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

Last updated: February 4, 2025
Sponsor: Biotechnology Institute IMASD
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Pain

Musculoskeletal Diseases

Treatment

Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.

Plasma Rich in Growth Factors (PRGF)

Clinical Study ID

NCT06715085
BTIIMD-03-EC-23-DISC
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of legal age (≥18 years).

  • Patients diagnosed by Magnetic Resonance Imaging (MRI) with lumbar intervertebraldisc degeneration(s) (Pfirrmann Scale > 1).Patients with positive signs in MRI atL4-L5 and/or L5-S1 levels, including rupture of the annulus fibrosus, annularfissure, with or without disc herniation in its protrusion form will be included.

  • Patients with low back pain with symptoms of low back pain for at least 3 months ofevolution that has not responded to drug treatment.

  • Numerical pain scale (COMI PAIN SCORE): between 6 and 10, average of the last month.

  • Availability of an MRI performed in the last six months to allow the diagnosis.

  • Availability of a complete blood test (hemogram, basic biochemistry and coagulationtests) performed in the last two months.

  • Signed informed consent to participate in the clinical trial and authorization fordata processing by the different centers involved for subsequent scientificpublication.

Exclusion

Exclusion Criteria:

  • Patients with lumbar fracture, extruded herniated discs and herniated discs withsigns of calcification are excluded.

  • Patients with severe discopathies at levels adjacent to L4-L5 and/or L5-S1.

  • Patients who have previously undergone spinal surgery.

  • Patients who have undergone invasive procedures on the spine in the last 6 months,such as infiltrations, blocks, lavage or lumbar rhizolysis.

  • Patients with neurogenic motor claudication.

  • Patients with severe cardiovascular diseases, central nervous system diseases,epilepsy, coagulopathies, immunological diseases, infectious diseases (e.g.Hepatitis B and C, HIV, Syphilis), cancer or neurodegenerative pathologies.

  • Patients with a history of drug use (e.g. alcoholism or others) and mental illnessor marked psychological conditions related to pain.

  • Morbidly obese patients (BMI > 40 kg/m2).

  • Women who are pregnant or breastfeeding or women of childbearing age who are nottaking effective contraceptive measures as outlined in the Clinical TrialsFacilitation and Coordination Group (CTFG) "Recommendations Regarding Contraceptionand Pregnancy Testing in Clinical Trials" V 1.1.

  • Patients with pathologies that produce marked alterations in the efficacy of PRGF orcoagulation, such as, for example: poorly controlled diabetes mellitus (glycosylatedhemoglobin above 9%), hematological alterations (thrombopathy, thrombopenia, anemiawith Hb < 9), being subjected to immunosuppressive and/or dicoumarinic treatments,or any treatment with systemic corticosteroids during the 6 months prior toinclusion in the study

  • Patients who present allergy to any component of the sedation or to the corticoid.

  • Patients who have received previous back treatment with PRGF in the last 6 months.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.
Phase: 4
Study Start date:
January 23, 2025
Estimated Completion Date:
February 01, 2027

Connect with a study center

  • Clínica Eduardo Anitua

    Vitoria, Alava 01005
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.