Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shanice Saunders
- 전화번호: 888-691-0585
- 이메일: Contact@uromedical.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 활동적인
활성 그룹에 무작위 배정된 피험자, 프로그래밍 매개변수가 설정되고 연구 기간 동안 하루에 최소 2시간 동안 요법이 제공됩니다.
|
모벤티스 PNS는 말초 신경 기원의 중증 난치성 만성 통증이 있는 성인의 통증 관리에 사용된다.
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위약 비교기: 지연
지연된 그룹은 3개월 방문 시 2시간 자극/일을 시작합니다.
|
모벤티스 PNS는 말초 신경 기원의 중증 난치성 만성 통증이 있는 성인의 통증 관리에 사용된다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
기간: 3 Months
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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.
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3 Months
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Adverse Events
기간: 3 Months
|
Device- and procedure-related Adverse Events (AE) rate at 3-months.
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3 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Hip Pain: measured by Hip Pain Questionnaire
기간: 3, 6, 9, 12, 24, 36-months
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Current hip pain will be accessed and the history of hip pain will be recorded.
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3, 6, 9, 12, 24, 36-months
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Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
기간: 6, 9, 12, 24, 36-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.
|
6, 9, 12, 24, 36-Months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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