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Lo studio clinico NCT07163884 per Capsulite adesiva, Ecografia, Fascia, Treatment (ProudMe) è non ancora 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 Effect of Fascial Treatment in Patients With Adhesive Capsulitis 36
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La sperimentazione clinica NCT07163884 è uno studio interventistico per Capsulite adesiva, Ecografia, Fascia, Treatment (ProudMe), attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 15 settembre 2025, con l'obiettivo di raggiungere 36 partecipanti. Sotto la guida di Hasan Kalyoncu University, dovrebbe concludersi entro il 15 novembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 9 settembre 2025.
Sommario breve
Our study is unique in that it utilizes a self-designed fascial mobilization protocol and ultrasonographic evaluation for adhesive capsulitis. Therefore, the aim of our study is to investigate the effects of fascial therapy on pain, normal joint range of motion, proprioception, and fascial architecture in patients diagnosed with adhesive capsulitis.
Descrizione dettagliata
Adhesive capsulitis (AC) is a common shoulder condition characterized by a gradual increase in spontaneous pain and a limitation in glenohumeral joint range of motion. Its pathophysiology, a pathological process of capsular fibrosis following synovial inflammation, is relatively well understood, but its cause remains unknown. The literature on the treatment of frozen shoulder, whose etiology remains unknown, provides...Mostra di più
Titolo ufficiale
Adheziv kapsülit tanılı Hastalarda Fasyal Tedavinin ağrı, Normal Eklem Hareket açıklığı, Propriosepsiyon ve Fasya Mimarisine Etkisinin araştırılması
Patologie
Capsulite adesivaEcografiaFasciaTreatment (ProudMe)Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- 2025/111
Numero NCT
Data di inizio (effettiva)
2025-09-15
Ultimo aggiornamento pubblicato
2025-09-09
Data di completamento (stimata)
2025-11-15
Arruolamento (previsto)
36
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
adhezsiv capsulitis
pain
range of motion
proprioception
fascia architecture
pain
range of motion
proprioception
fascia architecture
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleFascial therapy group In addition to electrotherapy, the patients in the study group will receive a total of five sessions (one day per week for five weeks) of fascial therapy. The protocol will be developed by us. Fascial mobilization will be performed by a trained physiotherapist on the pectoral fascia, deltoid fascia, axillary fascia, and supscapularis fascia, once a week, for 180 seconds each repetition. These sessions will be perform...Mostra di più | Facsial therapy In addition to electrotherapy, the patients in the study group will receive a total of five sessions (one day per week for five weeks) of fascial therapy. The protocol will be developed by us. Fascial mobilization will be performed by a trained physiotherapist on the pectoral fascia, deltoid fascia, axillary fascia, and supscapularis fascia, once a week, for 180 seconds each repetition. These sessions will be perform...Mostra di più |
Comparatore attivoControl group Patients will receive 15 sessions of electrotherapy. A 15-minute hotpack will be applied, followed by a 20-minute TENS application, and then a 6-minute deep heating (1.5 Hz ultrasound) will be applied. Pre-treatment assessments will be repeated after treatment. | electrotherapy treatment Patients in the electrotherapy group will receive 15 sessions of TENS, hotpack, and ultrasound, 45 minutes each, 5 days a week, for 3 weeks. The treatment program is planned for 20 minutes of TENS, 15 minutes of hotpack, and 10 minutes of ultrasound. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Ultrasonographic Measurement | An ultrasound (measured by 7.5-10 MHz mobile ultrasound (ALEXUS A10HRL) device will be used to evaluate fascial architecture. The thickness and density of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of the biceps, and deltoid fascia, which constitute the patients' shoulder and fascial architecture and are among the structures most affected by adhesive capsulitis, will be evaluated. | through of the study, average 3 weeks |
The pain | Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. | through of the study, average 3 weeks |
Range of Motion | A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees. | through of the study, average 3 weeks |
Proprioception | Individuals shoulder proprioception will be measured with a laser pointer. A laser pointer is attached to the patient's arm, and the shoulder is flexed 90 degrees, and the laser reflection is marked on the wall. The patient is then asked to close their eyes and maintain the same degree of flexion. The laser reflection is marked. The distance between the two distances is recorded in centimeters. A greater deviation between the two distances indicates a greater loss of proprioception. | through of the study, average 3 weeks |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Upper extremity functionality | The Questionnaire for Arm, Shoulder, and Hand Disabilities (Q-DASH) will be used to assess individuals' upper extremity functions. This questionnaire is a self-administered measurement tool with validated validity and reliability in Turkish. The validity and reliability of the Turkish version of the DASH questionnaire (DASH-T) was conducted in Turkey by Düger et al. in 2006. The questionnaire, consisting of 30 questions, assesses the individual's ability to perform functional activities (21 items), pain (5 items), and psychosocial aspects of the disease (4 items). The total score ranges from 0 to 100, with a higher score indicating better outcomes. | through of the study, average 3 weeks |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
35 Years
Sessi idonei
Tutti
- Patients diagnosed with adhesive capsulitis by a specialist,
- Patients between the ages of 35 and 60,
- Those not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
- Those who have not participated in an upper extremity-related physiotherapy program within the last 6 months,
- Individuals who volunteer to participate in the study,
- Individuals who have undergone shoulder surgery consistent with any pathology,
- Individuals with a neurological history,
- Individuals diagnosed with diabetes mellitus (DM)
Hasan Kalyoncu UniversityParte responsabile dello studio
Tuğba GÖNEN, Investigatore principale, Asisst. Prof. Dr., Hasan Kalyoncu University
Contatti principali dello studio
Contatto: Tuğba GÖNEN, Asisst. Prof. Dr., 505 090 58 46, [email protected]
1 Centri dello studio in 1 paesi
Gaziantep
Hasan Kalyoncu University, Gaziantep, Gaziantep, (505) 090-5846, Turkey (Türkiye)