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NCT03838107 · ClinicalTrials.gov registry record

Markers of Trajectory in Pediatric CRPS

A clinical trial of Complex Regional Pain Syndromes, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
126
Enrollment target
1
Study location

NCT03838107 is a study of Complex Regional Pain Syndromes that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 126 participants, above the 88-participant average among 7 other Complex Regional Pain Syndromes trials with a reported enrollment target (43% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT03838107, a study of Complex Regional Pain Syndromes, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
126 participants
Enrollment target
1
Study location

Study Summary

Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between these cerebral changes and trajectory of recovery has been seldom investigated to date. Furthermore, interactions between cerebral changes and psychosocial factors, which might affect trajectory of recovery, are unknown. The aim of this study is to identify the psychosocial factors and cerebral changes that predict the trajectory of recovery from CRPS. Children between the ages of 10 and 17 years will be enrolled with one of their parents or legal guardians for this study. Three populations will be recruited: patients with CRPS undergoing treatment at the Functional Independence Restoration Program (FIRST), patients with CRPS undergoing treatment at the Pain Management Center and matching healthy controls. Participants will undergo three sessions: the first session will be scheduled immediately before or as soon as possible at the beginning of the patients' treatment; the second session will take place at the end of the patients' treatment; the last session will be scheduled six months post-treatment. The timing of the sessions of the healthy participants will follow a schedule similar to the FIRST patients. Each session will last approximately three hours and include acquisition of psychosocial, psychophysical, and brain imaging data in the child participants, as well as acquisition of psychosocial data in the parent participants.

Interventions

  • BEHAVIORAL observation and measure of trajectory of recovery in CRPS

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2018-08-27
Est. Completion 2026-08-31

What the Registry Record Tells You About NCT03838107

The ClinicalTrials.gov registry entry for NCT03838107 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 88-participant average among 7 other Complex Regional Pain Syndromes trials with a reported enrollment target (43% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Complex Regional Pain Syndromes appearing as the primary indexed condition, and to 1 intervention - of which observation and measure of trajectory of recovery in CRPS is the first listed.

NCT03838107 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT03838107 about?

NCT03838107 is a clinical study titled "Markers of Trajectory in Pediatric CRPS". Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between...

What is the current status of trial NCT03838107?

This trial is currently recruiting. The enrollment target is 126 participants. The study started on 2018-08-27. Estimated completion is 2026-08-31.

What conditions does trial NCT03838107 study?

This clinical trial studies the following conditions: Complex Regional Pain Syndromes.

What interventions are being tested in trial NCT03838107?

The interventions under investigation include: observation and measure of trajectory of recovery in CRPS (BEHAVIORAL).

Who is sponsoring clinical trial NCT03838107?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03838107 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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