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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;

Must not have

Inability to understand informed consent and protocol

Inability to achieve appropriate positioning

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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 below

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I have had knee pain that limits my activities for at least 3 months.

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I have had knee pain that limits my activities for at least three months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand the informed consent and study protocol.

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I cannot get into the required position for treatment or tests.

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I need regular MRI scans or diathermy treatments for my condition.

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My body cannot accommodate the placement of a medical device.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12, 24, 36-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

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

Secondary study objectives

Change in Range of Motion

Medication Usage

Physical Function: Ability to do one-legged knee bends

+2 more

Other study objectives

Change in American Knee Society Score

Change in Douleur Neuropathique 4 Questionnaire

Change in Global Perceived Effect Scales

+7 more

Trial 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.

0 / 6Eligibility criteria met