Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation

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.