Health TrialsbyHealthPanel

Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome

ConditionCubital Tunnel Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

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

Disqualifiers

Severe cubital tunnel syndrome by McGowan and Dellon classification (fixed intrinsic weakness, significant muscle wasting, or complete sensory loss)

Prior ulnar nerve surgery at the elbow on the affected side

Concomitant peripheral neuropathy (e.g., diabetic neuropathy, Charcot-Marie-Tooth disease) that may confound electrodiagnostic or clinical assessment

Active elbow fracture, dislocation, or other acute traumatic injury to the affected extremity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cubital tunnel release

    Procedure/Surgery

    This surgical intervention occurs without other prior conservative intervention.

  • Conservative Arm

    Procedure/Surgery

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: ConservativeActive comparator 1 intervention
Group B: SurgicalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year

Secondary outcomes

1

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

0 indicates no disability; 100 indicates the most severe disability; "change" refers to differences between each timepoint and the baseline, as well as the differences between each consecutive timepoint

Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
2

Grip strength

Change in grip strength measured with a Jamar dynamometer

Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
3

Pinch strength

Change in lateral, tip, and palmar pinch strength.

Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
4

Two-point discrimination

Change in static and moving sensory discrimination in the ulnar nerve distribution.

Time frame
Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: