Non-invasive CTS Device Clinical Trial

• ClinicalTrials.gov Identifier: NCT03498287
• Recruitment Status: Completed
• First Posted: April 13, 2018
• Results First Posted: June 25, 2020
• Last Update Posted: July 14, 2020
• Sponsor: Pressure Profile Systems, Inc.
• Collaborators: The Cleveland Clinic; Mission Pain and Spine; Kaiser Permanente
• Information provided by (Responsible Party): Pressure Profile Systems, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel Syndrome	Device: Study Device; Device: Sham Device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
• Actual Study Start Date: October 10, 2018
• Actual Primary Completion Date: February 28, 2020
• Actual Study Completion Date: April 21, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. BCTQ SSS at 8 Weeks vs Baseline [ Time Frame: baseline and 8 weeks post-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 :

1. BCTQ SSS [ Time Frame: 8-weeks post-Baseline and 12 weeks post-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).

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Mission Pain & Spine

Mission Viejo, California, United States, 92691

South Bay Medical Center

Torrance, California, United States, 90710

United States, Ohio

Cleveland Clinic (Lerner Research Institute)

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Pressure Profile Systems, Inc.

The Cleveland Clinic

Mission Pain and Spine

Kaiser Permanente

Investigators

• Study Director: Jae Son, PhD; Pressure Profile Systems

  Study Documents (Full-Text)

Documents provided by Pressure Profile Systems, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] December 20, 2018

More Information

Additional Information:

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

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. Review.

• Responsible Party: Pressure Profile Systems, Inc.
• ClinicalTrials.gov Identifier: NCT03498287
• Other Study ID Numbers: PPS-CTS-SBIR2
• First Posted: April 13, 2018
• Results First Posted: June 25, 2020
• Last Update Posted: July 14, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Pressure Profile Systems, Inc.:

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

Additional relevant MeSH terms:

Carpal Tunnel Syndrome; Syndrome; Disease; Pathologic Processes; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries