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

A

Ahram Canadian University

Status

Enrolling

Conditions

Carpal Tunnel Syndrome

Treatments

Diagnostic Test: CTQ-SSS scores

Study type

Observational

Funder types

Other

Identifiers

NCT05838963
012/0023444

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Study Participants
Description:
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.
Treatment:
Diagnostic Test: CTQ-SSS scores

Trial contacts and locations

1

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Central trial contact

Mohamed M ElMeligie, Ph.d

Data sourced from clinicaltrials.gov

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