Diseases [C] - Musculoskeletal Diseases [C05Phase 4NCT06715085
PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
A Phase 4 study testing Plasma Rich in Growth Factors (PRGF) and Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. in people with Diseases [C] - Musculoskeletal Diseases [C05, run by Biotechnology Institute IMASD at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diseases [C] - Musculoskeletal Diseases [C05
- What is being tested?
- Plasma Rich in Growth Factors (PRGF) and Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2025to 1 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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 1.1.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clínica Eduardo Anitua
Vitoria-Gasteiz, Alava, 01005
Aitana Sainz, +35653317517, aitana.sainz@bti-implant.es
About this study
Official title: Multicenter, Randomized, Single-blind, Controlled Clinical Trial to Evaluate the Safety and Efficacy of PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
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.
- Being tested
- Plasma Rich in Growth Factors (PRGF), Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma Rich in Growth Factors (PRGF)Drug
Also called PRGF injection
The 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.Drug
Also called Corticosteroid 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Plasma Rich in Growth Factors (PRGF) |
| 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. Receives: Drug: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
- 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
Measured: 6 moths follow up
Secondary 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
Measured: 1, 3, and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start23 Jan 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases [C] - Musculoskeletal Diseases [C05Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotechnology Institute IMASD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715085
- Sponsor's protocol ID
- BTIIMD-03-EC-23-DISC
- Status last verified
- Feb 2025
- First submitted
- 21 Nov 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Single-blind, Controlled Clinical Trial to Evaluate the Safety and Efficacy of PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.
- ClinicalTrials.gov ID
- NCT06715085
- Acronym / sponsor ID
- BTIIMD-03-EC-23-DISC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Biotechnology Institute IMASDIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Plasma Rich in Growth Factors (PRGF) | Experimental | Drug: 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. |
| Control: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Patients with neurogenic motor claudication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma Rich in Growth Factors (PRGF)Also: PRGF injectionThe PRGF application consists of three series of infiltrations in the intervertebral disc, epidural space and facets, with a frequency of two weeks. | Drug | Experimental: Plasma Rich in Growth Factors (PRGF) |
| Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution.Also: Corticosteroid solutionThe 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 | Control: Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. |
Primary outcome
To evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life.
Time frame: 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
1 secondary outcome
Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7)
Time frame: 1, 3, and 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasma Rich in Growth Factors (PRGF) and Corticosteroid solution (Celestone Cronodose suspension for injection) in saline solution. in people with Diseases [C] - Musculoskeletal Diseases [C05, run by Biotechnology Institute IMASD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aitana Sainz (+34 653 31 75 17, aitana.sainz@bti-implant.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life. (time frame: 6 moths follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.