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Université d'Istanbul - CerrahpaşaVagus Nerve Stimulation Effect in Frozen Shoulder Treatment 40 Exercice
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07368751 est une étude interventionnel pour Épaule gelée. Son statut actuel est : en recrutement. L'étude a débuté le 2 février 2026 et vise à recruter 40 participants. Dirigée par l'Université d'Istanbul - Cerrahpaşa, l'étude devrait être terminée d'ici le 1 mars 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 4 février 2026.
Résumé succinct
The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder.
The main questions this study aims to answer are:
Does adding tVNS to exercise reduce shoulder pain ? Does adding tVNS to exercise improve shoulder function and s...
Afficher plusDescription détaillée
This is a randomized, double-blind (participants and outcome assessors), sham-controlled study. Participants will be recruited from a university hospital. Volunteers diagnosed with frozen shoulder who meet the inclusion criteria and are referred by an orthopedics and traumatology specialist will be included.
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Partici...
Afficher plusTitre officiel
Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial
Pathologies
Épaule geléeAutres identifiants de l'étude
- IUC-FTR-SA-01
Numéro NCT
Date de début (réel)
2026-02-02
Dernière mise à jour publiée
2026-02-04
Date de fin (estimée)
2027-03-01
Inscription (estimée)
40
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Frozen Shoulder
Vagus Nerve Stimulation
Exercise
Vagus Nerve Stimulation
Exercise
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Expérimentaltranscutaneous Vagus Nerve Stimulation (tVNS) plus exercises the interventional group will receive active tVNS plus exercise therapy including traditional exercises and home exercises. | Active tVNS plus exercises This program will be performed 3 times per week for 6 weeks. Each session will include 30 minutes of tVNS. Stimulation will be delivered to the auricular branch of the vagus nerve using a non-invasive transcutaneous device. Electrodes will be placed on the tragus and concha regions of the ear. in addition to traditional exercises including mobilization, ROM exercises, stretching and strengthening exercises. |
Comparateur facticeSham controlled tVNS plus exercises the control group will receive Sham-controlled tVNS plus exercise therapy including traditional exercises and home exercises. | Sham controlled tVNS plus exercises This program will be performed three times per week for six weeks. In each session, 30 minutes of sham tVNS will be applied, during which the device will remain inactive, in addition to traditional exercise therapy including joint mobilization, range of motion exercises, stretching, and strengthening exercises. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change from baseline in the Shoulder Pain and Disability Index (SPADI) at weeks 6 and 12. | The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability levels in patients. SPADI consists of 13 items and includes two subscales: pain and disability. The pain subscale consists of 5 items while the disability subscale consists of 8 items. Both subscale scores and the total score are calculated on a 0-100 scale, with higher scores indicating greater pain and disability. | Change from baseline in SPADI score at weeks 6 and 12 |
Change from baseline of Numerical Rating Pain Scale (NPRS) at week 6 and week 12 | Pain intensity will be assessed using the Numerical Rating Pain Scale (NPRS). Participants will be asked to rate the intensity of their shoulder pain on a scale from 0 to 10, with higher scores indicating greater pain. | Change from baseline in NPRS score at week 6 and week 12 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change from baseline in Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) score at week 6 and week 12 | QuickDASH is a patient-reported outcome measure and will be used to assess upper extremity function and symptoms. The total score ranges from 0 to 100, with higher scores indicating greater functional disability. | Change from baseline in QuickDASH score at weeks 6 and 12 |
Change from baseline in Pain Catastrophizing Scale (PCS) score at week 6 and week 12 | The Pain Catastrophizing Scale (PCS) will be used to assess rumination, magnification, and helplessness related to pain. The scale yields a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. | Change from baseline in PCS score at weeks 6 and 12 |
change from baseline in the Glenohumeral Joint Range of Motion at week 6 and week 12 | Glenohumeral joint range of motion will be assessed using a universal goniometer, a widely used and reliable method for measuring shoulder joint mobility. | Change from baseline in range of motion at weeks 6 and 12 |
Change from baseline in Pain Self-Efficacy Questionnaire (PSEQ) score at week 6 and week 12 | The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report questionnaire designed to assess an individual's confidence in performing activities despite pain. Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy. | Change from baseline in PSEQ score at weeks 6 and 12 |
Treatment satisfaction assessed with the Global Rating of Change (GRC) Scale at weeks 6 and 12 | GRC scale is designed to measure a patient's perceived improvement or deterioration over time to determine the effect of an intervention. A 5-point scale ranging from -2 to +2 will be used (-2 = much worse, -1 = worse, 0 = no change, +1 = better, +2 = much better). | At weeks 6 and 12 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
40 Years
Sexes éligibles
Tous
- Age between 40 and 65 years.
- Less than 50% range of motion compared with the contralateral shoulder in at least one movement (external rotation, abduction, flexion, or internal rotation).
- More than 25% loss of range of motion in at least two movement planes compared with the unaffected shoulder.
- Increasing limitation of glenohumeral external and internal rotation during abduction from 45° to 90°.
- Shoulder pain lasting at least 3 months during activities of daily living.
- Passive joint range of motion within normal limits
- External rotation range of motion <30°
- Radiographic evidence of glenohumeral arthritis
- Presence of inflammatory joint disease
- Previous treatment related to the current shoulder complaint (physiotherapy and rehabilitation, intra-articular injection, or surgery)
- Pain intensity <3 according to the Numerical Pain Rating Scale (NPRS)
- Presence of neurological deficits, cardiac disease, neuropathic disorders, or pregnancy
Université d'Istanbul - Cerrahpaşa174 essais cliniques actifs à explorerPartie responsable de l'étude
Salam Alruz, Investigateur principal, Principal Investigator, Istanbul University - Cerrahpasa
Contact central de l'étude
Contact: Salam Alruz, MSc, +90 5510805265, [email protected]
1 Centres de l'étude dans 1 pays
Istanbul University-Cerrahpaşa, Istanbul, Turkey (Türkiye)
Salam Alruz, Msc, Contact, +90 5510805265, [email protected]
Derya Çelik, Investigateur associé
En recrutement