- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Megan Kirschman
- Phone Number: 5136361846
- Email: bridgestudy@cchmc.org
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45211
- Recruiting
- Cincinnati Children's Hospital
-
Contact:
- Megan Kirschman
- Phone Number: 5136361846
- Email: bridgestudy@cchmc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conditioned Pain Modulation (CPM) Profile (Pressure)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Bone Diseases
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Spinal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Bone Diseases, Developmental
- Spinal Curvatures
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Arthritis, Juvenile
- Musculoskeletal Pain
- Fibromyalgia
- Chronic Pain
- Scoliosis
- Funnel Chest
Other Study ID Numbers
- BRIDGE Pain
- 1UC2AR086503 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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