Ultrasonographic Assessment of Carpal Tunnel Syndrome

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT02196220
Collaborator
(none)
44
1
71
0.6

Study Details

Study Description

Brief Summary

Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo syndromes. These patients have a genetic enzyme deficiency that results in the inability to degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell enlargement and subsequent dysfunction. The accumulation occurs in all tissues including cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits, and various other orthopaedic manifestations [Van Heest, White]. These children often suffer from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal tunnel syndrome is almost always present, but may not become apparent until symptoms are severe and loss of function has occurred. The current gold standard for diagnosis consists of electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general anesthetic [Khanna].

Primary Objective: The investigators plan to correlate EMG findings and median nerve cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the need for EMG studies and anesthesia.

Secondary Objective: The investigators want to determine the cross-sectional area of the median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The investigators plan to evaluate a cohort of healthy children to determine a normal cross-sectional area of the median nerve.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    44 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ultrasonographic Assessment of Carpal Tunnel Syndrome in Children With Mucopolysaccharidosis and Comparison to Median Nerve Anatomy in Healthy Children.
    Study Start Date :
    Jul 1, 2013
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Jun 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Median nerve cross-sectional area in children with mucopolysaccharidosis and a cohort of healthy children, ages 3-12. [6-weeks after open carpal tunnel release]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    For the first arm of the study (25 participants):
    • Children with mucopolysaccharidosis presenting to the senior author's clinic with signs or symptoms of carpal tunnel syndrome will be enrolled to receive both an EMG and carpal tunnel ultrasound of the upper extremities.
    For the second arm of the study (100 participants):
    • Healthy children ages 3-12 with no acute upper extremity trauma or history of mucopolysaccharidosis.

    • 25 additional participants requested in case of inconclusive ultrasound results, patient removal, or other unusable results.

    Exclusion Criteria:
    First arm:
    • Children with mucopolysaccharidosis who have undergone previous treatment for carpal tunnel syndrome.
    Second arm:
    • Acute (<3month) wrist or hand surgery/injuries.

    • Unable to obtain parental consent or patient assent.

    • History of mucopolysaccharidosis.

    • Non-english speaking.

    • Cognitive impairment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah/Primary Children's Medical Center Salt Lake City Utah United States 84121

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Douglas T Hutchinson, M.D., University of Utah Orthopedic Center
    • Principal Investigator: Amy Moeller, M.D., University of Utah Orthopedic Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Hutchinson, M.D., University of Utah
    ClinicalTrials.gov Identifier:
    NCT02196220
    Other Study ID Numbers:
    • 59910
    First Posted:
    Jul 21, 2014
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2019