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

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What is this study about?

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.

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 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 treatment administration

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

The injections are administered via epidural use.

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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ccqitxg Erfeiju Ajwfce	Vitoria	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.09.2024

Trial locations

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.

Investigated Diseases:

Back pain

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 ID:

2023-507429-41-00

Protocol code:

BTIIMD-03-EC-23-DISC

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?