PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotechnology Institute IMASD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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-S1.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Plasma Rich in Growth Factors (PRGF)
DrugThe PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks.
Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.
DrugThe 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Experimental: Plasma Rich in Growth Factors (PRGF)Experimental treatment 1 intervention
Group B: Control: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
6 moths follow upSecondary outcomes
1
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
Time frame
1, 3, and 12 months follow-upOther outcomes
1
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.
Time frame
Up to 56 weeks2
Cost-effectiveness variables
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.
Time frame
Up to 56 weeks3
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.
Time frame
Up to 56 weeks4
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.
Time frame
1 , 3, and 12 months of follow-upSponsors and contacts
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Source ClinicalTrials.gov