Actively Recruiting

Age: 10Years - 17Years
All Genders
Healthy Volunteers
ID03838107

Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-02-07

126

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to identify psychosocial factors and brain changes that predict recovery patterns in children aged 10 to 17 years with Complex Regional Pain Syndrome (CRPS), a severe chronic pain condition. The study focuses on how these factors interact and influence short-term and long-term recovery, comparing children undergoing inpatient and outpatient treatment to healthy controls. The goal is to better understand the mechanisms behind CRPS recovery in pediatric patients. Children with CRPS receiving regular inpatient treatment at the FIRST clinic or outpatient treatment at the Pain Management Center will be observed alongside healthy children for comparison. Treatments include physical, occupational, recreational therapy, psychotherapy, and usual pharmacological care. Participants will undergo three sessions: at treatment start, treatment end (about 4 weeks for inpatients and 3 months for outpatients), and six months post-treatment. Healthy controls follow a similar schedule without treatment. During each approximately three-hour session, child participants complete psychosocial questionnaires, psychophysical tests, and brain imaging scans, while parents provide psychosocial data. Researchers will measure changes in pain perception, functional disability, and brain function using advanced imaging techniques at all timepoints. This thorough monitoring helps track recovery trajectories and the impact of various markers over time, with study participation spanning from treatment start to six months after treatment ends.

CONDITIONS

Brief Title

Markers of Trajectory in Pediatric CRPS

Who Can Participate

Age: 10Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged between 10 and 17 years old
  • Fluent in English
  • Diagnosis of CRPS for inpatient and outpatient groups
  • Scheduled for or starting usual inpatient treatment at the FIRST clinic for inpatients
  • Scheduled for or starting usual outpatient treatment at the Pain Management Center for outpatients
  • Healthy children with no chronic pain diagnosis for control group
  • Parent or legal guardian fluent in English and participating with the child
Not Eligible

You will not qualify if you...

  • Weight or size incompatible with MRI scanner
  • Brain, neurological, or severe psychiatric abnormalities beyond those related to chronic pain
  • Documented developmental delays or impairment
  • Any MRI contraindications including braces, stents, clips, pacemakers, or metal implants
  • Pregnancy
  • Claustrophobia preventing MRI scanning

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observation during Treatment

Duration - Approximately 3 weeks for inpatients or several months for outpatients

Participants undergo a testing session just before beginning their usual inpatient or outpatient treatment, which includes psychosocial measures, brain imaging, and sensory testing. Parents also complete questionnaires. This stage covers the duration of the usual treatment period.

1 testing session before treatment and 1 testing session upon completion of treatment

Long-term Monitoring

Duration - 6 months post-treatment

Participants complete a follow-up testing session six months after treatment to assess long-term recovery. Parents also complete a corresponding session.

1 follow-up testing session at 6 months post-treatment

Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

M

Marie-Eve Hoeppli, PhD

G

Geraldine Schulze, BSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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