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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7) | Percentage of treatment failures at 1, 3, and 12 months follow-up | 1, 3, and 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of incidence and type of adverse events | Safety variables: each of the adverse events will be described, with a frequency analysis of the safety variables by treatment group, and a subsequent comparison of these by means of the chi-square test. | Up to 56 weeks |
| Cost-effectiveness variables |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aitana Sainz | Contact | +34 653 31 75 17 | aitana.sainz@bti-implant.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Eduardo Anitua | Recruiting | Vitoria-Gasteiz | Alava | 01005 | Spain |
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D007267 | Injections |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| 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. |
|
|
Incremental Cost-Effectiveness Ratio (ICER). The two arms of the trial will be compared to estimate the ICER. Costs will be calculated at the individual level and prospectively. |
| Up to 56 weeks |
| Effectiveness variable | As a measure of effectiveness, quality of life adjusted life years (QoLs) will be calculated as a function of the duration measured by the study and the EuroQol values obtained before and at 56 weeks. | Up to 56 weeks |
| Evaluation of the COMI scale. | Evaluation of the Core Outcome Measures Index (COMI) scale. It is scored from 0 to 10, the lower the score, the better the result. | 1 , 3, and 12 months of follow-up |
| Evaluation of the SF-12 scale | SF-12 Health Survey. This survey asks for the views about health. The result obtained depends on an algorithm. From the physical domain of the scale, the best result is 56.57 and the worst, 23.99. From the mental domain of the scale, the best result is 60.75 and the worst 19.06. | 1, 3, 6 and 12 moths follow up |
| Evaluation of the EQ-5D-5L Survey | To assess the quality of life (EQ-5D-5L survey) related to health or perceived health (in its two aspects, physical and mental). Score from 0 to 100 with 100 being the best result in terms of health. | 1, 3, 6 and 12 moths follow up |
| Radiological imaging (MRI) results | Differences at 12 months with respect to baseline determinations of the Pfirrmann grade | 1 year |
| Radiological imaging (MRI) results | Differences at 12 months with respect to baseline determinations of the size of the disc herniation. | 1 year |
| Radiological imaging (MRI) results | Differences at 12 months with respect to baseline determinations of the Intervertebral space height (endplate to endplace). | 1 year |
| Radiological imaging (MRI) results | Differences at 12 months with respect to baseline determinations of the disc volume. | 1 year |
| D004333 |
| Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |