Cubital Tunnel SyndromeNCT07862543
Comparing Surgical and Nonsurgical Outcomes of Cubital Tunnel Syndrome
A study testing Cubital tunnel release and Conservative Arm in people with Cubital Tunnel Syndrome, run by University of Pittsburgh at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- Cubital tunnel release and Conservative Arm
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Known space-occupying lesion at the cubital tunnel (e.g., ganglion cyst, lipoma, bony spur) identified on prior imaging
- Inflammatory arthropathy affecting the elbow (e.g., rheumatoid arthritis)
Show all 9Show fewer
- Pregnancy
- Inability to comply with follow-up visits or complete patient-reported outcome instruments
- Concurrent participation in another interventional study affecting upper extremity function
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
UPMC Bethel Park
Bethel Park, Pennsylvania, 15102
Michael P Chen, MD, 4258919823, chenmp@upmc.edu
UPMC Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066
Michael P Chen, 39, 4258919823, chenmp@upmc.edu
UPMC Passavant
Cranberry Township, Pennsylvania, 16066
Michael P Chen, MD, 4258919823, chenmp@upmc.edu
UPMC East
Monroeville, Pennsylvania, 15146
Michael P Chen, MD, 4258919823, chenmp@upmc.edu
UPMC Montefiore
Pittsburgh, Pennsylvania, 15213
Michael P Chen, MD, 4258919823, chenmp@upmc.edu
UPMC
Pittsburgh, Pennsylvania, 15213
Michael P Chen, MD, 4258919823, chenmp@upmc.edu
UPMC Mercy
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Nonoperative vs. Surgical Decompression for Mild-to-Moderate Cubital Tunnel Syndrome: A Prospective Randomized Controlled 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- Cubital tunnel release, Conservative Arm
- Keywords
- cubital tunnel, randomized trial
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cubital tunnel releaseProcedure or surgery
Also called ulnar nerve decompression
This surgical intervention occurs without other prior conservative intervention.
Conservative ArmProcedure or surgery
Also called night splinting, activity modification, anti-inflammatory medications, physical therapy
Conservative management with the option to convert to surgical intervention if conservative measures fail
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Active comparator | Conservative management of cubital tunnel syndrome with option to convert to surgical management Receives: Procedure: Conservative Arm |
| Surgical | Experimental | Surgical management of cubital tunnel syndrome Receives: Procedure: Cubital tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (18)
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
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip strength
Change in grip strength measured with a Jamar dynamometer
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pinch strength
Change in lateral, tip, and palmar pinch strength.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Two-point discrimination
Change in static and moving sensory discrimination in the ulnar nerve distribution.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Semmes-Weinstein monofilament threshold
Change in sensory threshold in the ulnar nerve distribution.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Ulnar nerve cross-sectional area
Change in ultrasound-measured ulnar nerve size at the cubital tunnel.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Ulnar nerve conduction velocity
Change in sensory and motor conduction velocity across the elbow.
Measured: Baseline and 1 year
Electrodiagnostic severity grade
Change in overall electrodiagnostic severity classified as normal, mild, moderate, or severe.
Measured: Baseline and 1 year
McGowan/Dellon grade
Change in clinical severity classification of cubital tunnel syndrome.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Rate of Surgical Conversion
Proportion of participants in the conservative arm who proceed to surgical treatment.
Measured: From initiation of conservative treatment through 6 months of treatment
Time to conversion
Time from initiation of conservative treatment to surgical conversion
Measured: From initiation of conservative treatment through 6 months of treatment
Patient satisfaction
Participant-reported satisfaction with treatment outcome using a 5-point Likert scale (minimum 1; maximum 5; higher score indicates greater satisfaction)
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Global Rating of Change
Participant-reported overall change in symptoms and function (minimum -3 indicating much worse; maximum +3 indicating much better)
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Return to work
Time required to return to work following surgical treatment.
Measured: From surgery until return to work or two years after enrollment, whichever comes first
Return to full activity
Time required to resume full activity following surgical treatment
Measured: From surgery until return to full activity or two years after enrollment, whichever comes first
Complication rate
Occurrence of treatment-related complications
Measured: From treatment initiation through 2 years after enrollment
Reoperation rate
Occurrence of revision or repeat surgical treatment
Measured: From initial surgery through 2 years after enrollment
PRUNE clinically meaningful improvement
Change in PRUNE score corresponding to meaningful patient-reported improvement, determined using patient satisfaction and Global Rating of Change at 1 year as anchors. Patients reporting "satisfied" or "very satisfied" and/or positive change will be considered meaningfully improved, and ROC analysis will be used to identify the PRUNE change threshold that best distinguishes meaningful improvement from non-meaningful improvement.
Measured: From enrollment to 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Fowler, University of Pittsburgh
- Investigators
- John R Fowler, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862543
- Sponsor's protocol ID
- STUDY26060110
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with outside researchers to preserve participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonoperative vs. Surgical Decompression for Mild-to-Moderate Cubital Tunnel Syndrome: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07862543
- Acronym / sponsor ID
- STUDY26060110
- Conditions
- Cubital Tunnel Syndrome
- Keywords
- cubital tunnel, randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | Active comparator | Procedure: Conservative ArmConservative management of cubital tunnel syndrome with option to convert to surgical management |
| Surgical | Experimental | Procedure: Cubital tunnel releaseSurgical management of cubital tunnel syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Mild-to-moderate severity based on McGowan and Dellon classification:
- 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
Key exclusion criteria (9 listed)
- 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
- Known space-occupying lesion at the cubital tunnel (e.g., ganglion cyst, lipoma, bony spur) identified on prior imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cubital tunnel releaseAlso: ulnar nerve decompressionThis surgical intervention occurs without other prior conservative intervention. | Procedure or surgery | Surgical |
| Conservative ArmAlso: night splinting, activity modification, anti-inflammatory medications, physical therapyConservative management with the option to convert to surgical intervention if conservative measures fail | Procedure or surgery | Conservative |
Primary outcome
Change in Patient-Rated Ulnar Nerve Evaluation (PRUNE) Score from baseline to 1 year
Time frame: Baseline, 6 weeks, 3 months, 6 months, 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
18 secondary outcomes
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
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Grip strength
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pinch strength
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Two-point discrimination
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Semmes-Weinstein monofilament threshold
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Ulnar nerve cross-sectional area
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Ulnar nerve conduction velocity
Time frame: Baseline and 1 year
Electrodiagnostic severity grade
Time frame: Baseline and 1 year
McGowan/Dellon grade
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Rate of Surgical Conversion
Time frame: From initiation of conservative treatment through 6 months of treatment
Time to conversion
Time frame: From initiation of conservative treatment through 6 months of treatment
Patient satisfaction
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Global Rating of Change
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Return to work
Time frame: From surgery until return to work or two years after enrollment, whichever comes first
Return to full activity
Time frame: From surgery until return to full activity or two years after enrollment, whichever comes first
Complication rate
Time frame: From treatment initiation through 2 years after enrollment
Reoperation rate
Time frame: From initial surgery through 2 years after enrollment
PRUNE clinically meaningful improvement
Time frame: From enrollment to 1 year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with outside researchers to preserve participant privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John R Fowler, MD principal investigator
University of Pittsburgh Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cubital tunnel release and Conservative Arm in people with Cubital Tunnel Syndrome, run by University of Pittsburgh at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John R Fowler, MD (412-605-3245, fowlerjr@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Rated Ulnar Nerve Evaluation (PRUNE) Score from baseline to 1 year (time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.