Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome

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 bracing, to surgical intervention, including in-situ decompression and ulnar nerve transposition. For mild-to-moderate disease, the current standard of care is an initial trial of conservative management with elbow night splinting, with surgical intervention reserved for patients who do not improve or whose symptoms progress. However, the comparative effectiveness of this staged approach versus early surgical intervention has not been rigorously evaluated in a prospective, randomized trial. Additionally, objective measures of ulnar nerve structure and function have not been systematically correlated with clinical and patient-reported outcomes across treatment approaches.

Study Objective This study aims to address this gap by prospectively comparing initial conservative management with early surgical intervention for mild-to-moderate cubital tunnel syndrome. Participants will be followed for two years to evaluate clinical, functional, imaging, electrodiagnostic, and patient-reported outcomes and to assess the frequency and timing of conversion from conservative to surgical management.

Study Design This is a prospective, single-center, randomized controlled trial. Eligible participants will be randomly assigned in a 1:1 ratio to either conservative management with elbow night splinting or early surgical intervention.

Randomization will be performed using a computer-generated block randomization scheme with variable block sizes, stratified by disease severity (mild vs. moderate per Dellon classification). The allocation sequence will be concealed in sequentially numbered, opaque, sealed envelopes opened at the time of enrollment.

Patient Population Adults with mild-to-moderate cubital tunnel syndrome who meet the study eligibility criteria will be considered for enrollment. Participants must be able to provide informed consent and comply with study procedures and follow-up. Patients with severe disease, prior ulnar nerve surgery on the affected side, conditions that could substantially confound assessment of ulnar nerve function, acute traumatic conditions of the affected extremity, or other protocol-defined exclusion criteria will not be eligible.