Evaluation of the Efficacy and Safety of Platelet Concentrate Versus Betamethasone Acetate and Betamethasone Sodium Phosphate in Chronic Low Back Pain

The primary objective of this clinical trial is to evaluate the **efficacy** of Plasma Rich in Growth Factors (PRGF) in reducing pain and improving quality of life, as measured by the Oswestry Disability Index, in patients with disc degeneration in the lumbar spine with chronic clinical manifestation. This is compared to conventional corticosteroid treatment at a six-month follow-up. This objective is clinically relevant as it addresses the potential of PRGF as an alternative treatment for low back pain, which is a prevalent condition with significant impact on patient quality of life and healthcare resources.

Secondary objectives include:

• Evaluating the efficacy of PRGF in reducing pain and improving quality of life using the Oswestry Scale and COMI scale at 1, 3, 6, and 12 months follow-up compared to conventional treatment.
• Assessing the quality of life related to health or perceived health using the SF-12 questionnaire in its physical and mental aspects at 1, 3, 6, and 12 months follow-up.
• Determining structural changes via MRI related to clinical improvement in the PRGF group versus the control group at 12 months post-treatment.
• Assessing the safety profile of PRGF infiltrations.
• Evaluating the cost-effectiveness of PRGF treatment compared to conventional treatment.
• Identifying biological variables and biochemical markers that correlate with the clinical efficacy of PRGF treatment.

The clinical trial focuses on evaluating the efficacy of PRGF in patients with **low back pain** due to lumbar intervertebral disc degeneration. The study population includes both male and female participants of legal age, specifically those aged 18 years and older. Participants are required to have a diagnosis confirmed by Magnetic Resonance Imaging (MRI) showing lumbar disc degeneration, with specific signs at the L4-L5 and/or L5-S1 levels. The trial does not involve a vulnerable population. Participants must have experienced symptoms of low back pain for at least three months that have not responded to drug treatment, with a numerical pain scale score between 6 and 10. The sponsor has not provided the total number of participants. Lifestyle considerations such as diet and physical activity are not specified. Key inclusion criteria include the availability of recent MRI and blood test results, as well as a commitment to follow-up for up to 12 months post-treatment. The trial does not specify any exclusion criteria in the provided data.

The clinical trial is designed as a **randomized**, **double-blind**, and controlled study to evaluate the safety and efficacy of PRGF-Endoret® infiltrations in the treatment of **low back pain**. The trial aims to compare the efficacy of PRGF in reducing pain and improving quality of life, as measured by the Oswestry Scale, in patients with lumbar spine disc degeneration, against conventional corticosteroid treatment over a six-month follow-up period. The trial is expected to commence recruitment on September 2, 2024, and conclude by August 2, 2027.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥18 years), MRI-confirmed lumbar intervertebral disc degeneration, and persistent low back pain for at least three months. Following the screening, eligible participants will be randomized to receive either the investigational product, **Plasma rich in growth factors**, or the comparator, **Celestone Cronodose suspension for injection**, both administered via epidural use. The maximum treatment period for each product is two weeks.

Subsequent follow-up visits are scheduled at 1, 3, 6, and 12 months post-treatment to assess primary and secondary endpoints, including the Oswestry scale, COMI scale, SF-12 scale, and radiological imaging results. The primary endpoint is the evaluation of the Oswestry scale at six months, while secondary endpoints include treatment failure rates, adverse events, and cost-utility analysis. The end-of-study visit will occur at the 12-month mark, concluding the participant's involvement in the trial.

Participant involvement is expected to last up to 12 months, with conditions for early termination including withdrawal of consent, non-compliance with the study protocol, or the occurrence of adverse events that compromise participant safety. The trial is classified as a low-intervention study, adhering to regulatory standards and ensuring minimal additional risk compared to standard clinical practice.

The clinical trial involves the administration of two treatments to evaluate their efficacy and safety in the management of low back pain associated with disc degeneration. The **experimental medication** is "Plasma rich in growth factors," which is an **injectable** form containing the active substance **platelet concentrate**. This substance is derived from blood and is classified as a structurally diverse substance. The administration route is **epidural use**, with a maximum daily dose of 24 ml and a total maximum dose of 72 ml over a treatment period of up to 2 weeks. The product is manufactured by Biotechnology Institute I Mas D S.L. and is not a pediatric formulation.

The **comparator treatment** in this trial is "Celestone Cronodose suspensión inyectable," which is a **suspension for injection** containing the active substances **betamethasone acetate** and **betamethasone sodium phosphate**. These substances are of chemical origin and are used for their corticosteroid properties. The administration is also via **epidural use**, with a maximum daily dose of 28.5 mg and a total maximum dose of 57 mg over a treatment period of up to 2 weeks. This product is manufactured by Organonsalud, S.L. and is utilized in the daily clinical practice of the recruiting hospital for treating the condition under evaluation.

Both treatments are administered under controlled conditions, and participant compliance is monitored throughout the trial. The trial is designed to be multicenter, randomized, double-blind, and controlled, ensuring rigorous assessment of the treatments' efficacy in reducing pain and improving the quality of life in patients with chronic lumbar spine disc degeneration.

The efficacy of the investigational treatment in this clinical trial will be assessed primarily through the evaluation of the Oswestry Disability Index (ODI) at a six-month follow-up. This index is a widely recognized tool for measuring the degree of disability and quality of life in patients with low back pain. Secondary endpoints include the percentage of treatment failures at 1, 3, and 12 months, as well as further assessments of the Oswestry scale at these timepoints. Additional efficacy evaluations will involve the COMI scale and the SF-12 scale at 1, 3, 6, and 12 months, which are also established measures for assessing pain and quality of life.

Radiological imaging, specifically Magnetic Resonance Imaging (MRI), will be used to assess changes at 12 months compared to baseline in terms of the **Pfirrmann** grade, size of disc herniation, intervertebral space height, and disc volume. The trial will also monitor the incidence and type of adverse events, conduct a cost-utility analysis, and perform hematological and biochemical characterizations of blood and PRGF. These assessments will provide a comprehensive evaluation of the treatment's efficacy in reducing pain and improving the quality of life in patients with lumbar disc degeneration.