Non-invasive CTS Device Clinical Trial

Status Completed

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

Clinical Trial Details

NCT number	NCT03498287
Study type	Interventional
Source	Pressure Profile Systems, Inc.
Contact
Status	Completed
Phase	N/A
Start date	October 10, 2018
Completion date	April 21, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05067205` - Minimal Invasive Carpal Tunnel Release With the Novel Device	N/A
Completed	`NCT03184688` - Platelet Rich Plasma for Carpal Tunnel Syndrome	N/A
Completed	`NCT03582735` - Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome	N/A
Completed	`NCT05490420` - Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome	N/A
Recruiting	`NCT05970692` - Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Completed	`NCT04043780` - Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome	N/A
Completed	`NCT03880812` - Cost Information on Carpal Tunnel Syndrome Treatment Decisions	N/A
Completed	`NCT06464809` - Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS)	N/A
Recruiting	`NCT05503719` - An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial	N/A
Recruiting	`NCT05372393` - Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block	N/A
Recruiting	`NCT05328180` - aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)	N/A
Recruiting	`NCT05466162` - Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome	N/A
Completed	`NCT04060875` - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Not yet recruiting	`NCT06294821` - 4AP to Delay Carpal Tunnel Release (CTR)	Phase 2/Phase 3
Not yet recruiting	`NCT04328805` - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.	Phase 4
Terminated	`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