Non-invasive CTS Device Clinical Trial

NCT03498287 | Completed Results FDA Device

• 1 other identifier: PPS-CTS-SBIR2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• BCTQ SSS

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

Study Arms (2)

Study Device

EXPERIMENTAL

Small, non-invasive, stiff patch for the wrist

Device: Study Device

Sham Device

SHAM COMPARATOR

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

Device: Sham Device

Interventions

Study Device 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).

Study Device

Sham Device 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.

Sham Device

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pressure Profile Systems, Inc.: lead
• The Cleveland Clinic: collaborator
• Mission Pain and Spine: collaborator
• Kaiser Permanente: collaborator

Study Sites (3)

Mission Pain & Spine

Mission Viejo, California, 92691, United States

Location

South Bay Medical Center

Torrance, California, 90710, United States

Location

Cleveland Clinic (Lerner Research Institute)

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 17054773 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Sprains and Strains; Wounds and Injuries

Limitations and Caveats

Sham device was not thoroughly tested before the trial. Post-trial testing suggest some mechanical effect that could have influenced the sham group response. Early termination of enrollment reduced the power of the statistical analysis.

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Pressure Profile Systems

research@wrist-aid.com

310.641.8100

Study Officials

• Jae Son, PhD

  Pressure Profile Systems

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 13, 2018
• Study Start: October 10, 2018
• Primary Completion: February 28, 2020
• Study Completion: April 21, 2020
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)