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

August 5, 2020 updated by: Cara Hoffart, DO, Children's Mercy Hospital Kansas City
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Discounting Questionnaire (PDQ)
Time Frame: 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.)
- 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
Time Frame: 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.)
- 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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