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Non-Invasive CTS Device Clinical Trial

April 5, 2019

Overview

The study device in this trial was created to improve symptoms of carpal tunnel syndrome. The investigators maintain the hypothesis that wearing the study device daily will show improvements in the severity of the pain symptoms reported by the patient.

 

Study Information

This is an interventional, randomized, triple blind (parallel, investigator, outcomes assessor), parallel assignment with an estimated 102 participants. The study involves multiple centers and remote patient centers to wear the non-invasive, unobtrusive study device over the course of eight weeks with the study or sham device, and a four weeks follow up without. There are two arms: an experimental arm in the form of a small, non-invasive, stiff-patch for the wrist and a comparator arm of a sham device that looks similar to the study device but is modified to prevent the main mechanism of action.

 

Inclusion Criteria

  • Those clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)
  • CTS diagnosis by a nerve conduction study performed within the past 12 months or at enrollment
  • Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS) number greater than 2
  • Participants must have reliable access to and ability to use the internet, WIFI, or mobile data
  • They must be willing to abstain from any other CTS treatments or therapies during the study
  • Have the ability to read and write in English, or a reliable person who can read or write in English

 

Exclusion Criteria

  • Individuals with other upper extremity neuropathies (i.e. epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies)
  • Double crush syndrome
  • Cervical stenosis
  • Brachial plexopathy
  • Wrist fractures or cysts
  • Previous wrist surgeries
  • Injection of cortisone into the hand or wrist in the past 6 months
  • Those with:
    • Thyroid disease
    • Rheumatoid arthritis
    • Diabetes
    • Systemic diseases
    • Connective tissue diseases
    • Fibromyalgia or chronic pain syndrome
    • Diabetic neuropathy
    • A body mass index (BMI) greater than 40
  • Have participated in other research studies in the past 2 weeks

 

Location

You may participate in the study at Mission Pain & Spine (recruiting) in Mission Viejo, California, South Bay Medical Center (not yet recruiting) in Torrance, California, and the Cleveland Clinic (recruiting) in Cleveland, Ohio. If you have any questions or concerns, you may contact Bethlehem L Mengesha, MPH, CCRP at Bethlehem.Mengesha@kp.org or Heather Wojanowski at WOJANOH@ccf.org.

 

Sponsors/Collaborators

This study is sponsored by Pressure Profile Systems, Inc. the Cleveland Clinic, Mission Pain & Spine, and Kaiser Permanente. The Study Director is Jae Son, PhD of Pressure Profile Systems, Inc.

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