此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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.

研究概览

研究类型

观察性的

注册 (估计的)

600

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ohio
      • Cincinnati、Ohio、美国、45211
        • 招聘中
        • Cincinnati Children's Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

The participants in this study will come from several groups at Cincinnati Children's Hospital. These include teens and young adults with long-lasting widespread pain, patients already taking part in chronic muscle and bone pain studies, patients with childhood rheumatic diseases, and patients who have had major muscle or bone surgeries. If we need more participants, we will also recruit from the hospital's rheumatology and pain clinics. We plan to enroll 600 adolescents and young adults, ages 14 to 26, with equal numbers from each of the three study groups.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Conditioned Pain Modulation (CPM) Profile (Pressure)
大体时间: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)
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2029年8月1日

研究完成 (估计的)

2029年8月1日

研究注册日期

首次提交

2026年5月16日

首先提交符合 QC 标准的

2026年5月16日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月16日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅