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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
378
Surgical technique
Surgical technique
Emory Healthcare
Atlanta, Georgia, United States
RECRUITINGNorton Healthcare
Louisville, Kentucky, United States
RECRUITINGEffectiveness 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).
Time frame: 1 year
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)
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
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Johns Hopkins University
Baltimore, Maryland, United States
TERMINATEDCurtis National Hand Center
Baltimore, Maryland, United States
RECRUITINGMichigan Medicine
Ann Arbor, Michigan, United States
RECRUITINGOrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
RECRUITINGWake Forest University Health Sciences
Winston-Salem, North Carolina, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGUniversity of Oklahoma
Oklahoma City, Oklahoma, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGDifference 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Enrollment, approximately day 0