- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05207566
Reliability And Validity Of Urdu Version Of Boston Carpal Tunnel Syndrome Questionnaire
July 4, 2022 updated by: Riphah International University
Psychometric Properties of Urdu Version of Boston Carpal Tunnel Syndrome Questionnaire : A Reliability and Validity Study
Translate and culturally adapt Boston Carpal Tunnel Syndrome Questionnaire into Urdu language and find its reliability and validity in Pakistani Carpal Tunnel Syndrome patients To check its correlation with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale.
Study Overview
Status
Completed
Conditions
Detailed Description
The original version of Boston Carpal Tunnel Syndrome Questionnaire will be translated into Urdu.
Among idiopathic Carpal Tunnel Syndrome, 110 patients will be included in the study by convenience sampling.
The selection of the patients will be done according to the criteria.
Boston Carpal Tunnel Syndrome Questionnaire will be correlated with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale and these questionnaires will be provided three times to a single patient for their assessment.
Firstly, they will be provided prior to treatment and secondly just after having treatment.
Thirdly, they will be given after seven days of treatment.
Internal consistency and reproducibility will be used to determine reliability.
Boston Carpal Tunnel Syndrome Questionnaire will be correlated with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale to assess validity.
From each patient informed consent will be obtained.
Statistical Package of Social Sciences software, version 24 will be used for the analysis of data.
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
-
Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pakistani population with CTS was included in the study.
Description
Inclusion Criteria:
- Age equal to or above 18 years.
- Absence of any cognitive impairment.
- Patients having positive Tinel and Phalen test.
Exclusion Criteria:
Presence of any of following conditions.
- Diabetes
- Polyneuropathy
- Hypothyroidsm
- Rheumatoid arthritis
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Boston Carpal Tunnel Syndrome Questionnaire
Time Frame: 1st day
|
Boston Carpal Tunnel Syndrome Questionnaireconsists of 2 subscales i.e: symptom severity & functional status.The former contains 11 items for assessing several symptoms while later contains 8 items of daily functional activities.
Every item consists of 5 point score with 1 meaning no difficulty while 5 refers to severe symptoms.
Boston Carpal Tunnel Syndrome Questionnaire is a short questionnaire and is completed within ten minutes
|
1st day
|
Disabilities of the Arm, Shoulder and Hand questionnaire
Time Frame: 1st day
|
Disabilities of the Arm, Shoulder and Hand questionnaire was developed for use in problems like musculoskeletal in upper limbs.
It has been translated into various languages.
It consists of 30 items used to assess physical and psychosocial aspects.
Every items consists of 5 point score with 1 meaning no difficulty while 5 refers to unable
|
1st day
|
Visual Analog Scale
Time Frame: 1st day
|
VAS is used to evaluate pain and consists of a scale with 0 to 10 readings (0 meaning no pain and 10 meanings unbearable pain).
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 30, 2021
Primary Completion (Actual)
February 25, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
January 24, 2022
First Submitted That Met QC Criteria
January 24, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 4, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/FSD/0292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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