Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome

NCT02534493 | Completed Results

• 1 other identifier: PPS-CTMD-15-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in SSS of the BCTQ at 28 Days vs Baseline

  The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms).

  28 days

Secondary Outcomes (1)

• Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline

  2 months

Study Arms (1)

Carpal Tunnel Medical Device (CTMD)

EXPERIMENTAL

Carpal Tunnel Tissue Manipulation Device (CTMD)

Device: Carpal Tunnel Tissue Manipulation Device (CTMD)

Interventions

Carpal Tunnel Tissue Manipulation Device (CTMD) DEVICE

This piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece for a duration of 2-14 hours.

Also known as: Wrist-Aid

Carpal Tunnel Medical Device (CTMD)

Eligibility Criteria

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

You may qualify if:

• male or female, ages 21-65 and in good general health;
• subject diagnosed with mild to severe carpal tunnel syndrome (CTS) (AANEM criteria for CTS)
• mild CTS: prolonged distal sensory latency with ± decreased sensory amplitude
• moderate CTS: abnormal median sensory latency with prolongation of the distal motor latency
• severe CTS: prolonged motor and sensory distal peak latencies either with a low or absent SNAP or CMAP
• bilateral CTS accepted (either mild, moderate or severe CTS bilaterally), however, more involved wrist (via NCS) used as "study" wrist;
• Boston Carpal Tunnel Questionnaire (BCTQ) Symptoms Score ≥ 2;
• women of childbearing potential must be willing to practice effective contraception for the duration of the study (i.e., abstinence, condoms or diaphragm with spermicide, IUD, or birth control pills \[BCP\]);
• NOTE: Females on birth control pills (BCP) must be stable on the same type and dose of pill for at least three months prior to entering the study and must not change the type of BCP or dosing regimen during the study. Those who have discontinued using BCPs in favor of another form of contraception must have discontinued BCP usage at least 3 months prior to the start of the study.
• women of child bearing potential must have a negative urine pregnancy test at the Baseline Visit (Visit 1, Day 0) and must not be lactating; and
• willingness to follow protocol requirements, including signing an informed consent and health information release forms, attending routine follow-up visits and completing questionnaires.

You may not qualify if:

• known sensitivity to adhesives or glue;
• history of diabetes mellitus;
• history of thyroid disease;
• history of prior wrist fractures;
• known to be easily bruised (hematoma);
• concurrent use of blood thinners;
• history of connective tissue disease;
• diagnosed with superimposed peripheral neuropathy;
• history of cervical radiculopathy;
• diagnosed with purely ulnar paresthesias;
• history of ulnar neuropathy;
• history of brachial plexopathy;
• diagnosed with pronator teres syndrome;
• history of polyneuropathy;
• uncontrolled systemic disease;

Sponsors & Collaborators

• Pressure Profile Systems, Inc.: lead

Study Sites (1)

Mission Pain and Spine

Mission Viejo, California, 92691, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Limitations and Caveats

This study was an open-label pilot study with no placebo. Subjects were not allowed other CTS treatments except for occasional painkillers. Daily home activities not controlled. One subject had wrist arthritis. One subject had unconfirmed arthritis.

Results Point of Contact

• Title: Jae Son
• Organization: Pressure Profile Systems

jaeson@pressureprofile.com

3106418100

Study Officials

• Frank J. King, M.D.

  Mission Pain and Spine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: August 27, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Locations

US (1)