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Lo studio clinico NCT07134010 (PIT; AC) per Capsulite adesiva 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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The Impact of Perineural Injection Therapy for Adhesive Capsulitis. (PIT; AC) 24 Domiciliare Esercizio

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07134010 (PIT; AC) è uno studio interventistico per Capsulite adesiva, attualmente in arruolamento. Avviato il 3 giugno 2025, prevede di arruolare 24 partecipanti. Sotto la guida di Universiti Teknologi Mara, dovrebbe concludersi entro il 1 giugno 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 4 settembre 2025.
Sommario breve
The goal of this clinical trial is to learn if Perineural Injection Therapy (PIT) works to treat adhesive capsulitis (frozen shoulder) in adults. It will also learn about the safety of PIT.

The main questions it aims to answer are:

Does PIT reduce shoulder pain and improve shoulder range of motion more effectively than conventional therapy alone?

What side effects or medical problems do participants experience whe...

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Descrizione dettagliata
Study Title:

The Impacts of Perineural Injection Therapy on Adhesive Capsulitis in a Single Centre Hospital in Selangor: A Randomized Controlled Trial Pilot Study

Study Overview :

Adhesive capsulitis, commonly known as "frozen shoulder," is a painful condition that limits shoulder movement and affects daily activities such as dressing, reaching overhead, or lifting objects. It often affects adults between the ages...

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Titolo ufficiale

The Impact of Perineural Injection Therapy for Adhesive Capsulitis at a Single Centre University Hospital in Selangor: A Pilot Study

Patologie
Capsulite adesiva
Altri ID dello studio
  • PIT; AC
  • REC/06/2025 (PG/FB/26)
Numero NCT
NCT07134010
Data di inizio (effettiva)
2025-06-03
Ultimo aggiornamento pubblicato
2025-09-04
Data di completamento (stimata)
2026-06-01
Arruolamento (previsto)
24
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Perineural injection therapy in treating Adhesive Capsulitis
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleIntervention group
Perineural injection Therapy
perineural injection
Intervention The procedure will be performed by a rehabilitation physician who has obtained hospital-level credentialing and privileging to practice Perineural Injection Therapy (PIT). The physician has undergone hands-on training with Dr. Lyftogt-certified trainers in Malaysia. PIT will be administered weekly for six week (Total 6 sessions). In addition to this intervention, patient will also receive conventional t...Mostra di più
Fisioterapia
Patients will be receiving a structured home-based exercise program and will be instructed on how to perform these exercises at home. The exercise regime will be 30 minutes, 3 times a day to enhance shoulder mobility and strength in addition to the regular monthly outpatient physiotherapy session. Oral analgesics exclude NSAIDs will be prescribed as needed to manage pain.
Comparatore simulatoConventional group
Physiotherapy
Fisioterapia
Patients will be receiving a structured home-based exercise program and will be instructed on how to perform these exercises at home. The exercise regime will be 30 minutes, 3 times a day to enhance shoulder mobility and strength in addition to the regular monthly outpatient physiotherapy session. Oral analgesics exclude NSAIDs will be prescribed as needed to manage pain.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Numerical Rating Scale
Participants will rate their shoulder pain on a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain."
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Shoulder Range of Motion (ROM)
Tool: Goniometer (standardized physical measurement) Passive ROM will be measured in four directions: forward flexion, abduction, internal rotation, and external rotation. Values will be recorded in degrees.
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Functional Outcome
Tool: Shoulder Pain and Disability Index (SPADI) - validated English and Malay versions A self-reported questionnaire with 13 items divided into two subscales: 5 for pain and 8 for functional disability. Each item is scored from 0 (no pain/disability) to 10 (worst pain/disability), with higher scores indicating greater impairment.
Measured at baseline (Week 0), post-treatment (Week 6), 1-month follow-up (Week 10), and 3-month follow-up (Week 18).
Adverse Reactions
Tool: Adverse Event Reporting Form and Patient Diary Description: Side effects will be classified into: Mild: Local pain, bruising, or redness Moderate: Transient numbness, swelling, or prolonged discomfort Severe: Infection or allergic reaction
Monitored throughout the 6-week intervention
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  1. Age 18 and above.
  2. Diagnosed with primary adhesive capsulitis by a specialist.
  3. Limitation of range of motion ≥ 50% relative to the normal side or normal reference (in patient with bilateral adhesive capsulitis) in three or more movement directions (i.e., external rotation, abduction, forward flexion, and internal rotation).
  4. Chronic adhesive capsulitis shoulder pain lasting for at least 3 months.
  5. Pain score of at least 4/10 on the Numerical Rating Scale (NRS) during movement, indicating at least moderate pain severity.
  6. Consented to the study.

  1. Received any shoulder pain injection within the past 6 weeks or surgical intervention such manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
  2. Diagnosed with other shoulder pathology such as neurologic deficits affecting shoulder function, tumour, rotator cuff injury or fracture.
  3. Has history of allergy to dextrose solution.
  4. Patients receiving steroidsimmunosuppressants, psychotropic medication, or other medications that may affect, the clinical outcomes
  5. Patients with haemorrhagic disease, taking anticoagulant drugs, or patients with severe diabetes mellitus having an increased risk of infection (HBA1c >8%)
  6. Do not understand Malay or English language.
  7. Unable to follow a 3 steps command.
Universiti Teknologi Mara logoUniversiti Teknologi Mara
Parte responsabile dello studio
Noor Hafizah Binti Samsudin Bahari, Investigatore principale, Medical Doctor, Universiti Teknologi Mara
Contatti principali dello studio
Contatto: Noor Hafizah Samsudin Bahari, MD(UKM), +60333963395, [email protected]
Contatto: Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehabMed(UM), +60333963395, [email protected]
1 Centri dello studio in 1 paesi

Selangor

Hospital Al-Sultan Abdullah, UiTM Puncak Alam, Kuala Selangor, Selangor, 42300, Malaysia
Noor Hafizah Samsudin Bahari, MD(UKM), Contatto, +60333963395, [email protected]
Dr Anie Farhana Ngimron, MBBChBAO(Ireland)MRehab(UM), Contatto, +60333963395, [email protected]
Assoc. Prof. Dr. Nadia Mohd Mustafah, MD(UPM)MRehab(UM), Sub-investigatore
In arruolamento