- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07602595
The BRIDGE Pain Study (BRIDGE)
Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain
The purpose of the study is to discover at least two distinct Musculoskeletal pain subtypes. These types are caused by different brain-and-immune system signals that affect how the body feels pain, and they are also shaped by a person's biology, psychology, and social environment.
Aim 1. We want to sort adolescents and young adults with long lasting muscle and bone pain into two different groups. To do this, we will look at participants' childhood medical histories, past treatments, when their pain started, the sex they were assigned at birth, what their pain feels like now, tests of how their body senses pain, and immune system markers found in their blood. We think we will find at least two different types of chronic pain groups, plus one group of patients who had a higher risk for pain (because of a rheumatic disease or past surgery) but never developed long term pain.
Aim 2. We want to find out if certain patterns of inflammation in the body change how nerve cells react to pain.
Aim 3: We want to understand how different biological, psychological, and social factors are connected to the chronic pain groups we identified. We think we will find certain mental, behavioral, and social risks-as well as protective factors-that help explain why some people develop long-lasting pain and others do not. We expect these factors to play different roles in each pain group, including the group that does not develop chronic pain.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Megan Kirschman
- 전화번호: 5136361846
- 이메일: bridgestudy@cchmc.org
연구 장소
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45211
- 모병
- Cincinnati Children's Hospital
-
연락하다:
- Megan Kirschman
- 전화번호: 5136361846
- 이메일: bridgestudy@cchmc.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Diagnosis of rheumatic/autoimmune disease/pain condition or surgery prior to age 18; Current age 14 to 26 years; Participant (and parent/legal guardian of participants < 18 yo) can read and write in English; At least 1 year from diagnosis of pain or rheumatic disease; For individuals with MSK surgical history, at least 1 year after initial surgical intervention; For individuals with rheumatic disease, their disease must be considered inactive
Exclusion Criteria:
- They have active disease, or Other major medical comorbidities have developed after surgery following MSK surgical intervention.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Primary musculoskeletal pain disorders
localized or widespread MSK pain
|
This is an observational study.
No intervention is present.
|
|
Inflammatory/autoimmune rheumatic diseases
juvenile idiopathic arthritis (JIA) and childhood-onset systemic lupus erythematosus (cSLE)
|
This is an observational study.
No intervention is present.
|
|
Major MSK surgeries
scoliosis and pectus excavatum repair
|
This is an observational study.
No intervention is present.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Conditioned Pain Modulation (CPM) Profile (Pressure)
기간: Baseline
|
CPM is defined by the change in pressure thresholds (increase) before and during cold immersion.
Pressure thresholds will be measured using an algometer.
|
Baseline
|
|
Conditioned Pain Modulation (CPM) Profile (Heat)
기간: Baseline
|
CPM is defined by the change in heat pain intensity (decrease) before and during cold immersion.
Heat stimuli will be delivered by a thermode and pain intensity measured by participant self report on the visual analog scale.
|
Baseline
|
|
Temporal Summation (TS) Profile
기간: Baseline
|
TS is defined by the change in mechanical pain intensity (increase) after exposure to a series of pinprick stimuli.
Pain intensity will be measured by participant self report on the visual analog scale.
|
Baseline
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BRIDGE Pain
- 1UC2AR086503 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .