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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038205
First Posted: January 16, 2014
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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
Carpal Tunnel Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

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 ]

Enrollment: 213
Study Start Date: January 2014
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Nanette Joyce, DO University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02038205     History of Changes
Other Study ID Numbers: 336315
First Submitted: January 7, 2014
First Posted: January 16, 2014
Last Update Posted: February 23, 2017
Last Verified: February 2017

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