NCT07633340

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jun 2026Jul 2026

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 2, 2026

Last Update Submit

June 6, 2026

Conditions

Keywords

Scapular dyskinesis

Outcome Measures

Primary Outcomes (1)

  • Improvement by Scapular Assistance Test and/or Scapular Dyskinesis Test

    1 month after intervention

Study Arms (2)

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.

Device: Radial extracorporeal shock wave therapy (active comparator)

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.

Other: Sham rESWT

Interventions

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/ Intervention group

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.

Sham rESWT/ Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

RECRUITING

Central Study Contacts

Aliaa Mamdouh Abdelaziz Farag, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
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 Criteria
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).

Locations