Clinical trial NCT06715085: PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
Official title: Multicenter, Randomized, Single-blind, Controlled Clinical Trial to Evaluate the Safety and Efficacy of PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diseases [C] - Musculoskeletal Diseases [C05
Lead sponsor: Biotechnology Institute IMASD
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: To evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life.
timeFrame: 6 moths follow up
Secondary outcomes:
measure: Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7)
timeFrame: 1, 3, and 12 months follow-up
Other outcomes:
measure: Evaluation of incidence and type of adverse events
timeFrame: Up to 56 weeks
measure: Cost-effectiveness variables
timeFrame: Up to 56 weeks
measure: Effectiveness variable
timeFrame: Up to 56 weeks
measure: Evaluation of the COMI scale.
timeFrame: 1 , 3, and 12 months of follow-up
measure: Evaluation of the SF-12 scale
timeFrame: 1, 3, 6 and 12 moths follow up
measure: Evaluation of the EQ-5D-5L Survey
timeFrame: 1, 3, 6 and 12 moths follow up
measure: Radiological imaging (MRI) results
timeFrame: 1 year
measure: Radiological imaging (MRI) results
timeFrame: 1 year
measure: Radiological imaging (MRI) results
timeFrame: 1 year
measure: Radiological imaging (MRI) results
timeFrame: 1 year
Locations:
city: Vitoria
country: Spain
facility: Clínica Eduardo Anitua
state: Alava
Study officials:
References: