NCT06715085

PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.

Multicenter, Randomized, Single-blind, Controlled Clinical Trial to Evaluate the Safety and Efficacy of PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Biotechnology Institute IMASD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life. Researchers will compare an experimental drug (Plasma Rich in Growth Factors) to a control corticosteroid solution in saline solution.

Conditions

• Diseases [C] - Musculoskeletal Diseases [C05

Interventions

Type	Name	Description
DRUG	Plasma Rich in Growth Factors (PRGF)	The PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks.
DRUG	Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.	The corticosteroid solution application consists of two series of infiltrations of solution of corticosteroid (Celestone Cronodose injectable suspension \[betamethasone\]) and saline solution in the epidural space and in the facets, with a periodicity of one month between them.

Timeline

• Start date: 2025-01-23
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2024-12-04
• Last updated: 2025-02-06

Locations

1 site across 1 country: Spain