- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274570
Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life
The aims of the research are:
- To predict factors affecting hand dysfunction in patient with rheumatoid arthritis
- To study the effect of hand dysfunction on quality of life in patient with rheumatoid arthritis
Study Overview
Status
Conditions
Detailed Description
Rheumatoid Arthritis (RA) is the most common chronic autoimmune systemic inflammatory arthritis, associated with considerable impairments of Quality of life .
Hand is the principle means by which an individual interacts with people and objects in the external environment .Many factors affect hand function in addition to arthritis ,. Many RA patients suffer from an increased loss of muscle mass with a significant impact on these patients' quality of life , and also Distal sensory, mixed sensorimotor, mononeuritis multiplex and entrapment neuropathy are the most commonly reported types of neuropathy in RA .So assessment of factors causing hand dysfunction can provide us a quick and early insight on the debilitating effects of RA on functioning and disability.Thus Early intervention can then be initiated which will help limit joint damage and thereby improve functional outcomes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult Patients who fulfilled the American College of Rheumatology (ACR) (2010) criteria for RA, attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals.
Exclusion Criteria:
- Patients with other rheumatic diseases.
- Patients less than 18 years old.
- Patients with co-morbidities influencing disease activity and hand function (e.g., end- stage liver or renal disease, serious infections, or severe cardiac, respiratory, gastrointestinal disease) .
- Patient with any recent history of hand trauma, or surgery.
- Patient with neurological involvement as , peripheral neuropathy and radiculopathy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: one year
|
Health assessment questionnaire disability index (HAQ)
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hand function
Time Frame: one year
|
measured by musculoskeletal ultrasound
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Safaa A Mahran, professor, Assiut university
- Study Director: Essam Abda, professor, Assiut university
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hand function in RA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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