Upper Limb Musculoskeletal AbnormalitiesNCT05819671
Prevalence of Upper Limb Musculoskeletal Abnormalities in Type 2 Diabetic Patients and Its Relation to Hypoglycemic Control.
An observational study of Upper Limb Musculoskeletal Abnormalities, run by Eslam Elsayed Ali Shohda at 1 site in Egypt.
Trial summary
to investigate prevalence of upper limb musculoskeletal disorders and correlations to glycemic control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Musculoskeletal Abnormalities
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: diabetics type 2 - comparable control
Who may be able to join
- patients will be included to this study(cases) if they are: 1) Diabetic patients. 2) Age > 18 years. 3) Diagnosed as type 2.
Who cannot join
- Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al ahrar teaching hospital
Zagazig, Sharqia Province, 44511
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Upper Limb Musculoskeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Groupe(A) | Group (A)diabetics - g | |
| group(B) | group B normal is a normal control(non-diabetics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of upper limb musculoskeletal disorders and correlations to glycemic control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Nov 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Musculoskeletal AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eslam Elsayed Ali Shohda
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Eslam Elsayed Ali Shohda, General Committee of Teaching Hospitals and Institutes, Egypt
- Investigators
- Eslam Dr Shohda, hd,pt, Principal investigator, GOTHI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819671
- Sponsor's protocol ID
- HAH00016
- Status last verified
- Dec 2022
- First submitted
- 6 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data only for study researchers and the organization under which the study is conducted
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Upper Limb Musculoskeletal Abnormalities in Type 2 Diabetic Patients and Its Relation to Glycemic Control.
- ClinicalTrials.gov ID
- NCT05819671
- Acronym / sponsor ID
- HAH00016
- Conditions
- Upper Limb Musculoskeletal Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Eslam Elsayed Ali ShohdaOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groupe(A) | – | –Group (A)diabetics - g |
| group(B) | – | –group B normal is a normal control(non-diabetics) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- diabetics type 2 - comparable control
Key inclusion criteria (1 listed)
- patients will be included to this study(cases) if they are: 1) Diabetic patients. 2) Age > 18 years. 3) Diagnosed as type 2.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of upper limb musculoskeletal disorders and correlations to glycemic control
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No. data only for study researchers and the organization under which the study is conducted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eslam Dr Shohda, hd,pt principal investigator
GOTHI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Musculoskeletal Abnormalities, run by Eslam Elsayed Ali Shohda at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam Elsayed Shohda, PHD,PT (01009482231, dreslamelsayed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of upper limb musculoskeletal disorders and correlations to glycemic control (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.