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

NCT05838963 | Unknown

• 1 other identifier: 012/0023444
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Diagnostic Test: CTQ-SSS scores

Interventions

CTQ-SSS scores 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.

Study Participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-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 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.

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 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

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 Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• 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: July 12, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: via email to mohamed.elmeligie@acu.edu.eg

Locations

EG (1)