EFFICACY OF SUPRASPINATUS NERVE APPROACH THROUGH CORTICOSTEROID ADMINISTRATION VERSUS PULSED RADIOFREQUENCY IN CHRONIC SHOULDER PAIN. DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL.

Start 15 Jan 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 76

Countries 1

Sites 1

Chronic shoulder pain

Evaluation of Improvement in Shoulder Functionality and Pain Measured by the SPADI Test in Patients with Chronic Shoulder Pain: Comparison of Suprascapular Nerve Block with Corticosteroids versus Pulsed Radiofrequency.

Key facts

Sponsor: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration: 15 Jan 2025 → ongoing
Decision date (initial): 2025-01-15
Transition trial: Yes
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-519892-24-00
EudraCT number: 2017-004612-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

Secondary objectives 7

Pain assessment using the Visual Analog Scale (VAS) and Numerical Verbal Scale (NVS).
Assessment of both active and passive mobility; range of motion of the shoulder, including elevation, abduction, and external rotation.
Assessment of the reduction in the need for analgesics.
Assessment of anxiety and quality of life (HAD scale, EuroQoL).
Assessment of sleep quality (MOS scale).
Assessment of patient satisfaction with the treatment received.
Comparison of safety between both techniques.

Conditions and MedDRA coding

Chronic shoulder pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Men and women scheduled for suprascapular nerve block due to shoulder pain (omalgia).
Age >18 years.
Shoulder pain (omalgia) lasting >3 months.
Signed informed consent form.

Exclusion criteria 11

Allergy to corticosteroids.
Patient refusal.
Blood dyscrasias.
Inability to perform the infiltration due to technical difficulties.
Lack of understanding of the informed consent document.
Pregnancy or breastfeeding.
External causes of shoulder pain (omalgia), such as secondary to stroke, post-surgical conditions (shoulder surgery, laparoscopic surgery, or thoracic surgery), or cervicobrachial syndrome.
Severe pain in other locations, specifically in cases of polymyalgic syndromes (fibromyalgia), other conditions with poor response to treatments (chronic fatigue syndrome), or at the physician's discretion.
Participation in other studies that may affect the results.
Systemic infections.
Women of childbearing potential not using highly effective contraceptive methods (as defined in the ICH M3 guidance, Note 3).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The SPADI (Shoulder Pain and Disability Index) is a quality-of-life questionnaire designed to evaluate pain and disability related to shoulder pathology.

Secondary endpoints 10

Demographics
Comorbidity
Visual Analog Scale (VAS)
Numerical Verbal Scale (NVS)
Range of Motion
Amount of Analgesics Administered
Hospital Anxiety and Depression Scale (HAD)
EuroQol 5D (EQ-5D)
Medical Outcomes Study Sleep Scale (MOS)
Satisfaction Assessment

Investigational products

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

Test 1

TRIGON DEPOT 40 mg/ml suspensión inyectable.

PRD348023 · Product

Active substance: Triamcinolone Acetonide
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: PERINEURAL USE
Max daily dose: 80 mg milligram(s)
Max total dose: 80 mg milligram(s)
Max treatment duration: 1 Month(s)
Authorisation status: Authorised
ATC code: H02AB08 — TRIAMCINOLONE
Marketing authorisation: 44.901
MA holder: BRISTOL-MYERS SQUIBB SA
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Sponsor organisation: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Address: Calle Sant Quinti 77-79
City: Barcelona
Postcode: 08041
Country: Spain

Scientific contact point

Organisation: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Contact name: Alejandra Espinosa

Public contact point

Organisation: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Contact name: Alejandra Espinosa

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Ongoing, recruiting	76	1
Rest of world	—	0	—

Investigational sites

Spain

1 site · Ongoing, recruiting

Hospital De La Santa Creu I Sant Pau

Anesthesiology, Resuscitation and Pain Therapy, Calle De San Antonio Maria Claret 167, 08025, Barcelona

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Spain	2025-01-15		2025-01-15

Results and documents

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

Documents 4 files

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

Type	Title	Version
Protocol (for publication)	D1_Protocol 2024-519892-24-00 fp	3
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_SIS and ICF fp	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Trigon_depot	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-12-23	Spain	Acceptable 2025-01-15	2025-01-15

Efficacy of Supraspinatus Nerve Approach Through Corticosteroid Administration Versus Pulsed Radiofrequency in Chronic Shoulder Pain. Double-Blind Randomized Clinical Trial.