Markers of Trajectory in Pediatric CRPS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-17
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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 criteria

Qualifiers

Age between 10 and 17 years old

Fluent in English

Diagnosis of CRPS

Former unsuccessful treatment for CRPS

Disqualifiers

Weight/size incompatible with MRI scanner

Identification of brain, neurologic, or severe psychiatric abnormalities beyond those normally associated with chronic pain.

Documented developmental delays or impairment

Any MRI contra-indication, including

Trial design

Treatments tested in this trial

  • observation and measure of trajectory of recovery in CRPS

Treatment groups

126 Participants
are divided into 3 treatment groups