Clinical Trial of the MiniStim PNS for Knee Pain- "FLEX" Study
Status unconfirmed · Not applicable
Conditions studied: Chronic Knee Pain
In brief
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.
Key facts
- Study ID
- NCT04580732
- Run by
- MiniStim LLC
- People needed
- 350
- Starts
- 2021-05-05
- Expected to finish
- 2025-11-01
- Last updated by the study team
- 2023-10-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Seva Medical — Lewisville, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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