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Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction

NCT04757740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-07-09

No results posted yet for this study

Summary

Low back pain is one of the commonest complaints nowadays affecting nearly 20% of the population, Sacroiliac joint has been accused of being the primary cause of pain in about 10%: 27% of this population.

The sure diagnosis of sacroiliac joint pain is challenging because of multiple crossed factors of facet joint pain and intervertebral disc pain. Diagnosis can be done by history taking, local examination, imaging techniques, and controlled local anesthetic blocks.

Controlled local anesthetic blocks are diagnostic and therapeutic done by various methods either landmark-guided or imaging-assisted either by fluoroscopy, computed tomography (CT), magnetic resonance (MRI), or ultrasound-guided.

Lower cost, real-time viewing of needle leading to higher accuracy rate, and low ionizing radiation dose are favoring ultrasound-guided injection over other modalities.

Numerous treatment modalities are being used for sacroiliac joint pain ranging from physiotherapy and systemic analgesics like Non-steroidal anti-inflammatory drugs (NSAIDs) to minimally invasive intra-articular, periarticular injection, radiofrequency neurotomy, and surgical fusion of the joint.

Multiple injectates are being used for intraarticular injection most commonly local anesthetics and steroids which offer short-term symptomatic relief and delay the degenerative process.

The need for a longer duration effect directly affects the disease process itself aiming for accelerating the joint healing rate by biological growth factors found in human blood especially in platelets.

Platelet-rich plasma (PRP) has been used aiming to inject a high concentration of growth factors directly into the joint.

Platelet-rich fibrin (PRF), the second generation of platelet-rich plasma is now tried having the advantage of a simpler preparation and higher values of growth factors.

Conditions

  • Low Back Pain

Interventions

BIOLOGICAL

intra-articular Platelet rich fibrin and lidocaine

intra-articular injection of 3.5 ml of 1% lidocaine and PRF mixture.

DRUG

methylprednisolone acetate and lidocaine

intra-articular injection of Mixture of 40 mg of methylprednisolone acetate(1 ml) and 1% lidocaine (2.5 ml). intra-articular steroid

Sponsors & Collaborators

  • Fayoum University Hospital

    lead OTHER

Principal Investigators

  • Mohamed A Alsaeid, MD · Fayoum University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-09-01
Completion
2023-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04757740 on ClinicalTrials.gov