Clinical Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

NCT04580732 | Unknown FDA Device

• 1 other identifier: FLEX 31-00104
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a \>50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and 36-months.

Conditions

Chronic Knee Pain

Outcome Measures

Primary Outcomes (2)

• Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale

  Improvement pain defined as a \>50% pain relief as measured by VAS without increase in baseline medications. To demonstrate clinically significant improvements in the pain of subjects in the active group compared to the subjects in the delayed group.

  3-Months

• Adverse Events

  Device- and procedure-related Adverse Events (AE) rate at 3-months.

  3-months

Secondary Outcomes (5)

• Physical Function: Ability to do one-legged knee bends

  3, 6, 9, 12, 24, 36-months

• Subset Symptoms: Mental Component Score

  3, 6, 9, 12, 24, 36-months

• Medication Usage

  3, 6, 9, 12, 24, 36-months

• Change in Range of Motion

  3, 6, 9, 12, 24, 36-months

• Subset Symptoms: Physical Component Score

  3, 6, 9, 12, 24, 36-months

Other Outcomes (10)

• Change in American Knee Society Score

  3, 6, 9, 12, 24, 36-months

• Change in Short-Form McGill Pain Questionnaire

  3, 6, 9, 12, 24, 36-months

• Change in Western Ontario and McMaster University Arthritis Index

  3, 6, 9, 12, 24, 36-months

Study Arms (2)

Active

ACTIVE COMPARATOR

Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study.

Device: MiniStim PNS

Delayed

PLACEBO COMPARATOR

The delayed group will begin 2-hour stimulation/day at the 3-Month visit.

Device: MiniStim PNS

Interventions

MiniStim PNS DEVICE

MiniStim PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.

Active; Delayed

Eligibility Criteria

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

You may qualify if:

• A. Capable of giving informed consent and willing to follow all study related procedures;
• B. Women and men \>18 years of age;
• C. Baseline VAS score of \> 5;
• D. History of chronic, function-limiting knee pain of at least three months;
• E. Not had recent surgical procedures of the knee within the last three months;
• F. ≥50% temporary relief from temporary nerve diagnostics;
• G. No evidence of anatomic abnormalities that could jeopardize the placement of the device;
• H. Able to operate programmer, recharger, study assessments and provide accurate responses;
• I. Appropriate candidate for the implant procedure based on the opinion of investigator.

You may not qualify if:

• A. An active implantable electronic device regardless of whether stimulation is ON or OFF;
• B. Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
• C. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during study;
• D. Subject noted no relief from temporary nerve diagnostics;
• E. Inability to achieve appropriate positioning;
• F. Inability to understand informed consent and protocol;
• G. Conditions requiring recurring MRI evaluation or diathermy procedures;
• H. Anatomical restrictions such that device placement is not possible;
• I. Have a life expectancy of less than 1-year;
• J. Worker's compensation claimants;
• K. Based on opinion of investigator any legal concerns that would preclude his/her enrollment in the study or potentially confound results;
• L. Deemed unsuitable for enrollment by investigator based on medical history or physical examination.

Sponsors & Collaborators

• MiniStim LLC: lead

Study Sites (1)

Seva Medical

Lewisville, Texas, 75057, United States

RECRUITING

Central Study Contacts

Shanice Saunders

CONTACT

888-691-0585; contact@micronmed.com

Marlene Pena

CONTACT

888-691-0585; contact@micronmed.com

Study Design

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

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: May 5, 2021
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (1)