Chronic PainPhase 3NCT07448285
Clinical Trial to Evaluate the Efficacy and Safety of Platelet-rich Plasma Infiltration in Chronic Omalgia
A Phase 3 study testing Platelet-rich Plasma Local injection and betamethasone and Ropivacaine in people with Chronic Pain, run by Biobizkaia Health Research Institute at 2 sites in Spain.
Trial summary
The experimental group will receive intralesional injections of platelet-rich plasma, evaluating its ability to relieve pain and provide sustained improvement through biological modulation of the joint and tendon environment. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Platelet-rich Plasma Local injection and betamethasone and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesSpain
- Study dates
- 24 Feb 2026to Apr 2029
- Phase
- Phase 3
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 35 and 75 years of age, both inclusive.
- Presence of pain in the affected shoulder for 3 or more months.
- Body Mass Index (BMI) values between 20 and 27 kg/m2, including both values.
- Confirmed diagnosis of chronic shoulder pain associated with rotator cuff tendinopathy, following an unfavorable response to standard treatment with analgesics and nonsteroidal anti-inflammatory drugs for 4-6 weeks.
- Patients who agree to participate in the study and sign the informed consent form.
Who cannot join
- Confirmed diagnosis of complete rotator cuff tear.
- Patients with systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
- Patients with diabetes mellitus.
- Patients with hematological disorders (thrombopathy, thrombocytopenia, anemia with Hb<9 g/dl).
- Patients undergoing immunosuppressive treatment at the time of inclusion.
- Patients undergoing treatment with intramuscular corticosteroids in the 3 months prior to the first administration of the trial treatment.
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- Patients undergoing treatment with nonsteroidal anti-inflammatory drugs (more than 10 consecutive days at usual doses), opioids, or oral corticosteroids during the 15 days prior to treatment in the study.
- Patients with severe heart disease.
- Patients with active cancer or cancer diagnosed in the last 5 years.
- Patients who are taking a drug in clinical trials or have participated in any clinical trial (with an authorized or unauthorized product) in the 30 days prior to randomization.
- Patients with any physical, social, or psychological condition that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained from their participation in it.
- Pregnant women.
- Breastfeeding women.
- Women of childbearing age* who are unable or unwilling to use contraceptive methods with a failure rate of <1% per year (bilateral tubal ligation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the four-week treatment period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Cruces
Barakaldo, Bizkaia, 48903
Juan Ignacio Reoyo, doctor, 34 946006000, uiceecc.regulatoria@bio-bizkaia.eus
- Not yet recruiting
Hospital Universitario Basurto
Bilbao, Bizkaia, 48013
Iñigo Cearra, doctor, 34 944 00 60 00, uiceecc.regulatoria@bio-bizkaia.eus
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy and Safety of Platelet-Rich Plasma (PRP) Injection Combined With Physical Exercise in Chronic Omalgia
The experimental group will receive intralesional injections of platelet-rich plasma, evaluating its ability to relieve pain and provide sustained improvement through biological modulation of the joint and tendon environment. In contrast, the control group will be treated with a combination of betamethasone and ropivacaine, representing the current standard of care for short-term inflammatory pain management. The comparison between these two options will determine whether platelet-rich plasma offers advantages in terms of clinical efficacy and duration of benefits. The results obtained could contribute significantly to the development of more effective protocols and more precise management guidelines for patients with chronic omalgia, thus addressing existing controversies and improving clinical practice.
- Conditions
- Chronic Pain
- Being tested
- Platelet-rich Plasma Local injection, betamethasone and Ropivacaine
- Keywords
- omalgia
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich Plasma Local injectionBiological
Two procedures are considered for obtaining an equivalent PRP formulation, with the aim of establishing a contingency plan for possible situations such as a shortage of specific materials (extraction tubes) or the unavailability of a dedicated clean room for preparation under open circuit conditions. PRP produced in-house, following the open technique, is prepared in a laminar flow cabinet within an environment that complies with the standards of asepsis and Good Manufacturing Practices required for this type of preparation.
betamethasone and RopivacaineDrug
consists of a mixture of 2 cc of betamethasone and 2 cc of ropivacaine. To prepare it, 2 cc of betamethasone will be extracted from an ampoule of injectable solution using a sterile syringe (without attaching the needle) and mixed with 2 cc of ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| platelet-rich plasma | Experimental | Two procedures are considered for obtaining an equivalent PRP formulation, with the aim of establishing a contingency plan for possible situations such as a shortage of specific materials (extraction tubes) or the unavailability of a dedicated clean room for preparation under open circuit conditions. PRP produced in-house, following the open technique, is prepared in a laminar flow cabinet within an environment that complies with the standards of asepsis and Good Manufacturing Practices required for this type of preparation. Receives: Biological: Platelet-rich Plasma Local injection |
| betamethasone + ropivacaine | Active comparator | The control treatment consists of a mixture of 2 cc of betamethasone and 2 cc of ropivacaine. Receives: Drug: betamethasone and Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional improvement between the intervention group and the control group measured by the absolute change in the Constant-Murley scale score
Evaluate the efficacy of two PRP injections versus two injections of betamethasone with ropivacaine, both combined with a personalized exercise program, in the treatment of chronic shoulder pain secondary to rotator cuff tendinopathy.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start24 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobizkaia Health Research Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448285
- Sponsor's protocol ID
- SHIELD-PRP
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy and Safety of Platelet-Rich Plasma (PRP) Injection Combined With Physical Exercise in Chronic Omalgia
- ClinicalTrials.gov ID
- NCT07448285
- Acronym / sponsor ID
- SHIELD-PRP
- Conditions
- Chronic Pain
- Keywords
- omalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Biobizkaia Health Research InstituteOther government
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 4 Mar 2026 (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 experimental group will receive intralesional injections of platelet-rich plasma, evaluating its ability to relieve pain and provide sustained improvement through biological modulation of the joint and tendon environment. In contrast, the control group will be treated with a combination of betamethasone and ropivacaine, representing the current standard of care for short-term inflammatory pain management. The comparison between these two options will determine whether platelet-rich plasma offers advantages in terms of clinical efficacy and duration of benefits. The results obtained could contribute significantly to the development of more effective protocols and more precise management guidelines for patients with chronic omalgia, thus addressing existing controversies and improving clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet-rich plasma | Experimental | Biological: Platelet-rich Plasma Local injectionTwo procedures are considered for obtaining an equivalent PRP formulation, with the aim of establishing a contingency plan for possible situations such as a shortage of specific materials (extraction tubes) or the unavailability of a dedicated clean room for preparation under open circuit conditions. PRP produced in-house, following the open technique, is prepared in a laminar flow cabinet within an environment that complies with the standards of asepsis and Good Manufacturing Practices required for this type of preparation. |
| betamethasone + ropivacaine | Active comparator | Drug: betamethasone and RopivacaineThe control treatment consists of a mixture of 2 cc of betamethasone and 2 cc of ropivacaine. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between 35 and 75 years of age, both inclusive.
- Presence of pain in the affected shoulder for 3 or more months.
- Body Mass Index (BMI) values between 20 and 27 kg/m2, including both values.
- Confirmed diagnosis of chronic shoulder pain associated with rotator cuff tendinopathy, following an unfavorable response to standard treatment with analgesics and nonsteroidal anti-inflammatory drugs for 4-6 weeks.
- Patients who agree to participate in the study and sign the informed consent form.
Key exclusion criteria (14 listed)
- Confirmed diagnosis of complete rotator cuff tear.
- Patients with systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
- Patients with diabetes mellitus.
- Patients with hematological disorders (thrombopathy, thrombocytopenia, anemia with Hb<9 g/dl).
- Patients undergoing immunosuppressive treatment at the time of inclusion.
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 |
|---|---|---|
| Platelet-rich Plasma Local injectionTwo procedures are considered for obtaining an equivalent PRP formulation, with the aim of establishing a contingency plan for possible situations such as a shortage of specific materials (extraction tubes) or the unavailability of a dedicated clean room for preparation under open circuit conditions. PRP produced in-house, following the open technique, is prepared in a laminar flow cabinet within an environment that complies with the standards of asepsis and Good Manufacturing Practices required for this type of preparation. | Biological | platelet-rich plasma |
| betamethasone and Ropivacaineconsists of a mixture of 2 cc of betamethasone and 2 cc of ropivacaine. To prepare it, 2 cc of betamethasone will be extracted from an ampoule of injectable solution using a sterile syringe (without attaching the needle) and mixed with 2 cc of ropivacaine. | Drug | betamethasone + ropivacaine |
Primary outcome
functional improvement between the intervention group and the control group measured by the absolute change in the Constant-Murley scale score
Time frame: 36 months
Evaluate the efficacy of two PRP injections versus two injections of betamethasone with ropivacaine, both combined with a personalized exercise program, in the treatment of chronic shoulder pain secondary to rotator cuff tendinopathy.
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 4 Mar 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet-rich Plasma Local injection and betamethasone and Ropivacaine in people with Chronic Pain, run by Biobizkaia Health Research Institute at 2 sites 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 5 inclusion and 14 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional improvement between the intervention group and the control group measured by the absolute change in the Constant-Murley scale score (time frame: 36 months). 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 4 Mar 2026.