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Lo studio clinico NCT06553716 per Postoperation Pain è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis 70
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La sperimentazione clinica NCT06553716 è uno studio interventistico per Postoperation Pain, attualmente in arruolamento. Avviato il 5 febbraio 2024, prevede di arruolare 70 partecipanti. Sotto la guida di General Hospital of Ningxia Medical University, dovrebbe concludersi entro il 30 novembre 2024. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 settembre 2024.
Sommario breve
The purpose of this study was to compare the efficacy of ultrasus-guided hydrodilation of Rotator Cuff Interval combined with Posterior Glenohumeral recess approach and hydrodilation of the Rotator cuff Interval alone in Adhesive Capsulitis.
Descrizione dettagliata
For patients with perihumeral arthritis, shoulder capsule hydrodilation is usually performed using ultrasound-guided water dilation through the posterior glenohumeral recess. Recently, a new transrotator cuff space approach has been described, and this study was designed to compare the efficacy of triamcinolone olonide transrotator cuff space combined with posterior glenohumeral recess and rotator cuff space dilation...Mostra di più
Titolo ufficiale
Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis:The Effect of the Rotator Cuff Interval With Posterior Glenohumeral Recess Approaches on the Improvement of Joint Motion and Pain
Patologie
Postoperation PainAltri ID dello studio
- Peng Ma-2024-0201
Numero NCT
Data di inizio (effettiva)
2024-02-05
Ultimo aggiornamento pubblicato
2024-09-20
Data di completamento (stimata)
2024-11-30
Arruolamento (previsto)
70
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Adhesive capsulitis
hydrodilatation
corticosteroid
rotator cuff interval
Posterior Glenohumeral Recess
hydrodilatation
corticosteroid
rotator cuff interval
Posterior Glenohumeral Recess
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoRotator cuff space approach (GroupA) In the Rotator cuff interval recess group,we injected 20 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into into the Rotator cuff interval/anterior capsule. | Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recess The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval recess group,we injected 20 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into into the Rotator cuff interval/anterior capsule. |
SperimentaleRotator cuff space approach combined with posterior glenohumeral recess approach (GroupB) In the Rotator cuff interval and posterior glenohumeral recess group,we injected 10 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the Rotator cuff interval/anterior capsule and 10 mL mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the posterior glenohumeral. | Ultrasound-Guided Hydrodilatation by the Rotator cuff interval and posterior glenohumeral recess The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval and posterior glenohumeral recess group,we injected 10 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the Rotator cuff interval/anterior capsule and 10 mL mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Shoulder Pain and Disability Index | The SPADI was used to assess the severity ofpain and disability. A previous study has shown that the Chinese version of the SPADI has high internal consistency and test-retest reliability (Yao et al., 2017). It consists of 13 items that are divided into 2 subscales: pain scale (5 items) and disability scale (8 items) (Roach et al., 1991). Each item is rated from 0 (no pain/no difficulty) to 10 (worst pain experienced/ very difficult). The score is then transformed to a 100-point scale, with the highest score indicating the most severe pain and disability. In the literature, the minimal and clinically relevant difference for SPADI has been reported to be 10 points | At baseline, one week, three weeks, six weeks, 12 weeks after treatment. |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
visual analogue scale | Regarding VAS, patients were asked to indicate the intensity of their average level ofpain in the affected shoulder within the past 1 week using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable). | At baseline, one week, three weeks, six weeks, 12 weeks after treatment. |
Active shoulder range of motion | In terms of ROM, the degrees of shoulder flexion, abduction, external and internal rotation were measured by a goniometer in the supine position in a random sequence | Baseline data, six weeks,12 weeks after treatment |
adverse reaction | Pain after hydrodilation , reduced sensation and motor control of the affected arm, skin flushing, nausea, dizziness, and fainting | one week after treatment |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
- Age ≥18 years old, clinical diagnosis of periarthritis of shoulder;
- symptom duration > 1 month, shoulder ROM limitation in at least two directions, defined as abduction < 80°, flexion < 130°, and rotation < 30°;
- Before enrollment, the patients received plain radiographs, ultrasound images, and magnetic resonance imaging to rule out the cause of secondary shoulder capsitis.
- Secondary frozen shoulder, such as rotator cuff tear, calcifying tendinitis, osteoarthritis, infection, tuberculosis infection, rheumatic disease, shoulder impingement syndrome;
- Previous history of shoulder joint surgery;
- Involved cervical nervous system symptoms or abnormal nervous system;
- corticosteroid injection in the affected shoulder within 3 months;
- Mental illness;
- Patients with contraindications to cortisol-hormone use.
General Hospital of Ningxia Medical UniversityContatti principali dello studio
Contatto: Xinli Ni, MD, 13909586966, [email protected]
Contatto: Peng Ma, 18209631464, [email protected]
1 Centri dello studio in 1 paesi
Ningxia
General hospital of Ningxia medical university, Yinchuan, Ningxia, 750004, China
Xinli Ni, MD, Contatto, 13909586966, [email protected]
Peng Ma, Contatto, 18209631464, [email protected]
In arruolamento