Carpal Tunnel SyndromeNCT05838976
Validity and Reliability of CTQ-SSS in Carpal Tunnel Syndrome.
An observational study of Carpal Tunnel Syndrome, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
To determine the validity and reliability of the shorter version of the CTQ-SSS in patients with carpal tunnel syndrome (CTS) undergoing nonsurgical management. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Shorter Version of the CTQ-SSS
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to Oct 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of patients with carpal tunnel syndrome who are undergoing nonsurgical management.
Who may be able to join
- Patients diagnosed with carpal tunnel syndrome based on clinical presentation and/or nerve conduction studies.
- Patients aged 18 years to 60 years old.
- Patients who are undergoing nonsurgical management for carpal tunnel syndrome.
Who cannot join
- Patients with a history of hand or wrist surgery within the past 6 months.
- Patients with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
- Patients with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
- Patients with any other medical condition that could affect hand function or interfere with test completion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Validity and Reliability of the Shorter Version of the CTQ-SSS in Patients With Carpal Tunnel Syndrome: A Cross-sectional Study
To determine the validity and reliability of the shorter version of the CTQ-SSS in patients with carpal tunnel syndrome (CTS) undergoing nonsurgical management.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Shorter Version of the CTQ-SSS
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shorter Version of the CTQ-SSSDiagnostic test
The intervention in this study is the administration of the shorter version of the CTQ-SSS, a validated questionnaire designed to assess the severity of symptoms and functional limitations associated with carpal tunnel syndrome. The CTQ-SSS consists of 8 items related to symptom severity and 2 items related to functional status. The scores for each set of items are combined to generate symptom severity and functional status scores, which will be used to assess the validity and reliability of the CTQ-SSS in patients with carpal tunnel syndrome undergoing nonsurgical management.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | This group will consist of at least 50 patients with carpal tunnel syndrome who are undergoing nonsurgical management. Participants will complete the shorter version of the CTQ-SSS and other functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the Patient-Rated Wrist Evaluation (PRWE). The validity and reliability of the CTQ-SSS will be assessed in this group using test-retest reliability and internal consistency analyses, as well as construct validity analyses comparing CTQ-SSS scores with other functional measures. Receives: Diagnostic Test: Shorter Version of the CTQ-SSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and Reliability of the Shorter Version of the CTQ-SSS
To determine the validity and reliability of the shorter version of the CTQ-SSS in patients with carpal tunnel syndrome undergoing nonsurgical management. The CTQ-SSS will be administered at baseline and at a follow-up visit within 2-4 weeks to assess test-retest reliability. Internal consistency will be assessed using Cronbach's alpha coefficient. Construct validity will be assessed by comparing the CTQ-SSS scores with other functional measures such as the DASH questionnaire and PRWE using Pearson's correlation coefficient.
Measured: Outcome measures will be assessed within 2-4 weeks of the initial CTQ-SSS administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study startMay 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838976
- Sponsor's protocol ID
- 012/00X0021
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Shorter Version of the CTQ-SSS in Patients With Carpal Tunnel Syndrome: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05838976
- Acronym / sponsor ID
- 012/00X0021
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 3 May 2023 (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.
To determine the validity and reliability of the shorter version of the CTQ-SSS in patients with carpal tunnel syndrome (CTS) undergoing nonsurgical management.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Diagnostic Test: Shorter Version of the CTQ-SSSThis group will consist of at least 50 patients with carpal tunnel syndrome who are undergoing nonsurgical management. Participants will complete the shorter version of the CTQ-SSS and other functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the Patient-Rated Wrist Evaluation (PRWE). The validity and reliability of the CTQ-SSS will be assessed in this group using test-retest reliability and internal consistency analyses, as well as construct validity analyses comparing CTQ-SSS scores with other functional measures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of patients with carpal tunnel syndrome who are undergoing nonsurgical management.
Key inclusion criteria (3 listed)
- Patients diagnosed with carpal tunnel syndrome based on clinical presentation and/or nerve conduction studies.
- Patients aged 18 years to 60 years old.
- Patients who are undergoing nonsurgical management for carpal tunnel syndrome.
Key exclusion criteria (4 listed)
- Patients with a history of hand or wrist surgery within the past 6 months.
- Patients with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
- Patients with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
- Patients with any other medical condition that could affect hand function or interfere with test completion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shorter Version of the CTQ-SSSThe intervention in this study is the administration of the shorter version of the CTQ-SSS, a validated questionnaire designed to assess the severity of symptoms and functional limitations associated with carpal tunnel syndrome. The CTQ-SSS consists of 8 items related to symptom severity and 2 items related to functional status. The scores for each set of items are combined to generate symptom severity and functional status scores, which will be used to assess the validity and reliability of the CTQ-SSS in patients with carpal tunnel syndrome undergoing nonsurgical management. | Diagnostic test | Study Participants |
Primary outcome
Validity and Reliability of the Shorter Version of the CTQ-SSS
Time frame: Outcome measures will be assessed within 2-4 weeks of the initial CTQ-SSS administration.
To determine the validity and reliability of the shorter version of the CTQ-SSS in patients with carpal tunnel syndrome undergoing nonsurgical management. The CTQ-SSS will be administered at baseline and at a follow-up visit within 2-4 weeks to assess test-retest reliability. Internal consistency will be assessed using Cronbach's alpha coefficient. Construct validity will be assessed by comparing the CTQ-SSS scores with other functional measures such as the DASH questionnaire and PRWE using Pearson's correlation coefficient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
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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.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian 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 Ahram Canadian University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 3 May 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and Reliability of the Shorter Version of the CTQ-SSS (time frame: Outcome measures will be assessed within 2-4 weeks of the initial CTQ-SSS administration.). 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 3 May 2023.