A Phase 4 interventional study of Plasma Rich in Growth Factors (PRGF) and Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. in Diseases [C] - Musculoskeletal Diseases [C05, sponsored by Biotechnology Institute IMASD. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Biotechnology Institute IMASD · Phase 4, Interventional, and Treatment
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.
Biotechnology Institute IMASD is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks.
Drug: Plasma Rich in Growth Factors (PRGF)
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.
Drug: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.
The PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks.
Also known as: PRGF injection
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.
Also known as: Corticosteroid solution
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 up
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-up
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 weeks
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 year
Radiological imaging (MRI) results
Differences at 12 months with respect to baseline determinations of the size of the disc herniation.
Time frame: 1 year
Radiological imaging (MRI) results
Differences at 12 months with respect to baseline determinations of the Intervertebral space height (endplate to endplace).
Time frame: 1 year
Radiological imaging (MRI) results
Differences at 12 months with respect to baseline determinations of the disc volume.
Time frame: 1 year
Started Jan 2025 (actual). Primary completion is estimated for Feb 2026, 12 months after the start.
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Biotechnology Institute IMASD