Ultrasonographic Assessment of Carpal Tunnel Syndrome

Ultrasonographic Assessment of Carpal Tunnel Syndrome in Children With Mucopolysaccharidosis and Comparison to Median Nerve Anatomy in Healthy Children.

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • University of Utah/Primary Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 59910