Reliability And Validity Of Urdu Version Of Disabilities Of The Arm, Shoulder And Hand Questionnaire

May 6, 2024 updated by: Riphah International University

Reliability And Validity Of Urdu Version Of Disabilities Of The Arm, Shoulder And Hand Questionnaire Among Carpal Tunnel Syndrome Patients

The goal of study is to convert Disabilities Of The Arm, Shoulder And Hand Questionnaire into Urdu and test its reliability and validity among the Pakistani citizens. Also check its correlation with Boston carpal tunnel syndrome questionnaire and visual analogue scale as well.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

A cross-sectional study will be conducted after approval from ethical review committee of Riphah international university of Faisalabad. Total of 90 participants will be included in this study from different community areas, hospitals and rehabilitation centers with carpal tunnel syndrome. 71 of them will be male and 19 will be female. Disabilities of the Arm, Shoulder, and Hand questionnaire will be correlated with Boston carpal tunnel syndrome questionnaire and visual analogue scales. These questionnaires will be filled by participants firstly for baseline, secondly after treatment and third one week later as a follow up. Written informed consents will be taken before filling questionnaires.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Carpal tunnel syndrome population of Pakistan will be included in study.

Description

Inclusion Criteria:

  • Age above 18 years.
  • Subjects with phalen's and Tinnel's test positive.

Exclusion Criteria:

Participants who had following conditions:

  • Diabetes mellitus, thyroid disease, rheumatoid arthritis, radiculopathy of cervical spine, cognitive impairment.
  • Hand surgery within previous 3 months.
  • Difficulty in understanding of language.
  • Musculoskeletal disorder.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disabilities Of The Arm, Shoulder And Hand Questionnaire
Time Frame: 1st day
Disabilities Of The Arm, Shoulder And Hand Questionnaire scale was designed to identify musculoskeletal disorders in the upper limbs, however it is also an appropriate outcome measure for Carpal Tunnel Syndrome. Disabilities Of The Arm, Shoulder And Hand Questionnaire questionnaire has 30 questions. These questions assess how difficult it is to execute a variety of functions due to arm, shoulder, or hand issues (21 items). They also look at intensity of symptoms (5 items), as well as psychological impact of condition (4 items).There are five response possibilities for each item, varying from little difficulty or no symptoms (1 point) to unable to do activity or severe condition (5 points).
1st day
Boston carpal tunnel syndrome questionnaire
Time Frame: 1st day
Boston carpal tunnel syndrome questionnaire is divided into two sub-scales: symptom severity & functional status. Every question has a 5-point scale, with 1 indicating no difficulties and 5 indicating significant symptoms or reduced function. Boston carpal tunnel syndrome questionnaire is a brief questionnaire that may be completed in 10 minutes.
1st day
Visual analogue scale
Time Frame: 1st day
Visual analogue scale is a tool which is used to measure pain severity. It ranges from 0-10 with 0 means no pain ranges between 1 to 3 mean mild pain, 4 to 6 represents moderate pain and 7 to 9 means severe pain whereas 10 means unbearable pain.
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Muhammad Kashif, Riphah International University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC-FSD-00271

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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