Routine Rehabilitation Versus Shock Wave Therapy for Scapular Dyskinesis
6 juin 2026 mis à jour par: Aliaa Mamdouh Abdelaziz Farag, Tanta University
Routine Rehabilitation Versus Shock Wave Therapy for Patients With Scapular Dyskinesis
It has been proposed that altered scapular muscle function can contribute to alterations in shoulder kinematics, which often lead to SD and are frequently associated with other shoulder pathologies, such as RC tears, labrum tears, impingement syndrome, and glenohumeral joint instability.
However, whether SD leads to the development of these diseases or is a consequence has yet to be clarified.
Changes in scapular kinematics can be attributed not only to altered scapular recruitment patterns (e.g., altered serratus anterior muscle activity) or muscle performance (e.g., force imbalance in the upper and lower trapezius muscles) but also to flexibility deficits in the soft tissue surrounding the scapula, which may restrict normal scapular movement during daily activities and sport- specific movements.
Although many studies have investigated the optimal management method, to date, there is no consensus.
Conservative approaches involve not only physiotherapy but also other techniques, such as extracorporeal shockwave therapy.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
This is a prospective, double-blinded, placebo-controlled randomised study.
The closed envelop randomization method will be used for the randomization of the patients who will be also blinded to group allocation.
The patients will be allocated into two groups:Group I: will be exposed to rESWT once weekly for one month Group II: will be exposed to ShamrESWT once weekly for one month.
During the study period, stretching exercises will be similarly given for both groups.
Type d'étude
Interventionnel
Inscription (Estimé)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Aliaa Mamdouh Abdelaziz Farag, MD
- Numéro de téléphone: 01069468486
- E-mail: aliaa.mamdouh@med.tanta.edu.eg
Lieux d'étude
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Tanta, Egypte
- Recrutement
- Tanta University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- This study included 100 patients with scapular dyskinesis. The patients were divided into 2 groups: one group was treated with ESWT and routine rehabilitation, and the second group was treated with routine rehabilitation only. Adult patients with scapular dyskinesia who exhibited signs of dyskinesia for at least 6 months before enrolment in the study will be selected.
Exclusion Criteria:
- History of shoulder or thorax trauma or surgery.
- The back pain involved the cervical spine and thoracic spine.
- Participants with neurologic deficits
- history of inflammatory conditions such as ankylosing spondylitis
4- Certain situations where shockwave therapy is not recommended. These include:
Absolute contraindications:
- Active infection (i.e., osteomyelitis)
- Malignant tumors, particularly at the treatment site (focused shockwave)
- Pregnancy
Relative Contraindications:
- The brain or nerve in the treatment focus
- Treatment focused on the lungs or pleura
- Significant coagulopathy (increased risk of bleeding, such as haemophilia)
- Epiphyseal plate in treatment focus
Important considerations:
- Cardiac pacemakers or other implantable devices
- Current nonsteroidal anti-inflammatory drug use
- Current anticoagulation use
- Recent corticosteroid injections (receiving a steroid injection into the area to be treated within the previous 12 weeks).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Radial extracorporeal shock wave therapy/ Intervention group
Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (DornierMedTech GmbH, Wessling, Germany) under ultrasound guidance, at periscapular muscles .
1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.
The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month for the treatment group and without operating the machine for the sham group .
No anesthetic oranalgesic drugs will be administered to patients during the therapy session.
Both groups will be put under the same physiotherapeutic program performed by the same well-trained physiatrist.
|
Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (DornierMedTech GmbH, Wessling, Germany) under ultrasound guidance, at periscapular muscles .
1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.
The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month for the treatment group and without operating the machine for the sham group .
No anesthetic oranalgesic drugs will be administered to patients during the therapy session.
Both groups will be put under the same physiotherapeutic program performed by the same well-trained physiatrist.
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Comparateur factice: Sham rESWT/ Control group
Sham rESWT once weekly for one month.
The Dornier AR2 machine (Dornier MedTechGmbH, Wessling, Germany) used under ultrasound guidance, at affested periscapular muscles .
1.500 pulses will be applied by anR20 probe with intensity of 0.10 mJ to0.3mJ/mm2 (2.5 bar) & frequency 4 Hz every week for one month without operating the machine.
|
The Dornier AR2 machine (Dornier MedTechGmbH, Wessling, Germany) used under ultrasound guidance, at affested periscapular muscles .
1.500 pulses will be applied by anR20 probe with intensity of 0.10 mJ to0.3mJ/mm2 (2.5 bar) & frequency 4 Hz every week for one month without operating the machine.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Improvement by Scapular Assistance Test and/or Scapular Dyskinesis Test
Délai: 1 month after intervention
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1 month after intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2026
Achèvement primaire (Estimé)
1 juillet 2026
Achèvement de l'étude (Estimé)
1 juillet 2026
Dates d'inscription aux études
Première soumission
2 juin 2026
Première soumission répondant aux critères de contrôle qualité
2 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 36264PR768/7/24
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Results will be published by the investigators in academic journal.
Délai de partage IPD
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
Extensions will be considered on a case-by-case basis
Critères d'accès au partage IPD
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .