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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038205
• Other study ID #: 336315
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: February 22, 2017
• Start date: January 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional area of median nerve using ultrasound		6 weeks
Secondary	Patient-reported outcome measures using NeuroQOL and CTSAQ		6 weeks
Secondary	Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study		6 weeks
Secondary	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