Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasonographic Assessment of Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02196220
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah

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
Carpal Tunnel Syndrome

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 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 : July 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021





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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study Size: *150 total which includes the following:

Arm 1: 25 Children with mucopolysaccharidosis

Arm 2: 100 Control Group - Healthy children ages 3-12 with no previous history of upper extremity trauma or history of mucopolysaccharidosis.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196220


Locations
Layout table for location information
United States, Utah
University of Utah/Primary Children's Medical Center
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Douglas T Hutchinson, M.D. University of Utah Orthopedic Center
Principal Investigator: Amy Moeller, M.D. University of Utah Orthopedic Center

Layout table for additonal information
Responsible Party: Douglas Hutchinson, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT02196220     History of Changes
Other Study ID Numbers: 59910
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries