Pain, ChronicNCT03703921
Neuroimaging of Pain: Changes in Regional Brain Functioning Associated With Amplified Pain and Intensive Treatment
An observational study of Pain, Chronic, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Pain, Chronic
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- Age 13 to 19
- Admitted to the RAPS program for intensive treatment
Who cannot join
- Inability to participate in imaging due to developmental delay
- Inability or unwillingness to be still during imaging procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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.
Read the 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.
- Conditions
- Pain, Chronic
- Keywords
- Intensive interdisciplinary pain treatment, fMRI, fear of pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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). 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.
Measured: 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.
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start9 Jul 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Hoffart, DO, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703921
- Sponsor's protocol ID
- RAPS_fMRI_001
- Status last verified
- Aug 2020
- First submitted
- 2 Oct 2018
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will be retained at our institution.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging of Pain: Changes in Regional Brain Functioning Associated With Amplified Pain and Intensive Treatment
- ClinicalTrials.gov ID
- NCT03703921
- Acronym / sponsor ID
- RAPS_fMRI_001
- Conditions
- Pain, Chronic
- Keywords
- Intensive interdisciplinary pain treatment, fMRI, fear of pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- Age 13 to 19
- Admitted to the RAPS program for intensive treatment
Key exclusion criteria (2 listed)
- Inability to participate in imaging due to developmental delay
- Inability or unwillingness to be still during imaging procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.)
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: No. Individual data will be retained at our institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.