Multicenter, Randomized, Single-blind, Controlled Clinical Trial to Evaluate the Safety and Efficacy of PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-S
- •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.
- •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.
研究组 & 干预措施
Experimental: Plasma Rich in Growth Factors (PRGF)
The PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks.
干预措施: Plasma Rich in Growth Factors (PRGF) (Drug)
Control: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.
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.
干预措施: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. (Drug)
结局指标
主要结局
To evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life.
时间窗: 6 moths follow up
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
次要结局
- 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)