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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial extracorporeal shock wave therapy/ Intervention group | Active Comparator | 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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| Sham rESWT/ Control group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radial extracorporeal shock wave therapy (active comparator) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement by Scapular Assistance Test and/or Scapular Dyskinesis Test | 1 month after intervention |
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Inclusion Criteria:
Exclusion Criteria:
4- Certain situations where shockwave therapy is not recommended. These include:
Absolute contraindications:
Relative Contraindications:
Important considerations:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aliaa Mamdouh Abdelaziz Farag, MD | Contact | 01069468486 | aliaa.mamdouh@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | Egypt |
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.
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
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).
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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 assessments will be done by the first physiatrist (A), who will not be involved in patients' sessions. The randomization will be performed by the second physiatrist (B ) who will not be involved in patients'assessment and ESWT sessions . ESWT Sessions for both groups will be will be carried out by the third physiatrist (C ) who will not take part in the assessments or patients'randomization . Both (C) and (A) were 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.
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| Sham rESWT | Other | 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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