Neuroimaging of Pain: Changes in Regional Brain Functioning Associated With Amplified Pain and Intensive Treatment

NCT03703921 | Completed

• 1 other identifier: RAPS_fMRI_001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will examine how intensive interdisciplinary pain treatment (IIPT, specifically the Rehabilitation for Amplified Pain Syndrome, or RAPS, program at Children's Mercy Hospital) impacts neurofunctional mechanisms of emotional and physical pain processing in patients. There has been recent interest in characterizing the brain regions responsible for processing pain (Wager et al., 2013), but little research has included youth. A better understanding of the physiological mechanisms of pain can lead to better treatment outcomes.

Conditions

Pain, Chronic

Keywords

Intensive interdisciplinary pain treatment; fMRI; fear of pain

Outcome Measures

Primary Outcomes (1)

• Change in brain response (as measured by fMRI) to viewing images of physical and emotional pain, and experiencing somatosensory simulation to the arm.

  Participants will undergo scanning without intravenous contrast, performed with a 3-Tesla magnetic resonance imaging (MRI) scanner. Structural scan will be completed for spatial normalization and registration with the functional data. Functional scans use blood-oxygen level dependent (BOLD) assessments during active tasks to determine regional brain activation while viewing pictures and experiencing somatosensory stimulation.

  Baseline fMRI will be conducted when the participant starts IIPT. A second scan will be conducted at the end of treatment (3-5 weeks later).

Secondary Outcomes (2)

• Pain Discounting Questionnaire (PDQ)

  Pain Discounting Questionnaire (PDQ), will be completed at the beginning of IIPT (same time as fMRI) and 3-5 weeks later or at the end of the IITP (same time as last fMRI.)

• Fear of Pain Questionnaire (FOPQ), child and parent report

  Fear of Pain Questionnaire (FOPQ), child and parent report will be completed at the beginning of IIPT (same time as fMRI) and 3-5 weeks later or at the end of the IITP (same time as last fMRI.)

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Target study population is youth ages 13-19, regardless of gender, who have been admitted to the RAPS program for intensive treatment. When offered a spot in the RAPS program, patient/parent will be informed about the study and asked if they would like to be contacted to receive more information. Prior to any study procedures, the permission/assent or consent form will be reviewed carefully with the participant (and parent, if applicable).

You may qualify if:

• Age 13 to 19
• Admitted to the RAPS program for intensive treatment

You may not qualify if:

• Inability to participate in imaging due to developmental delay
• Inability or unwillingness to be still during imaging procedures

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Rheumatologist

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 12, 2018
• Study Start: July 9, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)