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Study on the Use of Platelet Concentrate and Betamethasone for Treating Chronic Low Back Pain in Patients with Lumbar Disc Degeneration

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of low back pain, a common condition that affects the lower part of the spine. The study will evaluate the effectiveness of a treatment called PRGF-Endoret®, which involves using plasma rich in growth factors. This plasma is derived from blood and is thought to help reduce pain and improve the quality of life for patients with chronic low back pain due to disc degeneration in the lumbar spine. The trial will compare this treatment to a more conventional approach using Celestone Cronodose, which contains the active substances betamethasone acetate and betamethasone sodium phosphate, commonly used as corticosteroids to relieve pain and inflammation.

The purpose of the study is to determine how well PRGF-Endoret® works in reducing pain and improving life quality over a period of six months. Participants will receive either the plasma treatment or the conventional corticosteroid treatment through an injection into the epidural space, which is the area around the spinal cord. The study will follow participants for up to 12 months to monitor their progress and any changes in their condition.

Throughout the study, various assessments will be conducted, including the use of the Oswestry Scale, which measures the impact of back pain on daily activities. Other evaluations will include the COMI scale and the SF-12 scale, which are tools used to assess pain and overall health status. Additionally, MRI scans will be used to observe any changes in the spine, and the study will also track any side effects or adverse events that may occur. The trial aims to provide valuable insights into the potential benefits of using plasma rich in growth factors for treating low back pain.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have a diagnosis of lumbar intervertebral disc degeneration confirmed by an MRI scan.

    The patient must have experienced low back pain for at least three months that has not improved with medication.

    The patient must provide a signed informed consent to participate in the trial and agree to data processing for scientific publication.

  2. Step 2

    Initial assessment

    The patient undergoes a complete blood test, including hemogram, basic biochemistry, and coagulation tests, performed within the last two months.

    The patient completes a numerical pain scale assessment, with scores between 6 and 10, averaged over the last month.

  3. Step 3

    Treatment administration

    The patient receives injections of PRGF-Endoret® or conventional corticosteroid and anesthetic treatment.

    The injections are administered via epidural use.

  4. Step 4

    Follow-up assessments

    The patient's progress is evaluated using the Oswestry scale at 1, 3, 6, and 12 months.

    Additional assessments include the COMI scale and SF-12 scale at 1, 3, 6, and 12 months.

    MRI scans are conducted to assess changes in disc degeneration at 12 months.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the evaluation of the Oswestry scale at 6 months.

    Secondary outcomes include the percentage of treatment failures and the incidence of adverse events.

    A cost-utility analysis and hematological and biochemical characterization of blood and PRGF are also conducted.

Who can join the trial?

9 criteria

  • Patients must be of legal age, which means they should be **18 years or older**.
  • Patients need to have a diagnosis of **lumbar intervertebral disc degeneration**. This is confirmed by a test called **Magnetic Resonance Imaging (MRI)**, and the degeneration should be more than level 1 on the **Pfirrmann Scale**.
  • Patients should have positive signs in the MRI at the **L4-L5** and/or **L5-S1** levels. This includes issues like a **rupture of the annulus fibrosus** or an **annular fissure**, with or without a disc bulge known as **disc herniation**.
  • Patients must have been experiencing **low back pain** for at least **3 months** that has not improved with medication.
  • Their pain level should be between **6 and 10** on a **numerical pain scale** called the **COMI PAIN SCORE**, based on the average of the last month.
  • Patients need to have an **MRI** done in the last **six months** to confirm the diagnosis.
  • A **complete blood test** (including hemogram, basic biochemistry, and coagulation tests) should have been done in the last **two months**.
  • Patients must sign an **informed consent** form to participate in the trial and agree to the use of their data for scientific purposes.
  • Patients should agree in the informed consent to be available for follow-up after treatment for up to **12 months**.

Who cannot join the trial?

10 criteria

  • Patients who have had recent surgery on their lower back.
  • Individuals with a history of severe allergic reactions to medications.
  • People who are currently participating in another clinical trial.
  • Patients with certain infections or diseases that affect the immune system.
  • Individuals who are pregnant or breastfeeding.
  • People with a history of drug or alcohol abuse.
  • Patients with severe mental health conditions that might affect their ability to participate.
  • Individuals with certain heart conditions that could be worsened by the treatment.
  • People who have had a recent injury to their lower back.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
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Investigated drugs

  • PRGF-Endoret®

    is a treatment that involves using plasma rich in growth factors. This therapy is designed to help reduce pain and improve the quality of life for patients suffering from low back pain due to disc degeneration. The growth factors in the plasma are believed to promote healing and tissue regeneration, which may alleviate pain and improve function in the affected area.

  • Corticosteroids

    are medications that help reduce inflammation and pain. In this trial, they are used as a conventional treatment option for patients with low back pain. By decreasing inflammation, corticosteroids can provide relief from pain and improve mobility.

  • Anesthetics

    are used to numb the area and provide pain relief. In this trial, anesthetics are part of the conventional treatment approach for managing low back pain. They work by blocking nerve signals in the affected area, which helps to reduce pain sensations.

What is already known about the treatment

PRGF-Endoret® – This medication is administered through injections directly into the affected area of the lower back. It is currently being studied in clinical trials to assess its effectiveness and safety for treating low back pain, particularly in cases involving disc degeneration in the lumbar spine. The main therapeutic indication is to reduce pain and improve the quality of life for patients suffering from chronic low back pain. PRGF-Endoret® works by utilizing plasma rich in growth factors, which are believed to promote tissue repair and reduce inflammation at the molecular level. It is classified under regenerative medicine therapies.

Investigated diseases

Low Back Pain – Low back pain is a common condition characterized by discomfort or pain in the lower back area. It can result from various causes, including muscle strain, ligament sprain, or disc degeneration. The pain may be acute, lasting a few days to weeks, or chronic, persisting for more than three months. It often affects mobility and can interfere with daily activities. The condition may be accompanied by stiffness, muscle spasms, or a limited range of motion. In some cases, the pain may radiate to the legs, indicating nerve involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507429-41-00Protocol codeBTIIMD-03-EC-23-DISCEstimated enrolment48 patientsSponsorBiotechnology Institute I Mas D S.L.

sourced from the EU Clinical Trials Register and site verification

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