Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03838107 |
| Other study ID # |
2018-1565 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 27, 2018 |
| Est. completion date |
August 31, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Children's Hospital Medical Center, Cincinnati |
| Contact |
Marie-Eve Hoeppli, PhD |
| Phone |
(513)803-1164 |
| Email |
marie-eve.hoeppli[@]cchmc.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
This is a basic science investigation of potential psychosocial, sensory, and brain markers
predicting trajectory of short-term and long-term recovery in pediatric CRPS following both
inpatient and outpatient treatment.
The usual inpatient treatment lasts on average three weeks and includes physical,
occupational, and recreational therapy, as well as psychotherapy, while patients keep their
regular pharmacological treatment. The usual outpatient treatment lasts on average several
months and includes physical therapy and psychotherapy, in addition to pharmacotherapy. For
both inpatients and outpatients, the primary anti-neuropathic pharmacotherapy typically
includes gabapentin, pregabalin, or amitriptyline, or, less frequently, duloxetine. It is
important to note that this study is not designed to investigate the efficacy of treatment
per se, instead it aims to predict trajectory during the course of treatment as usual. This
study is primarily mechanistic and does not include any intervention or modification of
treatments. Therefore, patients, who are scheduled for regular inpatient or outpatient
treatment of CRPS, are free to refuse to enroll without any consequences for the scheduled
treatment.
The investigated markers will be assessed in patients undergoing inpatient or outpatient
treatments. To define potentially relevant markers, measurements in patients will be compared
to the same measurements in healthy children. For this purpose, participants will undergo a
testing session just before the beginning of their treatment or as close as possible from the
beginning of their treatment.
To establish the influence of potential markers on short-term recovery, patients will undergo
an additional session upon completion of their treatment. To investigate the effect of the
previously defined markers on long-term recovery, patients will complete a third session at
six months after treatment. For comparison purposes, healthy control children will undergo
sessions following the same schedule as the patients. To assess the association between
symptoms of CRPS in children and social environment, at least one parent of each enrolled
child will be asked to complete three sessions following the same schedule as their child.
Each testing session will include self-reported questionnaires for the children and their
parents and a brain imaging session for the children.
