NCT05838976

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

April 20, 2023

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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

Interventions

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 Participants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 3, 2023

Study Start

May 1, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
During the trial and after the trial by 6 months
Access Criteria
via email to mohamed.elmeligie@acu.edu.eg

Locations