MiniStim PNS for chronic knee pain relief

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

This study is testing whether the MiniStim PNS device can help people with chronic knee pain feel better by providing pain relief over three months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Uro Medical Corporation (Industry-sponsored)
• Locations: 1 site (Lewisville, Texas)
• Trial ID: NCT04580732 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the MiniStim PNS device in providing pain relief for individuals suffering from chronic knee pain. A total of 300 participants will be randomly assigned to either receive immediate therapy or delayed therapy starting at three months. The primary goal is to achieve more than 50% pain relief at the three-month mark, measured using the Visual Analog Scale (VAS). Participants will be monitored for up to 36 months to assess long-term outcomes and safety.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with chronic knee pain lasting at least three months and a baseline VAS score greater than 5.

Not a fit: Patients with active implantable electronic devices or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic knee pain and improve the quality of life for patients.

How similar studies have performed: While similar approaches have been explored, this specific use of MiniStim PNS for knee pain is relatively novel.

Eligibility criteria

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.

Where this trial is running

Lewisville, Texas

• Seva Medical — Lewisville, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Shanice Saunders

Conditions Chronic Knee Pain