Back to results

Non-invasive CTS Device Clinical Trial

Primary Purpose

Carpal Tunnel Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Study Device

Sham Device

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, carpal tunnel, CTS, musculoskeletal disorder, peripheral neuropathy, repetitive stress injury, non-invasive device, non-significant risk, medical device, wrist pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mission Pain & Spine
South Bay Medical Center
Cleveland Clinic (Lerner Research Institute)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study Device

Sham Device

Arm Description

Small, non-invasive, stiff patch for the wrist

Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

BCTQ SSS

Full Information

NCT ID

NCT03498287

First Posted

April 8, 2018

Last Updated

June 30, 2020

Sponsor

Pressure Profile Systems, Inc.

Collaborators

The Cleveland Clinic, Mission Pain and Spine, Kaiser Permanente

1. Study Identification

Unique Protocol Identification Number

NCT03498287

Brief Title

Non-invasive CTS Device Clinical Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

October 10, 2018 (Actual)

Primary Completion Date

February 28, 2020 (Actual)

Study Completion Date

April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pressure Profile Systems, Inc.

Collaborators

The Cleveland Clinic, Mission Pain and Spine, Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome, carpal tunnel, CTS, musculoskeletal disorder, peripheral neuropathy, repetitive stress injury, non-invasive device, non-significant risk, medical device, wrist pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Device

Arm Type

Experimental

Arm Description

Small, non-invasive, stiff patch for the wrist

Arm Title

Sham Device

Arm Type

Sham Comparator

Arm Description

Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.

Intervention Type

Device

Intervention Name(s)

Study Device

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Sham Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

BCTQ SSS at 8 Weeks vs Baseline

Description

Time Frame

baseline and 8 weeks post-Baseline

Secondary Outcome Measure Information:

Title

BCTQ SSS

Description

Time Frame

8-weeks post-Baseline and 12 weeks post-Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jae Son, PhD

Organizational Affiliation

Pressure Profile Systems

Official's Role

Study Director

Facility Information:

Facility Name

Mission Pain & Spine

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

South Bay Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90710

Country

United States

Facility Name

Cleveland Clinic (Lerner Research Institute)

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17054773

Citation

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.

Results Reference

background

Links:

URL

http://www.aanem.org/Practice/Guidelines-and-Performance-Measures

Description

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

Learn more about this trial

Non-invasive CTS Device Clinical Trial

We'll reach out to this number within 24 hrs