Non-invasive CTS Device Clinical Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Study Device; Device: Sham Device

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Mission Pain & Spine
    • Torrance, California, United States, 90710
      • South Bay Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic (Lerner Research Institute)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pressure Profile Systems, Inc.
• Collaborators: The Cleveland Clinic; Kaiser Permanente; Mission Pain and Spine
• Investigators: Study Director: Jae Son, PhD, Pressure Profile Systems

Publications and helpful links

General Publications

• Leite JC, Jerosch-Herold C, Song F. A systematic review of the psychometric properties of the Boston Carpal Tunnel Questionnaire. BMC Musculoskelet Disord. 2006 Oct 20;7:78. doi: 10.1186/1471-2474-7-78.

Helpful Links

• Practice Parameter for Electrodiagnostic Studies in Carpal Tunnel Syndrome: Summary Statement.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): April 21, 2020

Study Registration Dates

• First Submitted: April 8, 2018
• First Submitted That Met QC Criteria: April 8, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; peripheral neuropathy; medical device; carpal tunnel; CTS; musculoskeletal disorder; non-invasive device; wrist pain; repetitive stress injury; non-significant risk
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: PPS-CTS-SBIR2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes