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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05207566
Other study ID # REC/FSD/0292
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date February 28, 2022

Study information

Verified date July 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date February 28, 2022
Est. primary completion date February 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Boston Carpal Tunnel Syndrome Questionnaire 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
Primary Disabilities of the Arm, Shoulder and Hand questionnaire 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
Primary Visual Analog Scale 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
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