Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients With Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections

NCT05188820 | Completed

• 1 other identifier: 21.246
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients with Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections: A Triple Blinded Randomized Controlled Trial.

Conditions

Low Back Pain; Platelet Rich Plasma; Zygapophyseal Joint Arthritis

Keywords

low back pain; platelet rich plasma; Zygapophyseal Joint Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in visual analogue scale (VAS)

  visual analogue scale of pain scale from 0-10 (higher is worse)

  0, 3, 9, 12 months

Secondary Outcomes (3)

• Change in Oswestry low back disability index

  0, 3, 9, 12 months

• Change in Short Form 36 scale

  0, 3, 9, 12 months

• Change in Modified McNabb scale

  0, 3, 9, 12 months

Study Arms (2)

Corticosteroid group

ACTIVE COMPARATOR

Patients will receive intra-articular z-joint injection of cortisone

Procedure: Cortisone injection

PRP group

EXPERIMENTAL

Patients will receive intra-articular z-joint injection of PRP

Procedure: PRP - platelet rich plasma injection

Interventions

PRP - platelet rich plasma injection PROCEDURE

Facet block using PRP

PRP group

Cortisone injection PROCEDURE

Facet block using cortisone

Corticosteroid group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 40 years old or more; given the low prevalence of facet pain in younger adults
• LBP present for more than six months, with an axial predominance
• Persistent LBP after three months of non-interventional treatment
• Pretreatment ODI score of at least 30/100 (moderate disability associated with LBP)
• Pretreatment LBP VAS of at least 4/10
• % LBP reduction 30 minutes after 2 intra-articular diagnostic blocs with Xylocaine and Marcaine
• Radiological signs of facet joint degeneration (on X-rays, CT Scan or MRI)
• Absence of neurological deficit
• Sufficient knowledge of French or English to complete the questionnaires

You may not qualify if:

• \- Less than 40 years old
• Failure to achieve intra-articular diagnostic block
• Intra-articular injection of CS 3 months or less before recruitment
• Oral corticosteroid use in the last two weeks
• Inflammatory disease
• Systemic infection
• Infection at injection site
• Vertebral fracture
• Spine tumour
• Surgical intervention at injection site prior to the study or planned
• Cognitive disorder that impairs the ability to answer the questionnaires
• Pregnancy
• Breastfeeding
• Coagulopathy affecting platelets
• Drug affecting platelets that cannot be stopped (except acetylsalicylic acid)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Spine Intervention Society: collaborator
• Association Québécoise Médecine Sportive et Exercice: collaborator

Study Sites (1)

Centre Hopsitalier Université de Montreal

Montreal, Quebec, Canada

Location

Related Publications (1)

• Cauchon AM, Mares C, Fan XY, Bois MC, Hagemeister N, Noiseux N, Roy A. Comparing the efficacy of intra-articular injection of Platelet Rich Plasma (PRP) with corticosteroids (CS) in patients with chronic zygapophyseal joint low back pain confirmed by double intra-articular diagnostic blocks: A triple-blinded randomized multicentric controlled trial with a 6-month follow-up. Interv Pain Med. 2024 Dec 3;3(4):100525. doi: 10.1016/j.inpm.2024.100525. eCollection 2024 Dec.

  PMID: 39717452 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Cortisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design: Triple-blinded randomized controlled trial Patient Sample: Fifty participants with radiological signs of osteoarthritis and Z-Joint LBP confirmed by dual intra-articular local anesthetic injections will be recruited and randomized in two groups: CS and LP-PRP injection groups.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 12, 2022
• Study Start: April 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CA (1)