University of Pittsburgh
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.
Background and Rationale Cubital tunnel syndrome (CuTS) is the second most common peripheral nerve compression syndrome of the upper extremity after carpal tunnel syndrome. It results from compression or traction of the ulnar nerve at the elbow, most commonly at the cubital tunnel retinaculum or the aponeurosis of the flexor carpi ulnaris. Clinical manifestations include paresthesias and numbness in the ring and small fingers, intrinsic hand weakness, and pain along the medial elbow. Current management strategies range from conservative measures, such as activity modification and elbow bracin…
Inclusion Criteria: * Age 18 years or older * Mild-to-moderate severity based on McGowan and Dellon classification: * Mild: Purely sensory symptoms without motor deficit or intrinsic atrophy * Moderate: Sensory symptoms with mild motor weakness (grip or pinch) without fixed clawing or significant intrinsic wasting * Symptom duration of at least 6 weeks * Willing and able to comply with follow-up schedule, study procedures, and splinting protocol if randomized to conservative management * Able to provide written informed consent Exclusion Criteria: * Severe cubital tunnel syndrome by Mc…
This surgical intervention occurs without other prior conservative intervention.
Conservative management with the option to convert to surgical intervention if conservative measures fail