CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Study Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03498287
NCT03498287N/ACompleted
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Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome

Pressure Profile Systems, Inc.·interventional·Posted Apr 13, 2018·Updated Jul 14, 2020

In Brief

A clinical study evaluating Study Device and Sham Device for Carpal Tunnel Syndrome. Completed, enrolled 88 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarpal Tunnel Syndrome
CountriesUnited States
CollaboratorsThe Cleveland Clinic, Mission Pain and Spine, Kaiser Permanente

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 13, 2018
Enrollment StartOct 10, 2018
Primary CompletionFeb 28, 2020
Study CompletionApr 21, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.2 years ago

Interventions

Study Devicedevice

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).

Sham Devicedevice

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.