N/A N=88 Randomized Triple-blind Treatment

Non-invasive CTS Device Clinical Trial

Carpal Tunnel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03498287 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: BCTQ SSS at 8 Weeks vs Baseline — 2.16; 2.32; -0.62; -0.64 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Study Device (Device); Sham Device (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Pressure Profile Systems, Inc.
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY BCTQ SSS at 8 Weeks vs Baseline	2.16; 2.32; -0.62; -0.64	—
SECONDARY BCTQ SSS	2.24; 2.44; 0.08; 0.12	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03498287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.