High-density in Spinal Cord Stimulation: Virtual Expert Registry (Discover)
2021년 1월 28일 업데이트: Moens Maarten, Universitair Ziekenhuis Brussel
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
연구 개요
상세 설명
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain.
Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
연구 유형
관찰
등록 (실제)
272
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Brussel, 벨기에
- UZ Brussel
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.
설명
Inclusion Criteria:
- Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
- Age > 18 years
- Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- Patient has been informed of the study procedures and has given written informed consent
- Patient willing to comply with study protocol including attending the study visits
Exclusion Criteria:
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Immune deficiency (HIV positive, immunosuppressiva, etc.)
- Life expectancy < 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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spinal cord stimulation
Failed back surgery syndrome patients will receive high density spinal cord stimulation
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain intensity with the Numeric Rating Scale (NRS)
기간: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Pain relief by pain medication
기간: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire regarding the amount of pain relief by pain medication
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The abilities in daily living
기간: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The current health status
기간: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Subjective sleep quality
기간: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient's satisfaction
기간: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain area coverage
기간: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The patient has to draw the areas of pain coverage on a body shape figure
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Paresthesia threshold
기간: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient indicates the threshold at which he experiences paresthesia
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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HD stim parameters
기간: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire towards the clinician regarding the ideal high density parameters for this patient
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Battery efficiency of the neurostimulator
기간: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The battery usage will be measured by frequencies to recharge the battery.
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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AdaptiveStim use (in case of Restore Sensor)
기간: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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MRI need
기간: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire regarding the need for MR scans for other medical conditions
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6.
- Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
- Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.
- Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 6월 1일
기본 완료 (실제)
2020년 12월 8일
연구 완료 (실제)
2020년 12월 8일
연구 등록 날짜
최초 제출
2016년 5월 26일
QC 기준을 충족하는 최초 제출
2016년 5월 26일
처음 게시됨 (추정)
2016년 6월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 2월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 28일
마지막으로 확인됨
2021년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Discover1
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. .
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