Ultrasonographic Assessment of Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196220
• Other study ID #: 59910
• Status: Completed
• Start date: July 2013
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	University of Utah/Primary Children's Medical Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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