Non-invasive CTS Device Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: Study Device
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS) CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit CTS severity determined via AANEM criteria 13 Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the study wrist) BCTQ SSS > 2 Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets Willing to abstain from any other treatment or therapies for CTS throughout the study Ability to read and write English, or has a reliable person to assist with reading and writing English Exclusion Criteria: Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies) Double crush syndrome Cervical stenosis Brachial plexopathy Wrist fractures or cysts Prior wrist surgeries, especially carpal tunnel release surgery Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months Thyroid disease Rheumatoid arthritis Diabetes Systemic diseases Connective tissue diseases Fibromyalgia or chronic pain syndrome Diabetic neuropathy BMI > 40 Participation in other research studies or clinical trials currently or within the past 2 weeks. To assess eligibility, visit: carpaltunneltrial.com

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Device<br>Small, non-invasive, stiff patch for the wrist | Device: Study Device<br>* 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).<br>|
| Sham Comparator: Sham Device<br>Device that looks like the Study Device but modified to prevent or remove the main mechanism of action. | Device: Sham Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCTQ SSS at 8 Weeks vs Baseline | The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms). | baseline and 8 weeks post-Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCTQ SSS | The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms). | 8-weeks post-Baseline and 12 weeks post-Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrist pain, carpal tunnel syndrome, carpal tunnel, CTS, musculoskeletal disorder, peripheral neuropathy, repetitive stress injury, non-invasive device, non-significant risk, medical device