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

NCT ID: NCT02038205

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 213 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-11-30

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nanette Joyce, DO

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

336315

Identifier Type: -

Identifier Source: org_study_id