Non-invasive CTS Device Clinical Trial

Not Applicable

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

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
1. CTS severity determined via AANEM criteria 13
2. 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

Primary Outcome Measures

Name	Time	Method
BCTQ SSS at 8 Weeks vs Baseline	baseline and 8 weeks post-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).

Secondary Outcome Measures

Name	Time	Method
BCTQ SSS	8-weeks post-Baseline and 12 weeks post-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).

Locations (3): Mission Pain & Spine
🇺🇸
Mission Viejo, California, United States
South Bay Medical Center
🇺🇸
Torrance, California, United States
Cleveland Clinic (Lerner Research Institute)
🇺🇸
Cleveland, Ohio, United States
Mission Pain & Spine
🇺🇸Mission Viejo, California, United States