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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703921
• Other study ID #: RAPS_fMRI_001
• Status: Completed
• Start date: July 9, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: August 2020
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.)
Secondary	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.)