High Resolution Ultrasonographic Measurements of the Median Nerve Before and After Wrist Splinting for Carpal Tunnel Syndrome

University of California, Davis1 site in 1 country213 target enrollmentJanuary 2014

ConditionsCarpal Tunnel Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carpal Tunnel Syndrome
Sponsor: University of California, Davis
Enrollment: 213
Locations: 1
Primary Endpoint: Cross sectional area of median nerve using ultrasound
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective cohort follow-up study design is undertaken. Both males and females with mild to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and undergo follow up studies for data collection. Controls will also be seen for a one time visit.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

November 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of California, Davis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years or older and;
•Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index \> 0.9 where first line therapy is indicated to include nocturnal wrist bracing
•Control subjects without symptoms of carpal tunnel syndrome.

Exclusion Criteria

•Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
•Untreated hypothyroidism, Rheumatologic disorders
•Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
•Undergoing or previously treated for carpal tunnel on affected side. This includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention.
•Currently pregnant or \< 3 months post partum
•History of wrist, hand fracture or severe trauma to affected hand and/or wrist
•Known tumor, mass or deformity of the hand/wrist
•Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
•History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation
•Diagnosed neuromuscular disorders which may complicate CTS diagnosis

Outcomes

Primary Outcomes

Cross sectional area of median nerve using ultrasound

Time Frame: 6 weeks

Secondary Outcomes

Patient-reported outcome measures using NeuroQOL and CTSAQ(6 weeks)
Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study(6 weeks)
cross sectional area, electrodiagnostic study, age, gender, height, weight, BMI, wrist circumference, wrist width. smoking and handedness as predictors of improvement (or no improvement) in the NeuroQOL and CTSAQ-measured clinical severity scale.(6 weeks)