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NCT Number: NCT04254185

Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

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.

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Key information

Conditions

Neuropathy Ulnar Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Ulnar Neuropathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Healthcare, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Simple decompression

Procedure

Surgical technique

Other names: In-situ Decompression

Subcutaneous anterior transposition

Procedure

Surgical technique

Primary outcomes

  1. 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).

Secondary outcomes

  1. Recovery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) pain score

    Time frame: Up to 1 year

    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)

  2. Recovery as assessed by the Carpal tunnel questionnaire (CTQ) symptom score

    Time frame: Up to 1 year

    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.

  3. Recovery as assessed by the Carpal tunnel questionnaire (CTQ) pain score

    Time frame: Up to 1 year

    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.

  4. Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer

    Time frame: Up to 1 year

    Measured in kilograms. Grip strength will be measured at various time points to identify the recovery trend.

  5. Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge

    Time frame: Up to 1 year

    Pinch strength will be recorded, to the nearest half-kilogram. It will be measured at various time points to identify the recovery trend.

  6. Difference in distance assessed by the 2 Point Discrimination (unaffected hand - affected hand)

    Time frame: Up to 1 year

    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.

  7. Sensory difference as assessed by Semmes-Weinstein Monofilament test (unaffected hand - affected hand)

    Time frame: Up to 1 year

    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.

  8. Complication rates for both surgical procedures assessed using a checklist

    Time frame: Up to 1 year

    Complications will be categorized by type, severity, and frequency captured at Surgery, 2-Week, 6-Week, 3-Month, and 12 Month Visits.

  9. Disease severity as measured by ulnar neuropathy at the elbow (UNE) severity scale

    Time frame: Enrollment, approximately day 0

    Severity is determined based on responses to three parts sensory, motor, and test outcomes. Each part is scored 1-3, where 3=most disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Sunitha Malay

CONTACT

[email protected]

734-763-1834

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Curtis National Hand Center
  • Emory Healthcare
  • Johns Hopkins University
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Norton Healthcare
  • Ohio State University
  • OrthoCarolina Research Institute, Inc.
  • University of Oklahoma
  • University of Pittsburgh Medical Center
  • Wake Forest University Health Sciences

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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