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

Launched by BIOTECHNOLOGY INSTITUTE IMASD · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called PRGF (Plasma Rich in Growth Factors) to see if it can help reduce low back pain and improve the quality of life for patients who have not found relief from other medications. The researchers will compare the effectiveness of PRGF to a standard treatment, which is a corticosteroid solution mixed with saline. The trial is currently looking for participants aged 18 and older who have been diagnosed with certain types of lower back issues through an MRI and have experienced pain for at least three months.

To be eligible, participants should have moderate to severe back pain (rated between 6 and 10 on a pain scale) and must have had an MRI within the last six months. However, individuals with specific conditions, such as severe disc problems, previous back surgery, or certain health issues like severe cardiovascular disease or active infections, cannot participate. Those who join the study can expect to receive either the experimental treatment or the standard treatment, and they will be closely monitored to assess their pain levels and overall health improvements throughout the trial. It's important for potential participants to understand that they will need to provide informed consent and meet the study's health criteria to take part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of legal age (≥18 years).
• • Patients diagnosed by Magnetic Resonance Imaging (MRI) with lumbar intervertebral disc degeneration(s) (Pfirrmann Scale \> 1).Patients with positive signs in MRI at L4-L5 and/or L5-S1 levels, including rupture of the annulus fibrosus, annular fissure, 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 of evolution 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 coagulation tests) performed in the last two months.
• • Signed informed consent to participate in the clinical trial and authorization for data processing by the different centers involved for subsequent scientific publication.
• Exclusion Criteria:
• • Patients with lumbar fracture, extruded herniated discs and herniated discs with signs 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 illness or 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 not taking effective contraceptive measures as outlined in the Clinical Trials Facilitation and Coordination Group (CTFG) "Recommendations Regarding Contraception and Pregnancy Testing in Clinical Trials" V 1.1.
• • Patients with pathologies that produce marked alterations in the efficacy of PRGF or coagulation, such as, for example: poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%), hematological alterations (thrombopathy, thrombopenia, anemia with Hb \< 9), being subjected to immunosuppressive and/or dicoumarinic treatments, or any treatment with systemic corticosteroids during the 6 months prior to inclusion 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.