Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Uro Medical Corporation
- Enrollment
- 300
- Primary Endpoint
- Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Study Overview
Brief Summary
This is a prospective, randomized, multi-center study in which 300 evaluable subjects will be randomized 1:1 to receive Active or Delayed therapy with Moventis PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up.
Detailed Description
This is a prospective, randomized, controlled, multi-center study in which 300 evaluable subjects will receive Moventis PNS. Target subjects will have idiopathic hip pain.
Subjects will be randomized into either a delayed or immediate continuation 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 is to demonstrate clinically significant improvements in the pain of patients in the active group compared to the subjects in the delayed group. The primary endpoint is defined as >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications. Improvement will be assessed in relation to the clinical outcome measures of pain, with a target of >50% pain relief.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Capable of giving informed consent;
- •Capable and willing to follow all study related procedures;
- •Women and men >18 years of age;
- •Diagnosis of hip pain;
- •Baseline VAS score of >5;
- •>50% temporary relief from temporary nerve diagnostic evaluation;
- •No evidence of anatomic abnormalities that could jeopardize device placement;
- •Able to operate programmer, recharger, study assessments and provide accurate responses;
- •Appropriate candidate for the implant procedure.
Exclusion Criteria
- •An active implantable electronic device regardless of whether stimulation is ON or OFF;
- •Pregnant or plan to become pregnant during study;
- •Less than 1-year post-partum and/or are breast-feeding;
- •Symptoms existing for less than 6 months;
- •Multiple complaints that will not be amenable to study;
- •Current diagnosis of a Neurological disease;
- •Daily opioid usage exceeding CDC recommendations;
- •Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
- •Conditions requiring recurring MRI evaluation or diathermy procedures;
- •Uncontrolled diabetes (HbA1C > 8.5);
- •Known or suspected substance abuse within the last 2-years;
- •Uncontrolled major depression or uncontrolled psychiatric disorders;
- •Worker's compensation claimants;
- •History of adverse reaction to local anesthetic drugs;
- •History of coagulopathy or bleeding disorder;
- •Anatomical restrictions such that device placement is not possible;
- •Chronic or acute conditions that could interfere with the interpretations of the outcome assessment for pain and bodily function;
- •Have a life expectancy of less than 1-year;
- •Neurogenic or vascular claudication;
- •Inability to achieve appropriate positioning and inability to understand informed consent and protocol;
- •Deemed unsuitable for enrollment by investigator based on history or physical examination.
Arms & Interventions
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.
Intervention: Moventis PNS (Device)
Delayed
The delayed group will begin 2-hour stimulation/day at the 3-Month visit.
Intervention: Moventis PNS (Device)
Outcomes
Primary Outcomes
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.
Adverse Events
Time Frame: 3 Months
Device- and procedure-related Adverse Events (AE) rate at 3-months.
Secondary Outcomes
- Change in Hip Pain: measured by Hip Pain Questionnaire(3, 6, 9, 12, 24, 36-months)
- Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale(6, 9, 12, 24, 36-Months)