Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06715085

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

Led by Biotechnology Institute IMASD · Updated on 2025-02-06

48

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Diagnosed with lumbar intervertebral disc degeneration by MRI (Pfirrmann Scale > 1)
  • Positive MRI signs at L4-L5 and/or L5-S1 levels, including annulus fibrosus rupture or fissure, with or without disc herniation in protrusion form
  • Low back pain symptoms for at least 3 months not responding to drug treatment
  • Pain score between 6 and 10 on the COMI Pain Scale averaged over the last month
  • MRI performed within the last 6 months
  • Complete blood test performed within the last 2 months
  • Signed informed consent for participation and data use
Not Eligible

You will not qualify if you...

  • Lumbar fracture, extruded herniated discs, or herniated discs with calcification signs
  • Severe discopathies adjacent to L4-L5 and/or L5-S1
  • Previous spinal surgery
  • Invasive spine procedures in the past 6 months (infiltrations, blocks, lavage, lumbar rhizolysis)
  • Neurogenic motor claudication
  • Severe cardiovascular, central nervous system diseases, epilepsy, coagulopathies, immunological or infectious diseases, cancer, or neurodegenerative diseases
  • History of drug use disorders or significant psychological conditions related to pain
  • Morbid obesity (BMI > 40 kg/m2)
  • Pregnancy, breastfeeding, or ineffective contraception in women of childbearing age
  • Conditions affecting PRGF efficacy or coagulation, such as poorly controlled diabetes, hematological disorders, immunosuppressive or dicoumarinic treatments, or recent systemic corticosteroid use
  • Allergy to sedation components or corticosteroids
  • Previous PRGF back treatment in the last 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clínica Eduardo Anitua

Vitoria-Gasteiz, Alava, Spain, 01005

Actively Recruiting

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Research Team

A

Aitana Sainz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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