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

October 3, 2023 updated by: MiniStim LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • Seva Medical
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Time Frame: 3-Months
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
Time Frame: 3-months
Device- and procedure-related Adverse Events (AE) rate at 3-months.
3-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Function: Ability to do one-legged knee bends
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
Medication usage before and after treatment in active and delayed group subjects.
3, 6, 9, 12, 24, 36-months
Change in Range of Motion
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in American Knee Society Score
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 3, 6, 9, 12, 24, 36-months
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
Time Frame: 6, 9, 12, 24, 36 months
Device- and procedure-related Adverse Events (AE) rate throughout the study
6, 9, 12, 24, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MiniStim LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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