Randomised Clinical Study to Assess the Efficacy and Safety of Platelet-Rich Plasma (Prp) Infiltration Combined with Physical Exercise in Chronic Omalgia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

13 Jan 2026 → ongoing

Decision date (initial)

2025-10-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of two PRP injections compared to two betamethasone + ropivacaine injections, both supplemented with a personalised exercise programme, for the treatment of chronic omalgia secondary to rotator cuff tendinopathy.

Secondary objectives 6

1. To compare the clinical response, in terms of pain and function, between patients treated with PRP and those treated with betamethasone and ropivacaine, both groups complemented with personalised physical exercise, throughout the follow-up of the study.
2. To evaluate the evolution of the ultrasound characteristics associated with omalgia at the 6 and 12-month follow-up visits with respect to baseline, comparing patients treated with PRP and those treated with betamethasone and ropivacaine, both groups supplemented with personalised physical exercise.
3. To assess changes in muscle balance, joint movement and pain at 6 and 12 months, comparing patients treated with PRP versus those treated with corticosteroids, both groups supplemented with personalised physical exercise.
4. To compare joint mobility at 12 months follow-up between patients treated with PRP and those treated with corticosteroids, both groups supplemented with personalised physical exercise.
5. To determine the progression in the level of complexity of the physical exercises performed by the patients over the 12 months of intervention, assessing the differences between the PRP and corticosteroid treatment groups.
6. To assess the safety of PRP versus corticosteroid infiltrations in the treatment of chronic omalgia by comparing the frequency, intensity and severity of adverse reactions throughout the study.

Conditions and MedDRA coding

CHRONIC OMALGIA

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients aged between 35 and 75 years, both included.
2. Presence of pain in the affected shoulder with an intensity ≥3 points out of 10 on the visual analogue scale (VAS), assessed during the screening visit.
3. Body Mass Index (BMI) values between 20 and 27kg/m2, both values included.
4. Confirmed diagnosis of chronic omalgia associated with rotator cuff tendinopathy, following an unfavourable response to the standard regimen of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) for 4-6 weeks.
5. Patients who agree to participate in the study and sign the informed consent form.

Exclusion criteria 14

1. Confirmed diagnosis of complete rotator cuff tendon rupture.
2. Patients with systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotising vasculitis).
3. Poorly controlled diabetes mellitus, defined as glycosylated haemoglobin >9%.
4. Patients with haematological disorders (thrombopathy, thrombopenia, anaemias with Hb<9 g/dl).
5. Patients undergoing immunosuppressive treatment.
6. Patients under treatment with intramuscular corticosteroids in the 3 months prior to the first administration of the trial treatment.
7. Patients on treatment with non-steroidal anti-inflammatory drugs (more than 10 consecutive days at usual doses), opioids or oral corticosteroids during the 15 days prior to study treatment.
8. Patients with severe heart disease.
9. Patients with active cancer or cancer diagnosed within the last 5 years.
10. Patients who are taking an investigational medicinal product or have participated in an investigational trial (with a licensed or unlicensed product) in the 30 days prior to randomisation.
11. Patient with any physical, social, or psychological impairment that, in the opinion of the investigators, may affect the patient's participation in the trial or the validity of the data obtained from the patient's participation in the trial.
12. Pregnant women.
13. Breastfeeding women.
14. Women of childbearing age* who are unable or unwilling to use contraceptive methods with a failure rate <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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The difference in functional improvement between the intervention group (PRP infiltration combined with physical exercise) and the control group (corticosteroid infiltration combined with physical exercise), measured by the absolute change in the Constant-Murley scale (CMS) score at 6 months post-treatment, compared to the baseline score (14). An increase ≥ 10 points in the CMS score (15), in the absence of serious treatment-related complications, is considered a therapeutic success.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Sponsor organisation

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Address

Cruces Plaza 12

City

Barakaldo

Postcode

48903

Country

Spain

Scientific contact point

Organisation

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Contact name

UIC REGULATORIA

Public contact point

Organisation

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Contact name

UIC REGULATORIA

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications