Validity and Reliability of CTQ-SSS in Carpal Tunnel Syndrome.

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Diagnostic test: Shorter Version of the CTQ-SSS

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with carpal tunnel syndrome who are undergoing nonsurgical management.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Shorter Version of the CTQ-SSS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Outcome measures will be assessed within 2-4 weeks of the initial CTQ-SSS administration.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 012/00X0021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: During the trial and after the trial by 6 months
• IPD Sharing Access Criteria: via email to mohamed.elmeligie@acu.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No