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

NCT06715085 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Biotechnology Institute IMASD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-23
Primary Completion
2026-02-01
Completion
2027-02-01

Countries

  • Spain

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 NCT06715085 on ClinicalTrials.gov