NCT05838963|Unknown
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Sponsor study identifier
observational
200
1 country
1
Study Start
July 12, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 1, 2024
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Study Completion
November 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims to determine the predictive value of baseline CTQ-SSS scores for progression to carpal tunnel release (CTR) surgery in patients with carpal tunnel syndrome (CTS). It will be a prospective cohort study involving at least 200 patients with CTS who are undergoing nonsurgical management. Participants will complete the CTQ-SSS and other functional measures at baseline, 3 months, 6 months, and 12 months, and the primary outcome will be progression to CTR surgery. Logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for progression to CTR surgery, adjusting for potential confounding factors such as age, sex, and baseline symptom severity. The results of this study can help clinicians identify patients who may benefit from early surgical intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2023
Actual (reported)May 3, 2023
Actual (reported)July 12, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 1, 2024
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November 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Predictive value of baseline CTQ-SSS scores for progression to carpal tunnel release (CTR) surgery.
To determine the predictive value of baseline CTQ-SSS scores for progression to CTR surgery in patients with carpal tunnel syndrome undergoing nonsurgical management
Participants will be followed up for a 12-month period.
This group will consist of at least 200 patients with carpal tunnel syndrome who are undergoing nonsurgical management. Participants will complete the CTQ-SSS and other functional measures at baseline, 3 months, 6 months, and 12 months. The primary outcome will be progression to carpal tunnel release (CTR) surgery. Logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for progression to CTR surgery, adjusting for potential confounding factors such as age, sex, and baseline symptom severity. The results of this study can help clinicians identify patients who may benefit from early surgical intervention.
The CTQ-SSS is a self-reported questionnaire that measures the severity of symptoms related to carpal tunnel syndrome, including pain, numbness, tingling, and weakness in the hand and wrist. Participants in this study will complete the CTQ-SSS and other functional measures that include: 1. demographic information 2. hand dominance 3. Boston Carpal Tunnel Questionnaire (BCTQ) 4. nerve conduction studies (NCS) to measure median nerve conduction velocity (NCV), distal motor latency (DML), and sensory nerve action potential (SNAP) amplitude, Compound muscle action potential (CMAP) amplitude. 5. Hand grip strength Outcomes will be measured at baseline, 3 months, 6 months, and 12 months. The primary outcome will be progression to carpal tunnel release surgery, and logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for this outcome, adjusted for potential confounding factors such as age, sex, and baseline symptom severity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population will consist of patients with carpal tunnel syndrome who are undergoing nonsurgical management.
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt
Amal Fawzy, Ph.d
Faculty of Physical Therapy, Ahram Canadian University
First Submitted
April 20, 2023
First Posted
May 3, 2023
Study Start
July 12, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Hand Function Tests in Carpal Tunnel Syndrome: A Cross-sectional Study
Contact the study team to confirm eligibility.
November 1, 2024
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 6, 2023
Record last verified: 2023-07
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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Source: ClinicalTrials.gov.
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