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| Name | Class |
|---|---|
| Medeloop.ai | UNKNOWN |
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objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS.
Hypothesis(es) and Aims: Investigators hypothesize that spontaneous exacerbations ("flares") of limb pain caused by CRPS have identifiable and predictable precipitants and timing. The aim of this trial is (1) to aggregate large databases of real-time physiological, psychological, subjective pain, environmental and dietary data and analyze these data with artificial intelligence (AI) to identify temporal precipitants to pain exacerbations, and (2) to identify potential strategies to interrupt the progression of acute pain flares based upon what is learned. Early treatment and strategies to interrupt acute pain flares would have a significant effect on quality of life in this patient population while undergoing treatment and resolution of the ongoing condition.
Design: Design of the study: prospective observational study. Subjects: will be recruited from Stanford's pediatric pain clinic and other like centers nation-wide. Subjects will be issued an Apple Watch and the Medeloop app for data collection. Data collection: Medeloop will collect subjects' electronic medical records (existing and prospective) if subjects sign into the hospital's patient portal through Medeloop.
The Apple Watch will transmit physiologic data to Medeloop in real time for a period of 6 months to derive physiologic parameters from Apple Watch measured pulse rate, oxygen saturation, time in daylight, ECG measurement, and movement/activity. Derived variables include heart rate variability, sleep hours, daily distance walked, right/left weight bearing and gait and others. Using a paired smartphone, subjects will photograph all meals for analysis of the dietary content by AI, which will be transmitted to Medeloop after capture for AI analysis. Medeloop software will use location data and cross-reference corresponding environmental and weather data (e.g., atmospheric conditions, air and water quality) on a daily basis. All pain flares will be recorded in real time via the Medeloop app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children & Adolescents with Active CRPS | Subjects between the ages of 10 and 18 years, who have CRPS diagnosed in a pediatric pain center or clinic and whose CRPS is presently active (i.e. unresolved), of either gender, and any ethnicity or racial group. For 6 months subjects will wear an Apple Watch, transmitting physiologic and movement data to the investigators, will photograph their meals for AI analysis of content, and log their pain scores and episodes of pain flares, and independently the investigators will collect weather and environmental data in the subject's location. These data will be analyzed by AI to identify chronologic triggers of pain flares. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Watch v8 | Device | Apple Watch used for data collection only |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain score | Pain assessed on an 11-point Likert Scale (score range: 0 to 10) | Baseline through month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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Children and adolescents with CRPS diagnosed in a pediatric pain management clinic.
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| Name | Affiliation | Role |
|---|---|---|
| ANDREW DINH, MD | Stanford University | Principal Investigator |
| ELLIOT KRANE, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Pain Clinic | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27005945 | Background | Abu-Arafeh H, Abu-Arafeh I. Complex regional pain syndrome in children: incidence and clinical characteristics. Arch Dis Child. 2016 Aug;101(8):719-23. doi: 10.1136/archdischild-2015-310233. Epub 2016 Mar 22. | |
| 35687369 | Background | Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2025 | May 12, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| 19590474 | Background | Schwartzman RJ, Erwin KL, Alexander GM. The natural history of complex regional pain syndrome. Clin J Pain. 2009 May;25(4):273-80. doi: 10.1097/AJP.0b013e31818ecea5. |
| 20194147 | Background | Walco GA, Dworkin RH, Krane EJ, LeBel AA, Treede RD. Neuropathic pain in children: Special considerations. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S33-41. doi: 10.4065/mcp.2009.0647. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |