- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07747454
Isometric Strengthening Exercises Versus Tens in Diabetic Population
30 juli 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
75
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Tairq Eisi Hedaiban Alharbi, physical therapist
- Telefonnummer: 00966555309550
- E-post: t18t1@hotmail.com
Studieorter
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Kafr ash Shaykh, Egypten
- Rekrytering
- Out-Patient Clinic, Faculty of Physical Therapy, Kafrelsheikh University
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Kontakt:
- Tairq Eisi Hedaiban Alharbi, physical therapist
- Telefonnummer: 00966555309550
- E-post: t18t1@hotmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Assessment of shoulder range of motion
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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assessment of pain intensity
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 januari 2027
Studieregistreringsdatum
Först inskickad
30 juli 2026
Först inskickad som uppfyllde QC-kriterierna
30 juli 2026
Första postat (Faktisk)
5 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Diabetes mellitus
- Diabeteskomplikationer
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Terapeutik
- Fysioterapimetoder
- Rehabilitering
- Anestesi och analgesi
- Elektrisk stimuleringsterapi
- Analgesi
- Utöva
- Transkutan elektrisk nervstimulering
Andra studie-ID-nummer
- Tairq_Msc
Läkemedels- och apparatinformation, studiedokument
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