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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Megan Kirschman
- 電話番号：5136361846
- メール：bridgestudy@cchmc.org
研究場所
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Ohio
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Cincinnati、Ohio、アメリカ、45211
- 募集
- Cincinnati Children's Hospital
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コンタクト：
- Megan Kirschman
- 電話番号：5136361846
- メール：bridgestudy@cchmc.org
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Primary musculoskeletal pain disorders
localized or widespread MSK pain
|
This is an observational study.
No intervention is present.
|
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Inflammatory/autoimmune rheumatic diseases
juvenile idiopathic arthritis (JIA) and childhood-onset systemic lupus erythematosus (cSLE)
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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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Conditioned Pain Modulation (CPM) Profile (Pressure)
時間枠：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
|
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Conditioned Pain Modulation (CPM) Profile (Heat)
時間枠：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
|
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Temporal Summation (TS) Profile
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BRIDGE Pain
- 1UC2AR086503 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。