Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

It is hypothesized that daily wear of the study device will result in significant improvements in patient-reported symptom severity. It is also hypothesized that the effects from active study device treatment will be significantly greater than effects from sham treatment. In both cases, it is hypothesized that improvements will be sustained post-treatment.

This study is designed as a randomized, double-blind, sham-controlled, two-arm trial consisting of an eight-week treatment period (active study device or sham), followed by one required follow-up four weeks later (at week 12).

There are two study groups: the active device group receiving the active study device and the sham group receiving a non-active sham device. Subjects will be informed that they have a 50:50 chance of receiving treatment or a sham. They will also be informed that if they receive sham device, they will be offered the active device 4 weeks into the post-treatment period. However, all subjects will not know what treatment they are on until the conclusion of the trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03498287
Study type Interventional
Source Pressure Profile Systems, Inc.
Contact Pauline Luong, ME
Phone 425-298-3775
Email info@carpaltunneltrial.com
Status Recruiting
Phase N/A
Start date October 2018
Completion date June 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03184688 - Platelet Rich Plasma for Carpal Tunnel Syndrome N/A
Active, not recruiting NCT03582735 - Preoperative Nerve-gliding Exercises for Individuals With Carpal Tunnel Syndrome N/A
Not yet recruiting NCT02791529 - Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release Phase 1
Completed NCT02141035 - Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome Phase 2/Phase 3
Completed NCT01887145 - Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome N/A
Recruiting NCT01897272 - Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study N/A
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A
Enrolling by invitation NCT01017471 - Carpal Tunnel Syndrome Release Using PSU Retractor Phase 3
Completed NCT00991068 - Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome Phase 2
Completed NCT00981565 - Mild Carpal Tunnel Syndrome N/A
Active, not recruiting NCT00521495 - Carpal Tunnel Syndrome and Static Magnetic Field Therapy Phase 2
Completed NCT00634699 - The Treatment of Carpal Tunnel Syndrome Using Thumb Pressure Along the Median Nerve Phase 1/Phase 2
Recruiting NCT03729375 - The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release Phase 1
Recruiting NCT02907671 - Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome N/A
Recruiting NCT03036657 - Local Effects of Acupuncture and Nerve Conduction Studies N/A
Completed NCT03169218 - Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom N/A
Completed NCT02553811 - Diagnosis of Carpal Tunnel Syndrome: Effectiveness of Diagnostic Tests. Clinical Trial of Accuracy N/A
Recruiting NCT02315573 - Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery N/A
Completed NCT02070302 - BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome Phase 2
Completed NCT02276105 - Investigation of Psychometric Properties of the EuroQoL EQ-5D-5L in Patients With Carpal Tunnel Syndrome N/A