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

NCT06337526 | Not Yet Recruiting

• 1 other identifier: IRB-71503
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complex Regional Pain Syndromes

Keywords

Child; Pediatrics; Pain; Neuropathic; CRPS

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pain score

  Pain assessed on an 11-point Likert Scale (score range: 0 to 10)

  Baseline through month 6

Study Arms (1)

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.

Device: Apple Watch v8

Interventions

Apple Watch v8 DEVICE

Apple Watch used for data collection only

Children & Adolescents with Active CRPS

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with CRPS diagnosed in a pediatric pain management clinic.

You may qualify if:

• Clinical diagnosis of...

Sponsors & Collaborators

• Stanford University: lead
• Medeloop.ai: collaborator

Study Sites (1)

Pediatric Pain Clinic

Stanford, California, 94305, United States

Location

Related 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.

  PMID: 27005945 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.

  PMID: 35687369 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.

  PMID: 19590474 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.

  PMID: 20194147 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ANDREW DINH, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• ELLIOT KRANE, MD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

ANDREW DINH, MD

CONTACT

650 - 736 - 3555; ATDINH@STANFORD.EDU

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus, Dept of Anesthesiology

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)