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임상시험 NCT03910010은(는) 섬유근육통에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Brain Imaging Study on Biomarkers for Fibromyalgia 35 정밀 의학 바이오마커 기반 예방
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT03910010은(는) 섬유근육통에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2021년 2월 1일에 시작되어 35명의 참여자를 모집하고 있습니다. Nova Scotia Health Authority이(가) 진행하며, 2035년 1월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 8월 22일에 갱신되었습니다.
간단한 개요
Drugs used for managing Fibromyalgia pain have not proven to be effective and pain continues to cost Canadians $60 billion a year without truly helping those who suffer. The study proposes to investigate the factors related to a person that can enhance or reduce the effectiveness of pain treatments in people suffering with Fibromyalgia pain. Treatment response to painkillers in a person may be related to their brain,...더 보기
공식 제목
Brain Imaging Study on Biomarkers for Fibromyalgia
질환명
섬유근육통기타 연구 식별자
- 5748
NCT 번호
실제 연구 시작일
2021-02-01
최신 업데이트 게시
2024-08-22
예상 연구 완료일
2035-01
계획된 등록 인원
35
연구종류
중재연구
단계/상
해당 없음
상태
모집중
주요 목적
건강 서비스 연구
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Experimental: placebos Fibromyalgia participants will enter in an optional placebo trial. This phase of the study will test the clinical usefulness of the biomarkers. We will measure how expectation of starting a new treatment reduces 'clinical back pain' in each participant. Positive treatment expectations will be induced by giving them capsules containing inert material and telling them that the capsules contain an effective drug that ha...더 보기 | 위약들 Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Pain. They will be requested to take two capsules four times a day and report their pain on paper forms organized as a calendar or on REDCap. |
비개입Waitlist Fibromyalgia participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar or on REDCap. | 해당 없음 |
비개입Healthy Controls Healthy control participants will complete the main part of the study, but will not be asked to take a placebo or be placed on a waitlist. | 해당 없음 |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
pain modulation- using an experimental task that tests a person's ability to form positive expectations. | Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations. | 3 days after first visit |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
Chronic pain participant inclusion criteria:
- 18-75 years of age
- Right-handed
- Meet the classification criteria of chronic low back pain (having low back pain for more than 6 months).
- At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the two weeks prior to enrollment
- Comfortable completing (reading and writing) questionnaires and tasks with English language instructions
Healthy participant inclusion criteria:
- 18 - 75 years of age
- Right-handed
- Comfortable completing (reading and writing) questionnaires and tasks with English language instructions
Chronic pain participant exclusion criteria:
- History of cardiac, respiratory, or nervous system disease that may interfere with participation in the study or cause heightened potential for adverse outcome. For example: asthma or claustrophobia
- Presence of any contraindications to MRI scanning. For example:
cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
Healthy participant exclusion criteria:
- Acute or chronic pain
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment and by asking the participant about their comfort level and ability, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia
- Presence of any contraindications to MRI scanning. For example:
cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Nova Scotia Health Authority연구 대표 연락처
연락처: Javeria A Hashmi, PhD, 902-473-4603, [email protected]
1 1개국에 임상시험 장소
Nova Scotia
Nova Scotia Health Authority, Halifax, Nova Scotia, B3h1V7, Canada
모집중