Prevalence of Upper Limb Musculoskeletal Abnormalities in... | NCT05819671

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

NCT05819671

Sponsor

Eslam Elsayed Ali Shohda

Status

Unknown status

Last Update Posted

Apr 19, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Upper Limb Musculoskeletal Abnormalities

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

May 2023Estimated

Completion Date

May 2023Estimated

First Submitted Date

Apr 6, 2023

First Submission Date that Met QC Criteria

Apr 6, 2023

First Posted Date

Apr 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2023

Last Update Posted Date

Apr 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eslam Elsayed Ali Shohda, General Committee of Teaching Hospitals and Institutes, Egypt, General Committee of Teaching Hospitals and Institutes, EgyptSponsor-Investigator

Lead Sponsor

Eslam Elsayed Ali ShohdaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Groupe(A)		Group (A)diabetics - g
group(B)		group B normal is a normal control(non-diabetics)

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

diabetics type 2 - comparable control

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eslam Elsayed Shohda, PHD,PT	Contact	01009482231		dreslamelsayed@hotmail.com
Hadder Khaled Abd elhameed, DPT	Contact	01112663032		dreslamelsayed@hotmail.com

Overall Officials

Name	Affiliation	Role
Eslam Dr Shohda, hd,pt	GOTHI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al ahrar teaching hospital	Recruiting	Zagazig	Sharqia Province	44511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided