A Study of Clinical Outcomes of Ultrasound-guided Carpal Tunnel Release Performed in a Procedural Room Setting

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Albert Lea, Minnesota: 18-010140
    Sponsor Protocol Number: 18-010140

About this study

The purpose of this study is to document the primary investigator’s clinical experience performing Ultrasound Guided Carpal Tunnel Release (USCTR) in the clinic procedure room setting through retrospective and prospective analysis of these now routinely collected clinical outcomes. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Male and female patients ages > 18 years or older.
  • Male and female patients with a clinical diagnosis of CTS and a CTS-6 score of > 12.43.
  • Confirmatory electrodiagnostic testing indicating median neuropathy at the wrist (i.e., consistent with a clinical diagnosis of CTS) or ultrasound findings consistent with median nerve enlargement in the carpal tunnel.43-48.
  • Candidate for surgical CTR based on severe and/or refractory symptoms.
  • Following discussion of surgical options for CTR, the patient elects to proceed with USCTR.

Exclusion Criteria:

  • Inability to complete the informed consent process or outcome questionnaires.
  • Previous carpal tunnel release or wrist surgery on the ipsilateral side.
  • Previous history of complex regional pain syndrome (CRPS).
  • Previous history of upper limb vascular disease (including documented thoracic outlet syndrome) or Raynaud’s phenomenon.
  • Traumatic injury to the median nerve or any of its branches on the ipsilateral side.
  • Contraindication to proceeding with USCTR based on diagnostic ultrasound.
  • Patients who are anticoagulated with an INR >3.0.
  • Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated procedure.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Albert Lea, Minn.

Mayo Clinic principal investigator

Mark Ciota, M.D.

Contact us for the latest status

Contact information:

Russell Bergum D.O.

(507)373-2384

Bergum.Russell@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20455988

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