N/A
Completed N=88
Non-invasive CTS Device Clinical Trial
Source: ClinicalTrials.gov NCT03498287 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: BCTQ SSS at 8 Weeks vs Baseline — 2.16; 2.32; -0.62; -0.64 score on a scale
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.
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 | — |
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
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. Informational only — not medical advice.