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

NCT ID: NCT05838963

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2024-11-01

Brief 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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Participants

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.

CTQ-SSS scores

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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:

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed M ElMeligie, Ph.d

Role: CONTACT

mohamed.elmeligie@acu.edu.eg

+201064442032

Facility Contacts

Mohamed M ElMeligie, Ph.d

Role: primary

mohamed.elmeligie@acu.edu.eg

01064442032

Other Identifiers

012/0023444

Identifier Type: -

Identifier Source: org_study_id