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

Completed

• Conditions: Carpal Tunnel Syndrome

• Registration Number: NCT02038205
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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
• Implanted electronic device (pacemaker, intrathecal pump/stimulator)
• Any illness that makes it unsafe for the patient to participate in the study
• Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cross sectional area of median nerve using ultrasound	6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States