Clinical trial NCT06337526: Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS)
Official title: Identifying Factors Associated With Acute Pain Exacerbation in Children With Complex Regional Pain Syndrome (CRPS): A Novel Research Plan
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Complex Regional Pain Syndromes
Keywords: Child
Pediatrics
Pain
Neuropathic
CRPS
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Medeloop.ai
First posted: 2024-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with CRPS diagnosed in a pediatric pain management clinic.

Brief summary: objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of...

Exclusion Criteria:

-

Primary outcomes:
measure: Change from baseline in pain score
timeFrame: Baseline through month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Pediatric Pain Clinic
state: California
Study officials:
affiliation: Stanford University
name: ANDREW DINH, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: ELLIOT KRANE, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.