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

Prospective, Multi-center, Randomized Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Knee Pain
• Intervention / Treatment: Device: MiniStim PNS

Detailed Description

This is a prospective, randomized, controlled, multi-center study in which up to 300 evaluable subjects will receive MiniStim PNS. Target subjects will have chronic knee pain.

Subjects will be randomized into either the active or delayed group. Devices will be activated post-op in accordance to the randomization assignment. 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. Implanted subjects will be educated on the use of the transmitter. Programming changes can be done as needed during this time period to maximize clinical response according to pre-programmed settings. Subjects randomized to the Delayed group will begin 2-hour stimulation/day at the 3-Month visit.

The primary endpoint will be at 3-Months, comparing Active vs. Delayed data from baseline data, and subjects in the Delay group will begin stimulation. At the 3-month visit, VAS will be completed and compared to baseline VAS, during this visit the safety and efficacy of the device will be assessed, and subjects in the Delayed group will be instructed to begin daily stimulation for a minimum of 2 hours a day. Subjects will be seen at 3-month intervals through the 12-Month visit for data collection and adverse event review. Subjects will continue therapy and followed for a total of 36-months with primary outcomes assessed at 3-months. Their participation in the study will end at 36-months.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shanice Saunders; Phone Number: 888-691-0585; Email: contact@micronmed.com
• Study Contact Backup: Name: Marlene Pena; Phone Number: 888-691-0585; Email: contact@micronmed.com

Study Locations

• United States
  • Texas
    • Lewisville, Texas, United States, 75057
      • Recruiting
      • Seva Medical
      • Contact: Bambi Fritz; Phone Number: 214-306-4116; Email: bfritz@oshun.run

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 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; MiniStim PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.
Placebo Comparator: Delayed; The delayed group will begin 2-hour stimulation/day at the 3-Month visit.	Device: MiniStim PNS; MiniStim PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function: Ability to do one-legged knee bends	The ability to do one-legged knee bends (percentage increase in knee bends).	3, 6, 9, 12, 24, 36-months
Subset Symptoms: Mental Component Score	Change in Mental Component Score measured by SF-36 questionnaire measured on a scale of 1-5; 1 (all of the time) to 5 (none of the time).	3, 6, 9, 12, 24, 36-months
Medication Usage	Medication usage before and after treatment in active and delayed group subjects.	3, 6, 9, 12, 24, 36-months
Change in Range of Motion	Change in knee range of motion as measured with Knee Range of Motion questionnaire.	3, 6, 9, 12, 24, 36-months
Subset Symptoms: Physical Component Score	Change in Physical Component Score measured by SF-36 questionnaire measured on a scale of 1-5; 1 (all of the time) to 5 (none of the time).	3, 6, 9, 12, 24, 36-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in American Knee Society Score	Change in American Society Score before and after treatment between the treated knee and the untreated knee in active and delayed group subjects with bilateral knee pain from osteoarthritis, trauma, or surgery. The score interval is measured 0 (none) to 10 (severe).	3, 6, 9, 12, 24, 36-months
Change in Short-Form McGill Pain Questionnaire	Change in McGill Pain Questionnaire before and after treatment between the treated knee and the untreated knee in active and delayed group subjects with bilateral knee pain from osteoarthritis, trauma, or surgery. This questionnaire is measured on a scale of 0 (none) to 10 (worst possible).	3, 6, 9, 12, 24, 36-months
Change in Western Ontario and McMaster University Arthritis Index	Change in Western Ontario and McMaster University Arthritis Index before and after treatment between the treated knee and the untreated knee in active and delayed group subjects with bilateral knee pain from osteoarthritis, trauma, or surgery. The Western Ontario and McMaster University Arthritis Index scale is measured on a scale of 1 (none) to 5 (extreme).	3, 6, 9, 12, 24, 36-months
Change in Global Perceived Effect Scales	Change in Global Perceived Effect Scales (GPES) before and after treatment between the treated knee and the untreated knee in active and delayed group subjects with bilateral knee pain from osteoarthritis, trauma, or surgery. The Global Perceived Effect Scales range is measured from 1 (much worse) to 7 (much better).	3, 6, 9, 12, 24, 36-months
Change in Quality of Life	Change in Quality of Life (QoL) captured utilizing on the EQ-5D-5L survey, the form captures quality of life activities such as Mobility, Self-Care, Usual Activities, Pain/Discomfort, and rating their health for the day from 0 to 100. The EQ-5D-5L survey is measured from having no problems, slight problems, moderate problems, severe problems, or unable to perform quality of life activities.	3, 6, 9, 12, 24, 36-months
Change in Douleur Neuropathique 4 Questionnaire	Change in Douleur Neuropathique 4 questionnaire to estimate the degree of neuropathic pain before and after treatment in active and delayed group subjects, minimum score of 1 and maximum score of 10.	3, 6, 9, 12, 24, 36-months
Work Status	Work history and status will be evaluated based on a subject's self-reported questionnaire(s) completed at screening/baseline and all follow up visits.	3, 6, 9, 12, 24, 36-months
Operating time, skin to skin and irradiation time	Operating time, skin-to-skin time, and irradiation time for implant surgery will be collected and tallied in each treatment group.	3, 6, 9, 12, 24, 36-months
Pain Location maps	Pain location maps will be developed for each subject at baseline and follow-up to document and evaluate area of pain throughout the study.	3, 6, 9, 12, 24, 36-months
Safety Assessment: Adverse Events	Device- and procedure-related Adverse Events (AE) rate throughout the study	6, 9, 12, 24, 36 months

Collaborators and Investigators

• Sponsor: MiniStim LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FLEX 31-00104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes