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Neurostimulation Device
MiniStim PNS for Chronic Knee Pain
N/A
Recruiting
Research Sponsored by MiniStim LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of chronic, function-limiting knee pain of at least three months
D. History of chronic, function-limiting knee pain of at least three months;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, 12, 24, 36-months
Awards & highlights
Study Summary
This trial will compare the effectiveness of two different treatments for chronic pain relief.
Who is the study for?
This trial is for adults over 18 with chronic knee pain lasting at least three months, a VAS score above 5, and who've had temporary relief from nerve diagnostics. Candidates must be able to give consent, follow procedures, operate the device, and not have had recent knee surgery or anatomical issues affecting device placement.Check my eligibility
What is being tested?
The 'FLEX' study tests the MiniStim PNS on individuals with chronic knee pain. Participants are randomly assigned to receive active therapy immediately or after a three-month delay. Pain relief without increased medication is measured at several intervals up to 36 months.See study design
What are the potential side effects?
While specific side effects of MiniStim PNS aren't detailed here, similar devices may cause discomfort at the implant site, infection risk, potential interference with other electronic devices in the body, and possible technical issues with the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had knee pain that limits my activities for at least 3 months.
Select...
I have had knee pain that limits my activities for at least three months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 9, 12, 24, 36-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, 12, 24, 36-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Secondary outcome measures
Change in Range of Motion
Medication Usage
Physical Function: Ability to do one-legged knee bends
+2 moreOther outcome measures
Change in American Knee Society Score
Change in Douleur Neuropathique 4 Questionnaire
Change in Global Perceived Effect Scales
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
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.
Group II: DelayedPlacebo Group1 Intervention
The delayed group will begin 2-hour stimulation/day at the 3-Month visit.
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Who is running the clinical trial?
MiniStim LLCLead Sponsor
Micron Medical CorporationLead Sponsor
4 Previous Clinical Trials
510 Total Patients Enrolled
Uro Medical CorporationLead Sponsor
5 Previous Clinical Trials
520 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are experiencing pain that is rated above 5 on a visual analog scale.I am over 18 years old.I am over 18 years old.I understand the informed consent and study protocol.I cannot get into the required position for treatment or tests.I need regular MRI scans or diathermy treatments for my condition.My body cannot accommodate the placement of a medical device.I have had knee pain that limits my activities for at least 3 months.I have not had knee surgery in the last 3 months.My doctor thinks I am a good candidate for the implant procedure.I have not had knee surgery in the last 3 months.I have had knee pain that limits my activities for at least three months.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Delayed
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this research project for participants?
"As gleaned from clinicaltrials.gov, this medical experiment is actively seeking participants with the original posting date being on May 5th 2021 and the most recent update occurring on July 20th 2022."
Answered by AI
What does this research endeavor hope to achieve?
"Micron Medical Corporation, the study's sponsor, is aiming to measure their main objective over a 3-month period: Rate of Change in Pain Relief of more than 50%, assessed via Visual Analog Scale. In addition to this primary outcome, secondary outcomes such as Physical Function (measured by one-legged knee bends), Range of Motion and Mental Component Score (SF-36 questionnaire) will be evaluated."
Answered by AI
How many participants are currently being recruited for this research project?
"Affirmative. The information available on clinicaltrials.gov verifies that recruitment is currently underway for this trial, which was first posted on May 5th 2021 and most recently changed on July 20th 2022. 350 patients are needed to be enrolled at 1 site."
Answered by AI
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