Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
126 participants
OBSERVATIONAL
2018-08-27
2026-08-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Robert C Coghill, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-1565
Identifier Type: -
Identifier Source: org_study_id
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