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

NCT02038205 | Completed

• 1 other identifier: 336315
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cross sectional area of median nerve using ultrasound

  6 weeks

Secondary Outcomes (3)

• Patient-reported outcome measures using NeuroQOL and CTSAQ

  6 weeks

• Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study

  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.

  6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Nanette Joyce, DO

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)