hogg-Johnson S, Cote P, Cassidy JD, Haldeman S, Nordin M, Hurwitz EL, Carragee EJ, van der Velde G, Peloso PM, Guzman J; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Course and prognostic factors for neck pain in whiplash-associated disorders (WAD): results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S83-92. doi: 10.1097/BRS.0b013e3181643eb8.

  PMID: 18204405 BACKGROUND

• Lim JW, Cho YW, Lee DG, Chang MC. Comparison of Intraarticular Pulsed Radiofrequency and Intraarticular Corticosteroid Injection for Management of Cervical Facet Joint Pain. Pain Physician. 2017 Sep;20(6):E961-E967.

  PMID: 28934800 BACKGROUND

• Manchikanti L. Role of neuraxial steroids in interventional pain management. Pain Physician. 2002 Apr;5(2):182-99.

  PMID: 16902669 BACKGROUND

• McDonald GJ, Lord SM, Bogduk N. Long-term follow-up of patients treated with cervical radiofrequency neurotomy for chronic neck pain. Neurosurgery. 1999 Jul;45(1):61-7; discussion 67-8. doi: 10.1097/00006123-199907000-00015.

  PMID: 10414567 BACKGROUND

• Monfett M, Harrison J, Boachie-Adjei K, Lutz G. Intradiscal platelet-rich plasma (PRP) injections for discogenic low back pain: an update. Int Orthop. 2016 Jun;40(6):1321-8. doi: 10.1007/s00264-016-3178-3. Epub 2016 Apr 12.

  PMID: 27073034 BACKGROUND

• Podd D. Platelet-rich plasma therapy: origins and applications investigated. JAAPA. 2012 Jun;25(6):44-9. doi: 10.1097/01720610-201206000-00009. No abstract available.

  PMID: 22693884 BACKGROUND

• Quinn KP, Winkelstein BA. Detection of altered collagen fiber alignment in the cervical facet capsule after whiplash-like joint retraction. Ann Biomed Eng. 2011 Aug;39(8):2163-73. doi: 10.1007/s10439-011-0316-3. Epub 2011 May 3.

  PMID: 21538155 BACKGROUND

• Teasell RW, McClure JA, Walton D, Pretty J, Salter K, Meyer M, Sequeira K, Death B. A research synthesis of therapeutic interventions for whiplash-associated disorder (WAD): part 5 - surgical and injection-based interventions for chronic WAD. Pain Res Manag. 2010 Sep-Oct;15(5):323-34. doi: 10.1155/2010/914358.

  PMID: 21038011 BACKGROUND

• Wu J, Zhou J, Liu C, Zhang J, Xiong W, Lv Y, Liu R, Wang R, Du Z, Zhang G, Liu Q. A Prospective Study Comparing Platelet-Rich Plasma and Local Anesthetic (LA)/Corticosteroid in Intra-Articular Injection for the Treatment of Lumbar Facet Joint Syndrome. Pain Pract. 2017 Sep;17(7):914-924. doi: 10.1111/papr.12544. Epub 2017 Feb 22.

  PMID: 27989008 BACKGROUND

• Barnsley L, Lord SM, Wallis BJ, Bogduk N. Lack of effect of intraarticular corticosteroids for chronic pain in the cervical zygapophyseal joints. N Engl J Med. 1994 Apr 14;330(15):1047-50. doi: 10.1056/NEJM199404143301504.

  PMID: 8127332 BACKGROUND

• Falco FJ, Datta S, Manchikanti L, Sehgal N, Geffert S, Singh V, Smith HS, Boswell MV. An updated review of the diagnostic utility of cervical facet joint injections. Pain Physician. 2012 Nov-Dec;15(6):E807-38.

  PMID: 23159977 BACKGROUND

• Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.

  PMID: 24482302 BACKGROUND

• Le ADK, Enweze L, DeBaun MR, Dragoo JL. Current Clinical Recommendations for Use of Platelet-Rich Plasma. Curr Rev Musculoskelet Med. 2018 Dec;11(4):624-634. doi: 10.1007/s12178-018-9527-7.

  PMID: 30353479 BACKGROUND

• Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302.

  PMID: 8929263 BACKGROUND

• MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.

  PMID: 22458772 BACKGROUND

• Manchikanti L, Hirsch JA, Kaye AD, Boswell MV. Cervical zygapophysial (facet) joint pain: effectiveness of interventional management strategies. Postgrad Med. 2016 Jan;128(1):54-68. doi: 10.1080/00325481.2016.1105092. Epub 2015 Dec 10.

  PMID: 26653406 BACKGROUND

• Persson M, Sorensen J, Gerdle B. Chronic Whiplash Associated Disorders (WAD): Responses to Nerve Blocks of Cervical Zygapophyseal Joints. Pain Med. 2016 Dec;17(12):2162-2175. doi: 10.1093/pm/pnw036. Epub 2016 Mar 27.

  PMID: 28025352 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Eldon Loh, MD

  St. Joseph's Healthcare London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants as well as the individuals collecting and analyzing outcome data will be blinded. The Primary Investigator, who is also the physician delivering the study compound, will not be blinded but will have no role in data collection or analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants who consent to study participation will be randomized to one of two groups: PRP injections, or corticosteroid injections.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 19, 2020
• Study Start: February 1, 2021
• Primary Completion: March 26, 2023
• Study Completion: August 15, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

CA (1)