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Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cubital tunnel syndrome is a condition that occurs when the ulnar nerve, which runs along the inside of the elbow, becomes irritated or compressed. It can cause pain, numbness, tingling, or weakness in the hand and arm. The goal of this clinical trial is to investigate whether early surgery leads to better outcomes than a non-surgical treatment approach using an elbow night splint for mild-to-moderate cubital tunnel syndrome in adults. This study aims to answer the following questions: * Does earlier surgical intervention improve patient-reported pain, symptoms, and function more than treatment with an elbow night splint after one year? * How do symptoms, function, nerve function, and ultrasound findings compare between the two treatments over two years? * How often do people who initially receive treatment with an elbow night splint end up needing surgery? * Researchers will compare early surgery with treatment using an elbow night splint to see how the two approaches affect symptoms and function. Participants will... * be randomly assigned to have surgery or to receive treatment with an elbow night splint. * have a physical examination at each study visit. * have tests of nerve function and ultrasound imaging of the elbow. * answer questionnaires about their symptoms, pain, and arm and hand function. * attend appointments at the start of the study, and at 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Trial Details
NCT Number NCT07862543
Lead Sponsor University of Pittsburgh
Conditions Cubital Tunnel Syndrome
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov