Markers of Trajectory in Pediatric CRPS

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT03838107
Status
Recruiting
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Conditions

  • Complex Regional Pain Syndromes

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 27, 2018
Status verified
Feb 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
126 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: Healthy Controls
    For comparison purposes, healthy controls and one of their parents or legal guardian will be enrolled in this study as well.

Primary Outcome Measure

changes in pain perception [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Geraldine Schulze
[email protected]
513-517-0593
Marie-Eve Hoeppli, PhD
[email protected]
(513) 803-1164
Sara E Williams, PhD (SUB_INVESTIGATOR)
Kenneth R Goldschneider, MD (SUB_INVESTIGATOR)
John B Rose, MD (SUB_INVESTIGATOR)

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By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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