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Non-invasive CTS Device Clinical Trial

NCT03498287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-07-14

Study results available
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Summary

Sham-controlled, multi-center and remote patient-centered randomized controlled clinical trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.

Conditions

  • Carpal Tunnel Syndrome

Interventions

DEVICE

Study Device

Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks).

DEVICE

Sham Device

Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). \*Note: participants in the sham group are given the real study device at the end of the Post-Treatment/Follow-up Phase.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Mission Pain and Spine

    collaborator OTHER

  • Kaiser Permanente

    collaborator OTHER

  • Pressure Profile Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Jae Son, PhD · Pressure Profile Systems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2020-02-28
Completion
2020-04-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03498287 on ClinicalTrials.gov