Complex Regional Pain SyndromesNCT03838107
Markers of Trajectory in Pediatric CRPS
An observational study of Complex Regional Pain Syndromes, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- observation and measure of trajectory of recovery in CRPS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 31 Aug 2026
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants to this study may be part of one of the following groups: children diagnosed with CRPS undergoing inpatient treatment at the FIRST clinic (CCHMC), children diagnosed with CRPS underdoing outpatient treatment at the pain management clinic (CCHMC or comparable outpatient programs), or healthy children. The investigator's groups will be matched as well as possible for BMI, sex, and age. In addition, one parent will be recruited with each child.
Who may be able to join
- All Children:
- Age between 10 and 17 years old
- Fluent in English
- Inpatients:
- Diagnosis of CRPS
- Former unsuccessful treatment for CRPS
Show all 15Show fewer
- Scheduled for or beginning the usual inpatient treatment for CRPS at the FIRST clinic at CCHMC.
- Outpatients:
- Diagnosis of CRPS
- Scheduled for or beginning the usual outpatient treatment for CRPS at the pain management clinic
- Healthy children:
- No diagnosis of chronic pain.
- Parents:
- Fluent in English
- Child participating in the study
Who cannot join
- All child participants:
- Weight/size incompatible with MRI scanner
- Identification of brain, neurologic, or severe psychiatric abnormalities beyond those normally associated with chronic pain.
- Documented developmental delays or impairment
- Any MRI contra-indication, including
- Braces, stents, clips, pace-maker or other metal implants affecting the safety of the participants in the scanner and/or the quality of the images
- pregnancy
- claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Geraldine Schulze, 513-517-0593, Geraldine.Schulze@cchmc.org
Marie-Eve Hoeppli, PhD, (513) 803-1164, marie-eve.hoeppli@cchmc.org
About this study
Official title: Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome
Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between these cerebral changes and trajectory of recovery has been seldom investigated to date. Furthermore, interactions between cerebral changes and psychosocial factors, which might affect trajectory of recovery, are unknown. The aim of this study is to identify the psychosocial factors and cerebral changes that predict the trajectory of recovery from CRPS.
Children between the ages of 10 and 17 years will be enrolled with one of their parents or legal guardians for this study. Three populations will be recruited: patients with CRPS undergoing treatment at the Functional Independence Restoration Program (FIRST), patients with CRPS undergoing treatment at the Pain Management Center and matching healthy controls. Participants will undergo three sessions: the first session will be scheduled immediately before or as soon as possible at the beginning of the patients' treatment; the second session will take place at the end of the patients' treatment; the last session will be scheduled six months post-treatment. The timing of the sessions of the healthy participants will follow a schedule similar to the FIRST patients. Each session will last approximately three hours and include acquisition of psychosocial, psychophysical, and brain imaging data in the child participants, as well as acquisition of psychosocial data in the parent participants.
Read the detailed description
This is a basic science investigation of potential psychosocial, sensory, and brain markers predicting trajectory of short-term and long-term recovery in pediatric CRPS following both inpatient and outpatient treatment.
The usual inpatient treatment lasts on average three weeks and includes physical, occupational, and recreational therapy, as well as psychotherapy, while patients keep their regular pharmacological treatment. The usual outpatient treatment lasts on average several months and includes physical therapy and psychotherapy, in addition to pharmacotherapy. For both inpatients and outpatients, the primary anti-neuropathic pharmacotherapy typically includes gabapentin, pregabalin, or amitriptyline, or, less frequently, duloxetine. It is important to note that this study is not designed to investigate the efficacy of treatment per se, instead it aims to predict trajectory during the course of treatment as usual. This study is primarily mechanistic and does not include any intervention or modification of treatments. Therefore, patients, who are scheduled for regular inpatient or outpatient treatment of CRPS, are free to refuse to enroll without any consequences for the scheduled treatment.
The investigated markers will be assessed in patients undergoing inpatient or outpatient treatments. To define potentially relevant markers, measurements in patients will be compared to the same measurements in healthy children. For this purpose, participants will undergo a testing session just before the beginning of their treatment or as close as possible from the beginning of their treatment.
To establish the influence of potential markers on short-term recovery, patients will undergo an additional session upon completion of their treatment. To investigate the effect of the previously defined markers on long-term recovery, patients will complete a third session at six months after treatment. For comparison purposes, healthy control children will undergo sessions following the same schedule as the patients. To assess the association between symptoms of CRPS in children and social environment, at least one parent of each enrolled child will be asked to complete three sessions following the same schedule as their child.
Each testing session will include self-reported questionnaires for the children and their parents and a brain imaging session for the children.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- observation and measure of trajectory of recovery in CRPS
- Keywords
- pediatric complex regional pain syndrome, fMRI, psychosocial, quantitative sensory testing, markers
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation and measure of trajectory of recovery in CRPSBehavioural
Child participants enrolled in this study will undergo three sessions, which will include psychosocial measures, brain imaging, and quantitative sensory testing. Parent participants will also complete three sessions, which only include psychosocial measures.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients | Observation and measure of trajectory of recovery in CRPS. This group will include children diagnosed with CRPS and undergoing regular therapy at the inpatient FIRST clinic at CCHMC and one of their parents or legal guardian. Receives: Behavioral: observation and measure of trajectory of recovery in CRPS | |
| Outpatients | Observation and measure of trajectory of recovery in CRPS. This group will include children diagnosed with CRPS and undergoing regular therapy at the outpatient Pain Management Center at CCHMC and one of their parents or legal guardian. Receives: Behavioral: observation and measure of trajectory of recovery in CRPS | |
| Healthy Controls | For comparison purposes, healthy controls and one of their parents or legal guardian will be enrolled in this study as well. Receives: Behavioral: observation and measure of trajectory of recovery in CRPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in pain perception
changes in ratings of spontaneous pain intensity and unpleasantness assessed on non-numerical visual analog scales, ranging from 'no pain sensation'/'not at all unpleasant' to 'most intense pain sensation imaginable'/'most unpleasant imaginable'
Measured: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
Changes in functional disability
Changes in scores on the self-reported Functional Disability Inventory investigates disabilities associated with pain which might impact on everyday functioning of children. It includes 15 questions assessing the children's capacity to perform everyday tasks, such as doing chores, walking, or eating regular meals. Participants evaluate their capacity to perform these tasks on Likert-type scale, ranging from "No Trouble" to "Impossible".
Measured: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
Secondary outcomes (3)
Changes in functional Magnetic Resonance Imaging (fMRI) BOLD (Blood Oxygenation Level Dependent) and pCASL (pseudo-Continuous Arterio-Spin Labeling) resting-state and task-related brain signal
fMRI BOLD and PCASL will be used to measure changes in brain activation at rest and during a multisensory task
Measured: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
changes in fMRI BOLD and pCASL resting-state functional connectivity
fMRI BOLD and pCASL will be used measure of changes in functional connectivity at rest
Measured: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
changes in DTI (Diffusion Tensor Imaging) structural connectivity
Diffusion tensor imaging will be used to measure changes in structural connectivity
Measured: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start27 Aug 2018
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert C Coghill, PhD, Principal investigator, Children's Hospital, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838107
- Sponsor's protocol ID
- 2018-1565
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2018
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT03838107
- Acronym / sponsor ID
- 2018-1565
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- pediatric complex regional pain syndrome, fMRI, psychosocial, quantitative sensory testing, markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Feb 2019 (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.
Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between these cerebral changes and trajectory of recovery has been seldom investigated to date. Furthermore, interactions between cerebral changes and psychosocial factors, which might affect trajectory of recovery, are unknown. The aim of this study is to identify the psychosocial factors and cerebral changes that predict the trajectory of recovery from CRPS.
Children between the ages of 10 and 17 years will be enrolled with one of their parents or legal guardians for this study. Three populations will be recruited: patients with CRPS undergoing treatment at the Functional Independence Restoration Program (FIRST), patients with CRPS undergoing treatment at the Pain Management Center and matching healthy controls. Participants will undergo three sessions: the first session will be scheduled immediately before or as soon as possible at the beginning of the patients' treatment; the second session will take place at the end of the patients' treatment; the last session will be scheduled six months post-treatment. The timing of the sessions of the healthy participants will follow a schedule similar to the FIRST patients. Each session will last approximately three hours and include acquisition of psychosocial, psychophysical, and brain imaging data in the child participants, as well as acquisition of psychosocial data in the parent participants.
Detailed description
This is a basic science investigation of potential psychosocial, sensory, and brain markers predicting trajectory of short-term and long-term recovery in pediatric CRPS following both inpatient and outpatient treatment.
The usual inpatient treatment lasts on average three weeks and includes physical, occupational, and recreational therapy, as well as psychotherapy, while patients keep their regular pharmacological treatment. The usual outpatient treatment lasts on average several months and includes physical therapy and psychotherapy, in addition to pharmacotherapy. For both inpatients and outpatients, the primary anti-neuropathic pharmacotherapy typically includes gabapentin, pregabalin, or amitriptyline, or, less frequently, duloxetine. It is important to note that this study is not designed to investigate the efficacy of treatment per se, instead it aims to predict trajectory during the course of treatment as usual. This study is primarily mechanistic and does not include any intervention or modification of treatments. Therefore, patients, who are scheduled for regular inpatient or outpatient treatment of CRPS, are free to refuse to enroll without any consequences for the scheduled treatment.
The investigated markers will be assessed in patients undergoing inpatient or outpatient treatments. To define potentially relevant markers, measurements in patients will be compared to the same measurements in healthy children. For this purpose, participants will undergo a testing session just before the beginning of their treatment or as close as possible from the beginning of their treatment.
To establish the influence of potential markers on short-term recovery, patients will undergo an additional session upon completion of their treatment. To investigate the effect of the previously defined markers on long-term recovery, patients will complete a third session at six months after treatment. For comparison purposes, healthy control children will undergo sessions following the same schedule as the patients. To assess the association between symptoms of CRPS in children and social environment, at least one parent of each enrolled child will be asked to complete three sessions following the same schedule as their child.
Each testing session will include self-reported questionnaires for the children and their parents and a brain imaging session for the children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inpatients | – | Behavioral: observation and measure of trajectory of recovery in CRPSObservation and measure of trajectory of recovery in CRPS. This group will include children diagnosed with CRPS and undergoing regular therapy at the inpatient FIRST clinic at CCHMC and one of their parents or legal guardian. |
| Outpatients | – | Behavioral: observation and measure of trajectory of recovery in CRPSObservation and measure of trajectory of recovery in CRPS. This group will include children diagnosed with CRPS and undergoing regular therapy at the outpatient Pain Management Center at CCHMC and one of their parents or legal guardian. |
| Healthy Controls | – | Behavioral: observation and measure of trajectory of recovery in CRPSFor comparison purposes, healthy controls and one of their parents or legal guardian will be enrolled in this study as well. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants to this study may be part of one of the following groups: children diagnosed with CRPS undergoing inpatient treatment at the FIRST clinic (CCHMC), children diagnosed with CRPS underdoing outpatient treatment at the pain management clinic (CCHMC or comparable outpatient programs), or healthy children. The investigator's groups will be matched as well as possible for BMI, sex, and age. In addition, one parent will be recruited with each child.
Key inclusion criteria (15 listed)
- Age between 10 and 17 years old
- Fluent in English
- Diagnosis of CRPS
- Former unsuccessful treatment for CRPS
- Scheduled for or beginning the usual inpatient treatment for CRPS at the FIRST clinic at CCHMC.
Key exclusion criteria (8 listed)
- Weight/size incompatible with MRI scanner
- Identification of brain, neurologic, or severe psychiatric abnormalities beyond those normally associated with chronic pain.
- Documented developmental delays or impairment
- Any MRI contra-indication, including
- Braces, stents, clips, pace-maker or other metal implants affecting the safety of the participants in the scanner and/or the quality of the images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation and measure of trajectory of recovery in CRPSChild participants enrolled in this study will undergo three sessions, which will include psychosocial measures, brain imaging, and quantitative sensory testing. Parent participants will also complete three sessions, which only include psychosocial measures. | Behavioural | Healthy Controls, Inpatients, Outpatients |
Primary outcome
changes in pain perception
Time frame: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
changes in ratings of spontaneous pain intensity and unpleasantness assessed on non-numerical visual analog scales, ranging from 'no pain sensation'/'not at all unpleasant' to 'most intense pain sensation imaginable'/'most unpleasant imaginable'
Changes in functional disability
Time frame: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
Changes in scores on the self-reported Functional Disability Inventory investigates disabilities associated with pain which might impact on everyday functioning of children. It includes 15 questions assessing the children's capacity to perform everyday tasks, such as doing chores, walking, or eating regular meals. Participants evaluate their capacity to perform these tasks on Likert-type scale, ranging from "No Trouble" to "Impossible".
3 secondary outcomes
Changes in functional Magnetic Resonance Imaging (fMRI) BOLD (Blood Oxygenation Level Dependent) and pCASL (pseudo-Continuous Arterio-Spin Labeling) resting-state and task-related brain signal
Time frame: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
changes in fMRI BOLD and pCASL resting-state functional connectivity
Time frame: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
changes in DTI (Diffusion Tensor Imaging) structural connectivity
Time frame: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Robert C Coghill, PhD principal investigator
Children's Hospital, Cincinnati
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 Complex Regional Pain Syndromes, run by Children's Hospital Medical Center, Cincinnati 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 15 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Eve Hoeppli, PhD ((513)803-1164, marie-eve.hoeppli@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in pain perception (time frame: before treatment, at the end of the treatment (an average of 4 weeks for inpatients and 3 months for outpatients after session 1), and 6-month post treatment for patients; 1 month after session 1 and 6 months after session 2 for healthy participants). The study lists 2 primary outcomes in all. 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 7 Feb 2024.