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

NCT06715085 | Recruiting Phase 4 DMC

• 1 other identifier: BTIIMD-03-EC-23-DISC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diseases [C] - Musculoskeletal Diseases [C05

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life.

  Efficacy: evaluation of the Oswestry Disability Index (ODI) (also known as the Oswestry Low Back Pain Disability Questionnaire). 1\. Pain intensity / 2. Personal care (washing, dressing etc)/ 3. Lifting / 4. Walking /5. Sitting /6. Standing / 7.Sleeping /8. Sex life (if applicable)/9. Social life /10. Travelling For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) --\> 50 (total possible score) x 100 = 32% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement) 0% to 20%: minimal disability 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%: either bed-bound or exaggerating their symptoms

  6 moths follow up

Secondary Outcomes (1)

• Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7)

  1, 3, and 12 months follow-up

Other Outcomes (10)

• Evaluation of incidence and type of adverse events

  Up to 56 weeks

• Cost-effectiveness variables

  Up to 56 weeks

• Effectiveness variable

  Up to 56 weeks

Study Arms (2)

Experimental: Plasma Rich in Growth Factors (PRGF)

EXPERIMENTAL

The PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks.

Drug: Plasma Rich in Growth Factors (PRGF)

Control: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.

ACTIVE COMPARATOR

The corticosteroid solution application consists of two series of infiltrations of solution of corticosteroid (Celestone Cronodose injectable suspension \[betamethasone\]) and saline solution in the epidural space and in the facets, with a periodicity of one month between them.

Drug: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.

Interventions

Plasma Rich in Growth Factors (PRGF) DRUG

The PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks.

Also known as: PRGF injection

Experimental: Plasma Rich in Growth Factors (PRGF)

Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. DRUG

The corticosteroid solution application consists of two series of infiltrations of solution of corticosteroid (Celestone Cronodose injectable suspension \[betamethasone\]) and saline solution in the epidural space and in the facets, with a periodicity of one month between them.

Also known as: Corticosteroid solution

Control: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Biotechnology Institute IMASD: lead

Study Sites (1)

Clínica Eduardo Anitua

Vitoria-Gasteiz, Alava, 01005, Spain

RECRUITING

MeSH Terms

Interventions

Intercellular Signaling Peptides and Proteins; Injections

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Aitana Sainz

CONTACT

+34 653 31 75 17; aitana.sainz@bti-implant.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 4, 2024
• Study Start: January 23, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

ES (1)