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Enrolling by Invitation

NCT Number: NCT04804293

Assessment of Carpal Tunnel Syndrome by Shearwave Elastography

This study is being done to test a new ultrasound method to detect possible stiffness problems within wrist(s). The purpose of this research is to the test the effectiveness of a new ultrasound method to check the nerve and surrounding tissue in both wrist of patient volunteers before and after treatment.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Demyelinating Diseases 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–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

The ultrasound system is FDA approved. The risks associated with this research study are not beyond the normal risk of conventional ultrasound and should not cause you any discomfort. Ultrasound at the intensity levels and duration used in this study has not been shown to present risk to humans. The investigators will conduct the SWE study on the set time point when the patient returns for follow-up after the therapy (surgical decompression or corticosteroid injection).

A set of pictures will be taken of patients wrists by the FDA approved ultrasound system. This system uses a special type of ultrasound for imaging your wrists.

The ultrasound study will be repeated after 3 and 6 months after the treatments.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female volunteers.
  • Age ≥ 18 years old.
  • Having unilateral symptom of wrist pain
  • Scheduled for corticosteroid injection or surgery

Exclusion criteria

  • Individuals less than 18 years of age.
  • Prior surgery.
  • People considered in "vulnerable" populations.
  • Having bilateral symptoms

Treatment and study plan

FDA approved ultrasound system with shear wave elastography capability

Device

The investigators will acquire at least 4 acquisitions for each of 2 locations on the wrist. The objective is to correlate SWE measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX). Evaluate the treatment response to surgical decompression or corticosteroid injection, using quantitative SWE and correlate the results to repeated patient reported outcomes with Boston CTQ, and objective clinical improvement with Semmes-Weinstein monofilament evaluation for recovery of sensibility, and grip and lateral pinch strength.

Primary outcomes

  1. Evaluate the treatment response by shear wave elastography (SWE)

    Time frame: First 3 months

    Evaluate the treatment response to surgical decompression or corticosteroid injection, using quantitative SWE and correlate the results to repeated patient reported outcomes with Boston CTQ, and objective clinical improvement with Semmes-Weinstein monofilament evaluation for recovery of sensibility, and grip and lateral pinch strength.

Secondary outcomes

  1. Correlate shear wave elastography (SWE) measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX) elasticity

    Time frame: 3 to 6 months

    Determine the severity and patient outcome scores in patients with symptoms of CTS and Correlate the symptom severity and functional status assessed by the Boston Carpal tunnel Questionnaire (CTQ)21 validated patient outcome scoring profile) in patients with diagnosis of carpal tunnel syndrome with SWE determined median nerve (MN) stiffness.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Treatment Monitoring of Carpal Tunnel Syndrome Using Shear Wave Elastography: A Pilot in Vivo Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2021
Registry last updated
Jan 21, 2026

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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