Using Plasma Rich in Growth Factors to Treat Low Back Pain
Multicenter, Randomized, Single-blind, Controlled Clinical Trial to Evaluate the Safety and Efficacy of PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
This study is testing whether a treatment using Plasma Rich in Growth Factors can help people with low back pain from disc problems feel better compared to a standard corticosteroid solution.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotechnology Institute IMASD Industry-sponsored |
| Locations | 1 site (Vitoria-Gasteiz, Alava) |
| Trial ID | NCT06715085 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Plasma Rich in Growth Factors (PRGF) in alleviating low back pain and enhancing patients' quality of life. Participants will receive either PRGF or a control corticosteroid solution, and their pain levels will be assessed using a numerical pain scale. The study focuses on patients with lumbar intervertebral disc degeneration who have not found relief from previous drug treatments. The trial will compare outcomes between the two treatment groups to determine the efficacy of PRGF.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with MRI-confirmed lumbar intervertebral disc degeneration and chronic low back pain unresponsive to previous treatments.
Not a fit: Patients with low back pain not related to lumbar intervertebral disc degeneration or those who have not had symptoms for at least three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from chronic low back pain.
How similar studies have performed: Other studies have shown promising results with similar approaches using growth factor therapies for musculoskeletal conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vitoria-Gasteiz, Alava
- Clínica Eduardo Anitua — Vitoria-Gasteiz, Alava, Spain (Recruiting)
Study contacts
- Study coordinator: Aitana Sainz
- Email: aitana.sainz@bti-implant.es
- Phone: +34 653 31 75 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.