Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS)

Complex Regional Pain Syndromes Clinical Trial

Official title:

Identifying Factors Associated With Acute Pain Exacerbation in Children With Complex Regional Pain Syndrome (CRPS): A Novel Research Plan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337526
• Other study ID #: IRB-71503
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: ANDREW DINH, MD
• Phone: 650 - 736 - 3555
• Email: ATDINH[@]STANFORD.EDU
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of... Exclusion Criteria: -

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Apple Watch v8
Apple Watch used for data collection only

Locations

Country	Name	City	State
United States	Pediatric Pain Clinic	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Medeloop.ai

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain score	Pain assessed on an 11-point Likert Scale (score range: 0 to 10)	Baseline through month 6