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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic

Detailed Description

Youth will be scanned before or during the first week of participation in the Rehabilitation for Amplified Pain Syndrome (RAPS) program, and a second time near or just after program completion (typically 3-5 weeks later). One functional MRI task will involve passive viewing of emotional and pain-related images including some that have been widely used in previous neuroimaging research (e.g., the International Affective Picture Set, Human Facial Expressions; alternating positive and negative affect/valence). The other functional MRI task, will involve systematic external application of somatosensory stimulation (pressure) to the hand in alternating blocks. The entire imaging procedure will take approximately an hour. MRI technicians and/or study staff will administer the scanning protocol. Study team will be responsible for the systematic external application of sensory input.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Discounting Questionnaire (PDQ)	- Pain Discounting Questionnaire (PDQ). This measures the extent to which later rewards (in this case pain relief) lose value related to the delay (being a number of days later). - This was adapted from the 27-item Monetary-Choice Questionnaire. Scoring procedures include calculating the value of k (hyperbolic discount parameter) for small, medium, and large delays. Using the geometric mean of responses allows for a single score if necessary. The values of k ranges from 0-1. - Greater values indicate more delay discounting, or more tendency to value a sooner, smaller reward rather than wait for a later, larger reward. Subscales are not combined.	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, child report (FOPQ-C) and Fear of Pain Questionnaire, parent proxy report (FOPQ-P). These each measures the extent to which youth with chronic pain experience cognitive and physiological signs of fear when experiencing pain. Scale ranges: - FOPQ-C total: 24 items, range 0-96, FOPQ-C fear of pain: 13 items, range 0-52, FOPQ-C avoidance of activities: 11 items, range 0-44, FOPQ-P total: 21 items, range 0-84, FOPQ-P fear of pain: 8 items, range 0-32, FOPQ-P avoidance of activities: 10 items, range 0-40, FOPQ-P school avoidance: 5 items, range 0-20. For all total scores and subscales, greater scores indicate more fear of pain. For both the FOPQ-C and FOPQ-P, the total scores indicate a sum of all items.	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.)

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: fMRI; Intensive interdisciplinary pain treatment; fear of pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: RAPS_fMRI_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will be retained at our institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No