Carpal Tunnel SyndromeNCT05411068
Reliability And Validity Of Urdu Version Of Disabilities Of The Arm, Shoulder And Hand Questionnaire
An observational study of Carpal Tunnel Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. 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
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 15 Dec 2023
- 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: Carpal tunnel syndrome population of Pakistan will be included in study.
Who may be able to join
- Age above 18 years.
- Subjects with phalen's and Tinnel's test positive.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Disabilities Of The Arm, Shoulder And Hand Questionnaire, Urdu Version, Reliability, Validity, Carpal Tunnel Syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities Of The Arm, Shoulder And Hand Questionnaire
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).
Measured: 1st day
Boston carpal tunnel syndrome questionnaire
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.
Measured: 1st day
Visual analogue scale
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.
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 posted8 Jun 2022
- Study start30 May 2021
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
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
- 90 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
- NCT05411068
- Sponsor's protocol ID
- REC-FSD-00271
- Status last verified
- May 2024
- First submitted
- 6 Jun 2022
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability And Validity Of Urdu Version Of Disabilities Of The Arm, Shoulder And Hand Questionnaire Among Carpal Tunnel Syndrome Patients
- ClinicalTrials.gov ID
- NCT05411068
- Acronym / sponsor ID
- REC-FSD-00271
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Disabilities Of The Arm, Shoulder And Hand Questionnaire, Urdu Version, Reliability, Validity, Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 8 Jun 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.
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.
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 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
- Carpal tunnel syndrome population of Pakistan will be included in study.
Key inclusion criteria (2 listed)
- Age above 18 years.
- Subjects with phalen's and Tinnel's test positive.
Key exclusion criteria (5 listed)
- 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.
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
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).
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.
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.
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 7 May 2024.
- 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 2 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 7 May 2024. 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?
Disabilities Of The Arm, Shoulder And Hand 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 7 May 2024.