An observational study in Complex Regional Pain Syndromes, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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Among 88 studies in Complex Regional Pain Syndromes with a site in United States — 20 open to participants now, 22 under way, 2 of them phase 3. Complex Regional Pain Syndromes · United States.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, this one is the 6th largest by planned enrollment of the 21 observational ones that give a count, is one of 10 that started in 2018, is one of 21 observational ones, reaches primary completion later than 5 of the 21 other live ones, and was the 52nd registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
Browse Complex Regional Pain Syndromes studies →20 of the 88 studies in Complex Regional Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Scripps Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 10 Years to 17 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10 · Phase 3 13 · Phase 4 4
First in 2000; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 126 is above the median of 58 across 44 observational studies indexed under Complex Regional Pain Syndromes.
Median enrollment 30 across the 67 interventional studies, 60 across the 21 observational. Of the 56 that completed or were terminated, 29 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 88 have an industry lead sponsor. The 10 most frequent:
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 129 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Children's Hospital Medical Center, Cincinnati has 3 studies filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
8 of the studies in Complex Regional Pain Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06798493Hospital for Special Surgery, New YorkCSS-SR Validation Study | 2026-12-29 |
| NCT05593237University of California, San FranciscoTranscranial Magnetic Stimulation for Chronic Neuropathic Pain | 2026-12-30 |
| NCT05477004Theresa LiiObservational Study of Ketamine Infusions for the Treatment of Chronic Pain | 2026-12-31 |
| NCT05777889Hospital for Special Surgery, New YorkInfrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients | 2027-02 |
| NCT05814497Children's Hospital Medical Center, CincinnatiSupraspinal Processing of Sensory Aspects of Pain | 2027-06-30 |
Add all 8 to your calendar (.ics) → With an account.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Children:
Inpatients:
Outpatients:
Healthy children:
Parents:
Exclusion Criteria:
All child participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: observation and measure of trajectory of recovery in CRPS
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.
Behavioral: observation and measure of trajectory of recovery in CRPS
For comparison purposes, healthy controls and one of their parents or legal guardian will be enrolled in this study as well.
Behavioral: observation and measure of trajectory of recovery in CRPS
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.
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'
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 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".
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 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
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
fMRI BOLD and pCASL will be used measure of changes in functional connectivity at rest
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
Diffusion tensor imaging will be used to measure changes in 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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Aug 2018 (actual). Primary completion is estimated for Aug 2026, 96 months after the start.
Of 18 observational studies under Complex Regional Pain Syndromes, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 147. This study's planned 96 months is above that.
How these figures are worked out, and which studies are left out of them.
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Complex Regional Pain Syndromes →
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