Nonoperative vs. Surgical Decompression for Mild-to-Moderate Cubital Tunnel Syndrome: A Prospective Randomized Controlled Trial
Sponsor study identifier
interventional
220
1 country
7
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 8, 2026
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 7, 2026
Actual (reported)July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Patient-Rated Ulnar Nerve Evaluation (PRUNE) Score from baseline to 1 year
0 indicates no symptoms or functional deficits; 100 indicates worst possible symptoms and functional deficits; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint
Baseline, 6 weeks, 3 months, 6 months, 1 year
Change in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at Each Timepoint; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip strength
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pinch strength
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Two-point discrimination
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Semmes-Weinstein monofilament threshold
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Conservative management of cubital tunnel syndrome with option to convert to surgical management
Surgical management of cubital tunnel syndrome
This surgical intervention occurs without other prior conservative intervention.
Conservative management with the option to convert to surgical intervention if conservative measures fail
UPMC Bethel Park
Bethel Park, Pennsylvania, 15102, United States
UPMC Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066, United States
UPMC Passavant
Cranberry Township, Pennsylvania, 16066, United States
John R Fowler, MD
University of Pittsburgh Medical Center
First Submitted
September 8, 2026
First Posted
October 7, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 2028
Presence of the Arcade of Struthers on Preoperative Ultrasound
Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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UPMC East
Monroeville, Pennsylvania, 15146, United States
UPMC Montefiore
Pittsburgh, Pennsylvania, 15213, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
UPMC Mercy
Pittsburgh, Pennsylvania, 15219, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2026
Record last verified: 2026-10
Individual participant data will not be shared with outside researchers to preserve participant privacy and confidentiality.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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