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Prevalence of Upper Limb Musculoskeletal Abnormalities in Type 2 Diabetic Patients and Its Relation to Hypoglycemic Control.

Sponsor
Eslam Elsayed Ali Shohda (Other)
Overall Status
Recruiting
CT.gov ID
NCT05819671
Collaborator
(none)
400
Enrollment
1
Location
5.9
Anticipated Duration (Months)
67.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

to investigate prevalence of upper limb musculoskeletal disorders and correlations to glycemic control.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    ). DM is associated with a number of complications including renal disease, peripheral neuropathy, retinopathy, vascular events and musculoskeletal complications. DM is complicated by musculoskeletal problems of upper extremity and particularly the hand, collectively referred as "the diabetic hand." (3) The most common upper limb musculoskeletal disorders associated with DM are adhesive capsulitis, rotator's cuff tendinitis, limited joint mobility (LJM), Dupuytren's disease (DD), trigger finger (TF), and carpal tunnel syndrome (CTS). Upper limb musculoskeletal disorders affect hand functions and activities of daily living (ADL). Aim of the study: to investigate prevalence of upper limb musculoskeletal disorders and correlations to glycemic control.

    Inclusion criteria: patients will be included to this study(cases) if they are:
    1. Diabetic patients. 2) Age > 18 years. 3) Diagnosed as type 2.
    Exclusion criteria:

    Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.

    Sample size calculation: By reviewing literature, it is found that the most relevant study (3) to our work found that the prevalence of upper limb musculoskeletal abnormalities in type 2 diabetic patients is .22 and for control group is .05 so, by using piface calculator (version 1.76) to calculate sample size (power = 0.8, alpha error = 0.05 and beta= 0.2) it is found that we need 71 participants for every group. To increase power of the study will enroll 100 participants for every group.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Upper Limb Musculoskeletal Abnormalities in Type 2 Diabetic Patients and Its Relation to Glycemic Control.
    Actual Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Groupe(A)

    Group (A)diabetics - g
    group(B)

    group B normal is a normal control(non-diabetics)

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of upper limb musculoskeletal disorders and correlations to glycemic control [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients will be included to this study(cases) if they are: 1) Diabetic patients. 2) Age > 18 years. 3) Diagnosed as type 2.
    Exclusion Criteria:
    • Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al ahrar teaching hospital Zagazig Sharkia Egypt 44511

    Sponsors and Collaborators

    • Eslam Elsayed Ali Shohda

    Investigators

    • Principal Investigator: Eslam Dr Shohda, hd,pt, GOTHI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eslam Elsayed Ali Shohda, General Committee of Teaching Hospitals and Institutes, Egypt, General Committee of Teaching Hospitals and Institutes, Egypt
    ClinicalTrials.gov Identifier:
    NCT05819671
    Other Study ID Numbers:
    • HAH00016
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 19, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Musculoskeletal Abnormalities
    Congenital Abnormalities

    Study Results

    No Results Posted as of Apr 19, 2023