PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotechnology Institute IMASD
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Plasma Rich in Growth Factors (PRGF)
- Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov