- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07633340
Routine Rehabilitation Versus Shock Wave Therapy for Scapular Dyskinesis
Routine Rehabilitation Versus Shock Wave Therapy for Patients With Scapular Dyskinesis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Tanta, Egypten
- Tanta University
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
|
|
Sham-komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Improvement by Scapular Assistance Test and/or Scapular Dyskinesis Test
Tidsramme: 1 month after intervention
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1 month after intervention
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 36264PR768/7/24
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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