Neuropathy UlnarNCT04254185
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
A study testing Simple decompression and Subcutaneous anterior transposition in people with Neuropathy Ulnar, run by University of Michigan at 10 sites in United States.
Trial summary
This research is studying two surgical procedures in a large group of people to learn about how well these procedures work as a treatment for ulnar neuropathy at the elbow (UNE). Researchers want to see which surgery is more helpful for people with ulnar neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy Ulnar
- What is being tested?
- Simple decompression and Subcutaneous anterior transposition
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Feb 2020to 31 Oct 2027
- 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
- A clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow
- Confirmation of ulnar neuropathy using the American Association of Electrodiagnostic Medicine criteria for electrodiagnostic studies at the elbow. (Participants must meet at least 1 of the criteria to be enrolled (absolute motor nerve conduction from above elbow (AE) to below elbow (BE) of less than 50 m/s; An AE to BE segment greater than 10 m/s slower than BE to wrist segment; A decrease in compound muscle action potential (CMAP) negative peak amplitude from BE to AE greater than 20%)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Able to read, understand and complete the questionnaires in English
Who cannot join
- Previous elbow fracture requiring surgical fixation
- Patients who have not attempted conservative management for UNE (e.g. night splinting)
- Subluxation of ulnar nerve on preoperative exam
- Recurrent UNE after previous surgery
- Concomitant neuropathic conditions such as Carpal Tunnel Syndrome or cervical or brachial plexus abnormalities
- Participants with severe comorbid conditions that prohibit surgery
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Michigan Medicine
Ann Arbor, Michigan, 48109
Emory Healthcare
Atlanta, Georgia, 30329
Johns Hopkins University
Baltimore, Maryland, 21093
Curtis National Hand Center
Baltimore, Maryland, 21218
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
Ohio State University
Columbus, Ohio, 43210
Norton Healthcare
Louisville, Kentucky, 40241
University of Oklahoma
Oklahoma City, Oklahoma, 73126
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
This research is studying two surgical procedures in a large group of people to learn about how well these procedures work as a treatment for ulnar neuropathy at the elbow (UNE). Researchers want to see which surgery is more helpful for people with ulnar neuropathy. This research will determine if one surgery is better than the other to alleviate symptoms.
- Conditions
- Neuropathy Ulnar
- Being tested
- Simple decompression, Subcutaneous anterior transposition
- Keywords
- Decompression, Anterior Subcutaneous Transposition, Elbow, Ulnar Nerve
- Medical subject headings
- Ulnar Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple decompressionProcedure or surgery
Also called In-situ Decompression
Surgical technique
Subcutaneous anterior transpositionProcedure or surgery
Surgical technique
| Study group | Role | What they receive |
|---|---|---|
| Simple decompression | Active comparator | In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve. Receives: Procedure: Simple decompression |
| Subcutaneous anterior transposition | Active comparator | Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation Receives: Procedure: Subcutaneous anterior transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score
The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales assessing overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. Scores range from 0-100, 100=no disability). In the pain scale, however, high scores indicate greater pain (0-100, 0=no pain).
Measured: 1 year
Secondary outcomes (9)
Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score
The MHQ is a self-report measure that assesses the function of hand(s) and/or wrist(s). The MHQ contains six distinct scales. The score will be measured at various time points to identify the recovery trend.In a pain scale, high scores indicate greater pain (0-100, 0=no pain)
Measured: Up to 1 year
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score
The CTQ (also known as the Levine Questionnaire, Boston Questionnaire, and the Brigham and Women's Questionnaire) contains 19 questions (11 symptom severity questions and 8 functional status questions). All questions use a scale of 1 to 5, with 1 being the best score or no symptoms.
The score will be measured at various time points to identify the recovery trend.
Measured: Up to 1 year
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score
The CTQ (also known as the Levine Questionnaire, Boston Questionnaire, and the Brigham and Women's Questionnaire) contains 19 questions (11 symptom severity questions and 8 functional status questions). All questions use a scale of 1 to 5, with 1 being the best score or no symptoms.
The score will be measured at various time points to identify the recovery trend.
Measured: Up to 1 year
Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer
Measured in kilograms. Grip strength will be measured at various time points to identify the recovery trend.
Measured: Up to 1 year
Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge
Pinch strength will be recorded, to the nearest half-kilogram. It will be measured at various time points to identify the recovery trend.
Measured: Up to 1 year
Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand)
Thresholds on the tip of the finger of both hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacing's are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." The threshold difference will be measured at various time points to identify the recovery trend.
Measured: Up to 1 year
Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand)
A quantitative method to systematically assess the threshold stimulus necessary for perception of light touch to deep pressure by using monofilaments of different sizes.
Interpretation scale for monofilaments:
2.83 Normal 3.61 Diminished light touch 4.31 Diminished protective sensation 4.56 Loss of protective sensation 6.65 Deep pressure sensation only Sensory thresholds will be measured at various time points to identify the recovery trend.
Measured: Up to 1 year
Complication rates for both surgical procedures assessed using a checklist
Complications will be categorized by type, severity, and frequency captured at Surgery, 2-Week, 6-Week, 3-Month, and 12 Month Visits.
Measured: Up to 1 year
Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale
Severity is determined based on responses to three parts sensory, motor, and test outcomes. Each part is scored 1-3, where 3=most disability.
Measured: Enrollment, approximately day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start18 Feb 2020
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy UlnarStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Model description
- This study is a double-blind, multicenter, phase 3, randomized controlled superiority trial examining the treatment effectiveness of in-situ decompression and subcutaneous anterior transposition for UNE.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Curtis National Hand Center, Emory Healthcare, Norton Healthcare, Ohio State University, OrthoCarolina Research Institute, Inc., University of Pittsburgh Medical Center, Wake Forest University Health Sciences, Johns Hopkins University, University of Oklahoma
- Responsible party
- Principal investigator, Dr. Kevin C. Chung, University of Michigan
- Investigators
- Kevin Chung, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254185
- Sponsor's protocol ID
- HUM00133613
- Other IDs
- U01AR073485
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
- ClinicalTrials.gov ID
- NCT04254185
- Acronym / sponsor ID
- HUM00133613
- Conditions
- Neuropathy Ulnar
- Keywords
- Decompression, Anterior Subcutaneous Transposition, Elbow, Ulnar Nerve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Curtis National Hand Center, Emory Healthcare, Norton Healthcare, Ohio State University, OrthoCarolina Research Institute, Inc., University of Pittsburgh Medical Center, Wake Forest University Health Sciences, Johns Hopkins University, University of Oklahoma
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Feb 2020 (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.
This research is studying two surgical procedures in a large group of people to learn about how well these procedures work as a treatment for ulnar neuropathy at the elbow (UNE). Researchers want to see which surgery is more helpful for people with ulnar neuropathy. This research will determine if one surgery is better than the other to alleviate symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a double-blind, multicenter, phase 3, randomized controlled superiority trial examining the treatment effectiveness of in-situ decompression and subcutaneous anterior transposition for UNE.
| Arm | Type | Receives |
|---|---|---|
| Simple decompression | Active comparator | Procedure: Simple decompressionIn-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve. |
| Subcutaneous anterior transposition | Active comparator | Procedure: Subcutaneous anterior transpositionAnterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow
- Confirmation of ulnar neuropathy using the American Association of Electrodiagnostic Medicine criteria for electrodiagnostic studies at the elbow. (Participants must meet at least 1 of the criteria to be enrolled (absolute motor nerve conduction from above elbow (AE) to below elbow (BE) of less than 50 m/s; An AE to BE segment greater than 10 m/s slower than BE to wrist segment; A decrease in compound muscle action potential (CMAP) negative peak amplitude from BE to AE greater than 20%)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Able to read, understand and complete the questionnaires in English
Key exclusion criteria (6 listed)
- Previous elbow fracture requiring surgical fixation
- Patients who have not attempted conservative management for UNE (e.g. night splinting)
- Subluxation of ulnar nerve on preoperative exam
- Recurrent UNE after previous surgery
- Concomitant neuropathic conditions such as Carpal Tunnel Syndrome or cervical or brachial plexus abnormalities
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 |
|---|---|---|
| Simple decompressionAlso: In-situ DecompressionSurgical technique | Procedure or surgery | Simple decompression |
| Subcutaneous anterior transpositionSurgical technique | Procedure or surgery | Subcutaneous anterior transposition |
Primary outcome
Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score
Time frame: 1 year
The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales assessing overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. Scores range from 0-100, 100=no disability). In the pain scale, however, high scores indicate greater pain (0-100, 0=no pain).
9 secondary outcomes
Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score
Time frame: Up to 1 year
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score
Time frame: Up to 1 year
Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score
Time frame: Up to 1 year
Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer
Time frame: Up to 1 year
Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge
Time frame: Up to 1 year
Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand)
Time frame: Up to 1 year
Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand)
Time frame: Up to 1 year
Complication rates for both surgical procedures assessed using a checklist
Time frame: Up to 1 year
Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale
Time frame: Enrollment, approximately day 0
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kevin Chung, MD, MS principal investigator
University of Michigan
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple decompression and Subcutaneous anterior transposition in people with Neuropathy Ulnar, run by University of Michigan at 10 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score (time frame: 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 4 Sep 2026.