Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis (EBLOUIR)

25. juni 2026 opdateret af: Nantes University Hospital

Drug Trial

  • Single-center
  • Exploratory trial
  • Controlled
  • Randomized
  • Double-blind
  • Prospective

Objective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection combined with a placebo block 19 patients in the Experimental Group (block with corticosteroid and intra-articular injection on Day 0) 19 patients in the Control Group (block with saline and intra-articular injection on Day 0)

  • Total duration: 36 months
  • Recruitment period: 24 months
  • Treatment duration per patient: 2 ultrasound-guided procedures on Day 0
  • Follow-up duration per patient: 12 months after the procedure

At J0 : Under ultrasound guidance, inject 2 mL of lidocaine into the notch, then:

  • Experimental Group: 8 mL of 1% lidocaine into the notch with 1 mL of betamethasone,
  • Control Group: 9 mL of saline into the notch.

During these consultations, M1, M3, M6 et M12 , the following examinations will be performed:

  • Clinical examination of the painful shoulder, including measurement of range of motion
  • Visual Analog Scale (VAS) for pain
  • Quick Dash, OSS, and SPADI self-report questionnaires completed by the patient
  • Recording of complications
  • Questions about returning to work

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

38

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients with shoulder pain and stiffness that has persisted for at least 2 months but less than 12 months, with a loss of passive range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, forward flexion) of at least 30 degrees compared to the contralateral side
  • Patients between the ages of 18 and 65
  • Patients enrolled in a social security program

Exclusion Criteria:

  • - Corticosteroid injection into the affected shoulder < 4 months ago
  • History of any surgery on the affected shoulder within the past 12 months
  • Patients with a neuromuscular condition (neurological deficit) or shoulder condition (arthropathy) that could interfere with the assessment of the primary endpoint
  • Signs or risk of infection (bacterial-like infection and/or fever and/or antibiotic use)
  • Poor skin condition of the affected shoulder
  • Anticoagulation with VKAs or anti-Xa agents, or active bleeding disorder or one in remission for less than 5 years (malignant hematologic disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents permitted except prasugrel and clopidogrel)*
  • Uncontrolled hypertension,
  • Decompensated diabetes or diabetes at risk of decompensation,
  • Contraindications to diprosten, Kenacort, or lidocaine
  • Psychiatric conditions that may be exacerbated by corticosteroids
  • Pregnant or breastfeeding women, or women who refuse to use effective contraception
  • Individuals belonging to a vulnerable group as defined by Regulation (EU) No. 536/2014 and French law (See section 4.4 of the protocol) - - Patients unable to comply with the protocol requirements (see Section 4.4 of the protocol)
  • Patients participating in another clinical research protocol involving a drug or medical device
  • Patients who refuse to participate in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diprostene

Supracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®.

Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
Medicin: Diprostene

Supracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®.

Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
Placebo komparator: Saline Solution

Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline.

Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
Medicin: Saline (0.9% NaCl)

Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline.

Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Difference in Quick DASH scores between baseline and M3
Tidsramme: 3 months
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1. Functional Assessment
Tidsramme: D0, Month 1, Month 3, Month 6, month 12
Function using the Quick Dash
D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment
Tidsramme: D0, Month 1, Month 3, Month 6, month 12
Function using the SPADI scores
D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment
Tidsramme: D0, Month 1, Month 3, Month 6, month 12
Function using the OSS
D0, Month 1, Month 3, Month 6, month 12
Measuring Joint Ranges of Motion with a Goniometer
Tidsramme: Day 0, Month 1, Month 3, Month 6, and Month 12
Day 0, Month 1, Month 3, Month 6, and Month 12
Pain Assessment
Tidsramme: D0, Month 1, Month 3, Month 6, month 12
With VAS (Visual Analog Scale) 0-10
D0, Month 1, Month 3, Month 6, month 12
EVA pain before and after each movement
Tidsramme: Day 0, Month 1, Month 3, Month 6, and Month 12
Day 0, Month 1, Month 3, Month 6, and Month 12
Return-to-work timelines following the procedure for patients who are employed
Tidsramme: Month 1, Month 3, Month 6, and Month 12
Month 1, Month 3, Month 6, and Month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. juni 2026

Primær færdiggørelse (Anslået)

25. juni 2029

Studieafslutning (Anslået)

25. juni 2029

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC25_0554
  • 2026-525317-31-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Retractile Capsulitis

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malta

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner