Understanding Recovery in Pediatric Complex Regional Pain Syndrome (CRPS)

This study is looking at children aged 10 to 17 with Complex Regional Pain Syndrome (CRPS), a severe and complex chronic pain condition. Researchers want to understand what factors, including brain changes and personal experiences, predict how well children recover from CRPS. You would participate in three sessions, which include psychosocial measures (like questionnaires about feelings and experiences), brain imaging, and sensory tests. Parents also complete three sessions of psychosocial measures. The study aims to see how pain perception and ability to function change over time, both before and after usual CRPS treatment, and up to six months later. This is an observational study, meaning it doesn't involve new treatments, but rather observes patients undergoing their regular care.

Study design
This is an observational study involving 126 participants. It is not randomized or blinded.
What's involved
Child participants will have three sessions involving psychosocial measures, brain imaging, and quantitative sensory testing. Parent participants will complete three sessions of psychosocial measures.
Compensation
Not stated in the trial record.
Follow-up
Pain perception and functional disability will be measured up to six months after treatment for patients, and six months after the second session for healthy participants.

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NCT03838107

Markers of Trajectory in Pediatric CRPS

UNKNOWN
Not specifiedAges 10–17Observational
Children's Hospital Medical Center, Cincinnati
~126 participants
Updated 2024-02-07 on ClinicalTrials.gov
What's tested:observation and measure of trajectory of recovery in CRPS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
changes in pain perception
Measured over before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
+1 more outcome measured
Complex Regional Pain Syndromes
1 sites across 1 states
Ohio1
  • Robert C Coghill, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital, Cincinnati

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Eligibility criteria

Inclusion

Age between 10 and 17 years old
Fluent in English
Diagnosis of CRPS
Former unsuccessful treatment for CRPS
Scheduled for or beginning the usual inpatient treatment for CRPS at the FIRST clinic at CCHMC.
Diagnosis of CRPS
Scheduled for or beginning the usual outpatient treatment for CRPS at the pain management clinic
Fluent in English
Child participating in the study

Exclusion

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
Braces, stents, clips, pace-maker or other metal implants affecting the safety of the participants in the scanner and/or the quality of the images
pregnancy
claustrophobia
  • changes in pain perceptionbefore treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants

    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'

  • Changes in functional disabilitybefore treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants

    Changes in scores on the self-reported Functional Disability Inventory investigates disabilities associated with pain which might impact on everyday functioning of children. It includes 15 questions assessing the children's capacity to perform everyday tasks, such as doing chores, walking, or eating regular meals. Participants evaluate their capacity to perform these tasks on Likert-type scale, ranging from "No Trouble" to "Impossible".