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

This trial accepts healthy volunteers

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 population

Participants to this study may be part of one of the following groups: children diagnosed with CRPS undergoing inpatient treatment at the FIRST clinic (CCHMC), children diagnosed with CRPS underdoing outpatient treatment at the pain management clinic (CCHMC or comparable outpatient programs), or healthy children. The investigator's groups will be matched as well as possible for BMI, sex, and age. In addition, one parent will be recruited with each child.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

observation and measure of trajectory of recovery in CRPS
Behavioral
Child participants enrolled in this study will undergo three sessions, which will include psychosocial measures, brain imaging, and quantitative sensory testing. Parent participants will also complete three sessions, which only include psychosocial measures.

Treatment groups

126 Participants

are divided into 3 treatment groups

Group A: Inpatients1 intervention

Group B: Outpatients1 intervention

Group C: Healthy Controls1 intervention

Trial outcomes

Primary outcomes

1

changes in pain perception

changes in ratings of spontaneous pain intensity and unpleasantness assessed on non-numerical visual analog scales, ranging from 'no pain sensation'/'not at all unpleasant' to 'most intense pain sensation imaginable'/'most unpleasant imaginable'

Time frame