Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: t
View:

⁃ All Children:

• Age between 10 and 17 years old

• Fluent in English

⁃ Inpatients:

• Diagnosis of CRPS

• Former unsuccessful treatment for CRPS

• Scheduled for or beginning the usual inpatient treatment for CRPS at the FIRST clinic at CCHMC.

⁃ Outpatients:

• Diagnosis of CRPS

• Scheduled for or beginning the usual outpatient treatment for CRPS at the pain management clinic

⁃ Healthy children:

⁃ \- No diagnosis of chronic pain.

⁃ Parents:

• Fluent in English

• Child participating in the study

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Marie-Eve Hoeppli, PhD
marie-eve.hoeppli@cchmc.org
(513)803-1164
Backup
Geraldine Schulze, BSc
Geraldine.Schulze@cchmc.org
(513) 517-0593
Time Frame
Start Date: 2018-08-27
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 126
Treatments
Inpatients
Observation and measure of trajectory of recovery in CRPS. This group will include children diagnosed with CRPS and undergoing regular therapy at the inpatient FIRST clinic at CCHMC and one of their parents or legal guardian.
Outpatients
Observation and measure of trajectory of recovery in CRPS. This group will include children diagnosed with CRPS and undergoing regular therapy at the outpatient Pain Management Center at CCHMC and one of their parents or legal guardian.
Healthy Controls
For comparison purposes, healthy controls and one of their parents or legal guardian will be enrolled in this study as well.
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov