Identifying factors that predict recovery in children with complex regional pain syndrome
Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome
This study looks at what factors might help predict how well children aged 10 to 17 with Complex Regional Pain Syndrome will recover while they are receiving regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT03838107 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the psychosocial and cerebral markers that may predict the recovery trajectory in pediatric patients suffering from Complex Regional Pain Syndrome (CRPS). Children aged 10 to 17 years, who are undergoing either inpatient or outpatient treatment for CRPS, will be enrolled alongside their parents or guardians. The study will compare various assessments, including fMRI and quantitative sensory testing, between patients and healthy children to identify potential predictors of recovery. Importantly, this study does not involve any treatment interventions but focuses on understanding the factors influencing recovery during standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 10 to 17 years diagnosed with CRPS who are scheduled for standard inpatient or outpatient treatment.
Not a fit: Patients with significant neurological or psychiatric conditions beyond those associated with chronic pain, or those with MRI contraindications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of recovery trajectories in children with CRPS, potentially guiding personalized treatment approaches.
How similar studies have performed: While the study's focus on the interplay of psychosocial and cerebral factors in CRPS is relatively novel, similar studies in chronic pain have shown promising results in understanding recovery trajectories.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Robert C Coghill, PhD — Children's Hospital, Cincinnati
- Study coordinator: Marie-Eve Hoeppli, PhD
- Email: marie-eve.hoeppli@cchmc.org
- Phone: (513)803-1164
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.