Carpal Tunnel SyndromeNCT05207566
Reliability And Validity Of Urdu Version Of Boston Carpal Tunnel Syndrome Questionnaire
An observational study of Carpal Tunnel Syndrome, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 28 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pakistani population with CTS was included in the study.
Who may be able to join
- Age equal to or above 18 years.
- Absence of any cognitive impairment.
- Patients having positive Tinel and Phalen test.
Who cannot join
- Presence of any of following conditions.
- Diabetes
- Polyneuropathy
- Hypothyroidsm
- Rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Boston Carpal Tunnel Questionnaire, Carpal tunnel syndrome, Cultural adaptation, Validity, Urdu Version, Reliability
- Medical subject headings
- Carpal Tunnel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1st day
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
Measured: 1st day
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).
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start30 May 2021
- Primary completion25 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207566
- Sponsor's protocol ID
- REC/FSD/0292
- Status last verified
- Jul 2022
- First submitted
- 24 Jan 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of Urdu Version of Boston Carpal Tunnel Syndrome Questionnaire : A Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT05207566
- Acronym / sponsor ID
- REC/FSD/0292
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Boston Carpal Tunnel Questionnaire, Carpal tunnel syndrome, Cultural adaptation, Validity, Urdu Version, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Jan 2022 (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.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pakistani population with CTS was included in the study.
Key inclusion criteria (3 listed)
- Age equal to or above 18 years.
- Absence of any cognitive impairment.
- Patients having positive Tinel and Phalen test.
Key exclusion criteria (5 listed)
- Presence of any of following conditions.
- Diabetes
- Polyneuropathy
- Hypothyroidsm
- Rheumatoid arthritis
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
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
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Muhammad Kashif study chair
Riphah International University
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 Carpal Tunnel Syndrome, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jul 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Syndrome Questionnaire (time frame: 1st day). The study lists 3 primary outcomes in all. 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 6 Jul 2022.