Predictive Value of Baseline CTQ-SSS Scores for Progression to Carpal Tunnel Release Surgery: A Cohort Study

Carpal Tunnel Syndrome Clinical Trial

Official title:

Predictive Value of Baseline CTQ-SSS Scores for Progression to Carpal Tunnel Release Surgery: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838963
• Other study ID #: 012/0023444
• Status: Recruiting
• Start date: July 12, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: July 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with symptoms consistent with carpal tunnel syndrome, such as numbness, tingling, or pain in the hand or wrist.

• Patients with a positive nerve conduction study confirming carpal tunnel syndrome, OR patients with clinical symptoms and signs consistent with carpal tunnel syndrome if a nerve conduction study is not available or inconclusive.

• Patients who have not undergone hand or wrist surgery within the past 6 months.

• Patients who are 18 years of age or older.

• Patients who are willing and able to provide informed consent and comply with study requirements.

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 other neurologic or musculoskeletal disorders that could affect hand function or interfere with test completion.

• Pregnant or breastfeeding women.

• Patients who have participated in another clinical trial within the past 30 days.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Diagnostic Test:
• CTQ-SSS scores
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: demographic information hand dominance Boston Carpal Tunnel Questionnaire (BCTQ) 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. 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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.