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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT02038205
First received: January 7, 2014
Last updated: January 14, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-reported outcome measures using NeuroQOL and CTSAQ [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: January 2014
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038205

Contacts
Contact: Colleen Anthonisen 916-734-4307 colleen.anthonisen@ucdmc.ucdavis.edu

Locations
United States, California
UC Davis Medical Center Not yet recruiting
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Jay Han, MD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02038205     History of Changes
Other Study ID Numbers: 336315
Study First Received: January 7, 2014
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014