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NOT YET RECRUITING
NCT07862543
NA

Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

Summary

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.

Official title: Nonoperative vs. Surgical Decompression for Mild-to-Moderate Cubital Tunnel Syndrome: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2026-10

Completion Date

2030-07

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

PROCEDURE

Cubital tunnel release

This surgical intervention occurs without other prior conservative intervention.

PROCEDURE

Conservative Arm

Conservative management with the option to convert to surgical intervention if conservative measures fail

Locations (7)

UPMC Bethel Park

Bethel Park, Pennsylvania, United States

UPMC Lemieux Sports Complex

Cranberry Township, Pennsylvania, United States

UPMC Passavant

Cranberry Township, Pennsylvania, United States

UPMC East

Monroeville, Pennsylvania, United States

UPMC Montefiore

Pittsburgh, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

UPMC Mercy

Pittsburgh, Pennsylvania, United States