NCT04860531: PRP

The Role of Intra-articular Injection of PRP Versus Corticosteriods in Treatment of Lumbar Facet Disease

Completed Phase 3 Last updated 4 May 2021

What this trial tests

Phase 3 trial testing Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma in Lumbar Facet Joint Syndrome in 30 participants. Completed in 22 January 2021.

Timeline

17 September 2019

Primary endpoint
22 January 2021

22 January 2021

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	17 September 2019
Primary completion	22 January 2021
Estimated completion	22 January 2021
Sites	1 location across Egypt

Drugs / interventions tested

• Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma — full drug profile →
• Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone

Conditions studied

• Lumbar Facet Joint Syndrome — all drugs for Lumbar Facet Joint Syndrome →

Sponsor

Ain Shams University

Who can join

Adults 20 to 40, any sex, with Lumbar Facet Joint Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Low back pain is an extremely common health problem and recent studies have shown that nearly up to 52% of patients have low back pain caused by lumbar facet joint syndrome. Intra-articular injection of facet joints has gradually become one of the vital therapeutic methods for lumbar facet joint syndrome, Steroid is one of the most commonly used injected drugs; however, previous studies have indicated that it has limited ability in long-term relief of low back pain. Therefore, it seems meaningful to apply a new injectable drug and to prove its effectiveness and safety for the treatment of lumbar facet joint syndrome. Recent studies indicate that autologous platelet rich plasma(PRP) is an appropriate injectable material with great potential in treating many different musculoskeletal disorders and currently it is not yet used on a wide scale as a treatment for lumbar facet joint synovitis. In this study the investigators compare the efficacy and safety of Intra-articular injection of PRP versus conventional steriods in patients with lumbar facet joint synovitis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The role of intra-articular injection of autologous platelet-rich plasma versus corticosteroids in the treatment of synovitis in lumbar facet joint disease.
   Kotb SY, Sherif NM, Saleh HA, Ahmed SF, et al · · 2022 · cited 8× · PMID 36379530 · DOI 10.15537/smj.2022.43.11.20220449