Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
-
La Mesa, California, 미국, 91942-8901
- Pain Consultants of San Diego
-
Orange, California, 미국, 92868
- Restore Orthopedics and Spine Center
-
-
Delaware
-
Wilmington, Delaware, 미국, 19803
- Center for Interventional Pain and Spine
-
-
Georgia
-
Stockbridge, Georgia, 미국, 30281-5023
- Pain Care
-
-
Maryland
-
Oxon Hill, Maryland, 미국, 20745
- National Spine and Pain
-
-
Michigan
-
Wyoming, Michigan, 미국, 49519
- Michigan Pain Consultants
-
-
Nevada
-
Henderson, Nevada, 미국, 89052
- Comprehensive and Interventional Pain Management
-
-
New Jersey
-
Voorhees, New Jersey, 미국, 08043-3512
- The Pain Management Center
-
-
New York
-
Rochester, New York, 미국, 14618
- University of Rochester Neurosurgery Partners Pain Management
-
-
North Carolina
-
Huntersville, North Carolina, 미국, 28078
- Carolinas Pain Center
-
-
Ohio
-
Columbus, Ohio, 미국, 43210
- The Ohio State University Wexner Medical Center
-
-
Pennsylvania
-
Allentown, Pennsylvania, 미국, 18103
- Lehigh Valley Healthcare Network
-
Bethlehem, Pennsylvania, 미국, 18015
- Saint Luke's Neurosurgical Associates
-
Sewickley, Pennsylvania, 미국, 15134
- Pain Diagnostics and Interventional Care
-
Trevose, Pennsylvania, 미국, 19053
- Delaware Valley Pain and Spine Institute
-
-
South Carolina
-
Charleston, South Carolina, 미국, 29406
- Lowcountry Orthopaedics/Coastal Carolina Research Center
-
Spartanburg, South Carolina, 미국, 29303
- Carolina Center for Advanced Management of Pain
-
-
Texas
-
Tyler, Texas, 미국, 75701
- Precision Spine Care
-
-
Virginia
-
Roanoke, Virginia, 미국, 24014
- Carilion Clinic Roanoke Memorial Hospital
-
-
Washington
-
Spokane, Washington, 미국, 99201
- Northwest Pain Care
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
- Presence of low back and leg pain
- Moderate to crippled disability due to pain
- Stable pain medications for back and leg pain for at least 28 days prior to enrollment
- Willing and able to not increase pain medications through the 3-Month visit
Exclusion Criteria:
- Previously trialed or implanted with stimulator or intrathecal drug delivery system
- Current diagnosis of moderate to severe central lumbar spinal stenosis
- Major psychiatric comorbidity or other progressive diseases
- Serious drug-related behavioral issues
- Pregnant or planning on becoming pregnant
- Unable to achieve supine position
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
|
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
기간: Baseline to 3 months
|
Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain. The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study. |
Baseline to 3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Pain Efficacy Responder Rate
기간: Baseline to 3 months
|
Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders). |
Baseline to 3 months
|
|
Low Back Pain Efficacy Responder Rate
기간: Baseline to 3 months
|
Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders). |
Baseline to 3 months
|
|
Leg Pain Efficacy Responder Rate
기간: Baseline to 3 months
|
Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders). |
Baseline to 3 months
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Vectors Post Market Clinical Research Study Team, Medtronic Restorative Therapies, Pain Therapy
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
만성 통증에 대한 임상 시험
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)