Clinical trial NCT02038205: Ultrasonographic Measurements of the Median Nerve Before and After Splinting for Carpal Tunnel Syndrome
Official title: High Resolution Ultrasonographic Measurements of the Median Nerve Before and After Wrist Splinting for Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Those with diagnosis of carpal tunnel syndrome, and healthy control subjects with no symptoms of CTS.

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.


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

Primary outcomes:
measure: Cross sectional area of median nerve using ultrasound
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient-reported outcome measures using NeuroQOL and CTSAQ
timeFrame: 6 weeks
measure: Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Nanette Joyce, DO
role: PRINCIPAL_INVESTIGATOR
References: