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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02038205
Enrollment
213
Registered
2014-01-16
Start date
2014-01-31
Completion date
2016-11-30
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

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.

Interventions

None listed

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Cross sectional area of median nerve using ultrasound6 weeks

Secondary

MeasureTime frame
Patient-reported outcome measures using NeuroQOL and CTSAQ6 weeks
Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study6 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026