Non-invasive CTS Device Clinical Trial

NCT ID: NCT03498287

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2020-04-21

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Study Device

Small, non-invasive, stiff patch for the wrist

Group Type: EXPERIMENTAL

Study Device

Intervention Type: 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 Device

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

Group Type: SHAM_COMPARATOR

Sham Device

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Mission Pain and Spine

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Pressure Profile Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Son, PhD

Role: STUDY_DIRECTOR

Pressure Profile Systems

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17054773 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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

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

Other Identifiers

PPS-CTS-SBIR2

Identifier Type: -

Identifier Source: org_study_id