- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07747454
Isometric Strengthening Exercises Versus Tens in Diabetic Population
30. juli 2026 oppdatert av: Tariq Eisi Alharbi, Kafrelsheikh University
Isometric Strengthening Exercises Versus Tens in Management of Shoulder Pain in Diabetic Population
This study aims to compare the effectiveness of Isometric Strengthening Exercises versus Transcutaneous Electrical Nerve Stimulation in the management of shoulder pain among individuals with diabetes mellitus.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
Shoulder pain is a prevalent musculoskeletal issue in individuals with diabetes, linked to chronic hyperglycemia and altered collagen structure, leading to mobility restrictions and impaired quality of life.
Despite its commonality, there is limited research on specific physiotherapy interventions, particularly isometric strengthening exercises and transcutaneous electrical nerve stimulation.
Investigating these interventions is crucial due to the unique pain thresholds and healing issues in diabetic patients.
This study aims to provide evidence on how isometric exercises and Transcutaneous Electrical Nerve Stimulation influence pain modulation and functional recovery, potentially optimizing rehabilitation strategies.
The findings could support non-pharmacological treatments, reduce reliance on analgesics, and improve patient outcomes in managing shoulder pain in diabetic populations.
Studietype
Intervensjonell
Registrering (Antatt)
75
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tairq Eisi Hedaiban Alharbi, physical therapist
- Telefonnummer: 00966555309550
- E-post: t18t1@hotmail.com
Studiesteder
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Kafr ash Shaykh, Egypt
- Rekruttering
- Out-Patient Clinic, Faculty of Physical Therapy, Kafrelsheikh University
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Ta kontakt med:
- Tairq Eisi Hedaiban Alharbi, physical therapist
- Telefonnummer: 00966555309550
- E-post: t18t1@hotmail.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age between 40-65 years, diagnosed as type 2 diabetes mellitus for at least 5 years
- Clinical diagnosis of unilateral frozen shoulder in the painful or stiff stage.
- Limitation of passive and active range of motion in external rotation, abduction, and flexion.
- Shoulder pain for at least 3 months.
Exclusion Criteria:
- Previous shoulder surgery or fracture.
- Cervical radiculopathy or neurological disorders.
- Rheumatoid arthritis or severe osteoarthritis.
- Cardiac pacemaker.
- Received corticosteroid injection within the last 3 months.
- diabetes mellitus type 1
- Participants with Vitamin B12 or D deficiency
- Osteoarthritis
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Isometric Exercise group
Twenty-five participants will receive the Isometric Exercise in addition to the conventional physical therapy program
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Isometric shoulder exercises include flexion, extension, abduction, internal and external rotation.
The protocol involves holding each position for 10 seconds, resting for 5 seconds, and performing 10 repetitions in 3 sessions per week over 6 weeks.
Each exercise begins from a standing position with the elbow bent at 90 degrees and a towel used for support against a wall or door frame, ensuring minimal movement and maintaining good posture throughout.
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Eksperimentell: Transcutaneous electrical nerve stimulation group
Twenty-five participants will receive Transcutaneous electrical nerve stimulation in addition to a conventional physical therapy program
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Transcutaneous electrical nerve stimulation Application Parameters:
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Aktiv komparator: conventional physical therapy group
Twenty-five participants will receive conventional physical therapy program only
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of shoulder range of motion
Tidsramme: At baseline and after 6 weeks
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Shoulder range of motion (ROM) for flexion, abduction, and external rotation was measured using an electrogoniometer.
Participants were positioned according to standardized measurement procedures, and each movement was assessed within the participant's pain-free range.
Three consecutive measurements were obtained for each motion, and the average value was recorded in degrees (°) for statistical analysis to improve measurement reliability.
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At baseline and after 6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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assessment of pain intensity
Tidsramme: At baseline and after 6 weeks
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In visual analogue scale assessment, patients were asked to place a vertical mark along a horizontal line to indicate their current degree of pain at rest and during activity, where 0 indicated 'no pain' and 100 indicated 'worst pain'.
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At baseline and after 6 weeks
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assessment of activity of daily living of the upper limb
Tidsramme: At baseline and after 6 weeks
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The Disabilities of the Arm, Shoulder, and Hand questionnaire is an outcome measure designed to evaluate upper extremity functionality in daily activities, applicable to various musculoskeletal pathologies.
Comprising 30 items, it measures disability and symptoms by assessing difficulties faced in physical, social, and work-related tasks, as well as their effects on sleep and self-perception regarding upper extremity issues.
Patients respond using a five-point Likert scale, with scores from 1 (no difficulty) to 5 (unable to perform activity).
The Disabilities of the Arm, Shoulder, and Hand questionnaire score ranges from 0 (no disability) to 100 (severest disability), and a score cannot be computed if more than three items are missing.
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At baseline and after 6 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. januar 2027
Datoer for studieregistrering
Først innsendt
30. juli 2026
Først innsendt som oppfylte QC-kriteriene
30. juli 2026
Først lagt ut (Faktiske)
5. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes komplikasjoner
- Motorisk aktivitet
- Bevegelse
- Muskel- og skjelettfysiologiske fenomener
- Muskel- og skjelett og nevrale fysiologiske fenomener
- Terapeutikk
- Fysioterapi -modaliteter
- Rehabilitering
- Anestesi og smertestillende
- Elektrisk stimuleringsbehandling
- Analgesi
- Øvelse
- Transkutan elektrisk nervestimulering
Andre studie-ID-numre
- Tairq_Msc
Legemiddel- og utstyrsinformasjon, studiedokumenter
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