Routine Rehabilitation Versus Shock Wave Therapy for Scapular Dyskinesis

Official title

Routine Rehabilitation Versus Shock Wave Therapy for Patients With Scapular Dyskinesis

Overview

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.

Detailed description

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.

Interventions

• Device Radial extracorporeal shock wave therapy (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
• Other Sham rESWT
  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.

Primary outcome measures

• Improvement by Scapular Assistance Test and/or Scapular Dyskinesis Test [Time frame: 1 month after intervention]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Tanta University — Tanta

Identifiers

NCT: NCT07633340 · 36264PR768/7/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗