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NCT Number: NCT03838107

Markers of Trajectory in Pediatric CRPS

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.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Geraldine Schulze

CONTACT

[email protected]

513-517-0593

John B Rose, MD

SUB_INVESTIGATOR

Kenneth R Goldschneider, MD

SUB_INVESTIGATOR

Marie-Eve Hoeppli, PhD

CONTACT

[email protected]

(513) 803-1164

Sara E Williams, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All Children:

  • Age between 10 and 17 years old
  • Fluent in English

Inpatients:

  • Diagnosis of CRPS
  • Former unsuccessful treatment for CRPS
  • Scheduled for or beginning the usual inpatient treatment for CRPS at the FIRST clinic at CCHMC.

Outpatients:

  • Diagnosis of CRPS
  • Scheduled for or beginning the usual outpatient treatment for CRPS at the pain management clinic

Healthy children:

  • No diagnosis of chronic pain.

Parents:

  • Fluent in English
  • Child participating in the study

Exclusion criteria

All child participants:

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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'

  2. Changes in functional disability

    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

    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".

Secondary outcomes

  1. Changes in functional Magnetic Resonance Imaging (fMRI) BOLD (Blood Oxygenation Level Dependent) and pCASL (pseudo-Continuous Arterio-Spin Labeling) resting-state and task-related brain signal

    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

    fMRI BOLD and PCASL will be used to measure changes in brain activation at rest and during a multisensory task

  2. changes in fMRI BOLD and pCASL resting-state functional connectivity

    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

    fMRI BOLD and pCASL will be used measure of changes in functional connectivity at rest

  3. changes in DTI (Diffusion Tensor Imaging) structural connectivity

    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

    Diffusion tensor imaging will be used to measure changes in structural connectivity

Study contacts

Contact information is provided by the study sponsor or research team.

Geraldine Schulze, BSc

CONTACT

[email protected]

(513) 517-0593

Marie-Eve Hoeppli, PhD

CONTACT

[email protected]

(513)803-1164

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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