Non-invasive CTS Device Clinical Trial

Pressure Profile Systems, Inc.88 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Carpal Tunnel Syndrome

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS) 2. 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) 3. BCTQ SSS \> 2 4. Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets 5. Willing to abstain from any other treatment or therapies for CTS throughout the study 6. Ability to read and write English, or has a reliable person to assist with reading and writing English Exclusion Criteria: 1. Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies) 2. Double crush syndrome 3. Cervical stenosis 4. Brachial plexopathy 5. Wrist fractures or cysts 6. Prior wrist surgeries, especially carpal tunnel release surgery 7. Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months 8. Thyroid disease 9. Rheumatoid arthritis 10. Diabetes 11. Systemic diseases 12. Connective tissue diseases 13. Fibromyalgia or chronic pain syndrome 14. Diabetic neuropathy 15. BMI \> 40 16. Participation in other research studies or clinical trials currently or within the past 2 weeks. To assess eligibility, visit: carpaltunneltrial.com

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

Outcomes

Primary Outcomes

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).

Time frame: baseline and 8 weeks post-Baseline

Secondary Outcomes

BCTQ SSS

Time frame: 8-weeks post-Baseline and 12 weeks post-Baseline

Data from ClinicalTrials.gov

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