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Completed

NCT Number: NCT02038205

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cross sectional area of median nerve using ultrasound

    Time frame: 6 weeks

Secondary outcomes

  1. Patient-reported outcome measures using NeuroQOL and CTSAQ

    Time frame: 6 weeks

  2. Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study

    Time frame: 6 weeks

  3. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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