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Markers of Trajectory in Pediatric CRPS

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ClinicalTrials.gov Identifier: NCT03838107
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Chapman Family Donation
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:

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.


Condition or disease Intervention/treatment
Complex Regional Pain Syndromes Behavioral: observation and measure of trajectory of recovery in CRPS

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Behavioral: observation and measure of trajectory of recovery in CRPS
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.

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.
Behavioral: observation and measure of trajectory of recovery in CRPS
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.

Healthy Controls
For comparison purposes, healthy controls and one of their parents or legal guardian will be enrolled in this study as well.
Behavioral: observation and measure of trajectory of recovery in CRPS
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838107


Contacts
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Contact: Marie-Eve Hoeppli, PhD (513)803-1164 marie-eve.hoeppli@cchmc.org
Contact: Eric Leon, BSc (513) 348-0850 Eric.Leon@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Eric Leon    513-348-0850    eric.leon@cchmc.org   
Contact: Marie-Eve Hoeppli, PhD    (513) 803-1164    marie-eve.hoeppli@cchmc.org   
Sub-Investigator: Sara E Williams, PhD         
Sub-Investigator: Kenneth R Goldschneider, MD         
Sub-Investigator: John B Rose, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Chapman Family Donation
Investigators
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Principal Investigator: Robert C Coghill, PhD Children's Hospital, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03838107     History of Changes
Other Study ID Numbers: 2018-1565
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
pediatric complex regional pain syndrome
fMRI
psychosocial
quantitative sensory testing
markers

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases