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

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ClinicalTrials.gov Identifier: NCT02038205

Recruitment Status : Completed

First Posted : January 16, 2014

Last Update Posted : February 23, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

University of California, Davis

Study Description

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.

Condition or disease
Carpal Tunnel Syndrome

Study Design

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Study Type :	Observational
Actual Enrollment :	213 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	High Resolution Ultrasonographic Measurements of the Median Nerve Before and After Wrist Splinting for Carpal Tunnel Syndrome
Study Start Date :	January 2014
Actual Primary Completion Date :	November 2016
Actual Study Completion Date :	November 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Carpal tunnel syndrome

MedlinePlus related topics: Carpal Tunnel Syndrome

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsies Roussy Levy Syndrome

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Cross sectional area of median nerve using ultrasound [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

Patient-reported outcome measures using NeuroQOL and CTSAQ [ Time Frame: 6 weeks ]
Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study [ Time Frame: 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. [ Time Frame: 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

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

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
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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038205

Locations

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

Sponsors and Collaborators

University of California, Davis

Investigators

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Principal Investigator:	Nanette Joyce, DO	University of California, Davis

More Information

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Responsible Party:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT02038205
Other Study ID Numbers:	336315
First Posted:	January 16, 2014 Key Record Dates
Last Update Posted:	February 23, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:

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Carpal Tunnel Syndrome Syndrome Disease Pathologic Processes Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases	Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries

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