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

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Those with diagnosis of carpal tunnel syndrome, and healthy control subjects with no symptoms of CTS.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cross sectional area of median nerve using ultrasound	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Nanette Joyce, DO, University of California, Davis

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

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: 336315