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

April 6, 2023 updated by: Eslam Elsayed Ali Shohda

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44511
        • Recruiting
        • Al ahrar teaching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

diabetics type 2 - comparable control

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Groupe(A)
Group (A)diabetics - g
group(B)
group B normal is a normal control(non-diabetics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of upper limb musculoskeletal disorders and correlations to glycemic control
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eslam Elsayed Ali Shohda

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAH00016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data only for study researchers and the organization under which the study is conducted

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe