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Multicenter, randomized and controlled clinical trial to evaluate the use of PRGF-Endoret® in the treatment of low back pain
EU CTIS ID: 2023-507429-41-00
What this study is testing
The main objective of this clinical trial is to evaluate the efficacy of PRGF in reducing pain and improving quality of life (Oswestry Scale) in patients with disc degeneration in the lumbar spine with chronic clinical manifestation, compared to conventional corticosteroid treatment at six months follow-up.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Patients with lumbar fracture, extruded herniated discs and herniated discs with signs of calcification are excluded.
- 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 and/or anesthetic.
- Patients with severe discopathies at levels adjacent to L4-L5 and/or L5-S1.
- Patients who have previously undergone spinal surgery.
- Patients with neurogenic motor claudication.
See the full eligibility 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.
- Commitment in the informed consent of availability for post-treatment patient follow-up (up to 12 months).
- Patients with lumbar fracture, extruded herniated discs and herniated discs with signs of calcification are excluded.
- 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 and/or anesthetic.
- Patients with severe discopathies at levels adjacent to L4-L5 and/or L5-S1.
- Patients who have previously undergone spinal surgery.
- 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 who have undergone invasive procedures on the spine in the last 6 months, such as infiltrations, blocks, lavage or lumbar rhizolysis.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.