- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07747454
Isometric Strengthening Exercises Versus Tens in Diabetic Population
30. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
75
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tairq Eisi Hedaiban Alharbi, physical therapist
- Telefonnummer: 00966555309550
- E-mail: t18t1@hotmail.com
Studiesteder
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Kafr ash Shaykh, Egypten
- Rekruttering
- Out-Patient Clinic, Faculty of Physical Therapy, Kafrelsheikh University
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Kontakt:
- Tairq Eisi Hedaiban Alharbi, physical therapist
- Telefonnummer: 00966555309550
- E-mail: t18t1@hotmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. januar 2027
Datoer for studieregistrering
Først indsendt
30. juli 2026
Først indsendt, der opfyldte QC-kriterier
30. juli 2026
Først opslået (Faktiske)
5. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes komplikationer
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Rehabilitering
- Anæstesi og analgesi
- Elektrisk stimuleringsterapi
- Analgesi
- Øvelse
- Transkutan elektrisk nervestimulering
Andre undersøgelses-id-numre
- Tairq_Msc
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