CSS-SR Validation Study

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT06798493
Status
Enrolling By Invitation

Conditions

  • Complex Regional Pain Syndrome
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Complex Regional Pain Syndrome (CRPS) Severity Score - Self Report — OTHER
    Self-report tool in a questionnaire format to capture CPRS Severity Score.

Study Details

Complex Regional Pain Syndrome (CRPS) is an orphan condition with no interventions proven effective in large-scale clinical trials. In-person clinical evaluations are required to make a CRPS diagnosis and determine study eligibility, making recruitment for CRPS trials challenging. To address this barrier, we will validate a self-report measure of CRPS symptom severity suitable for remote administration that was created by colleagues at Vanderbilt University. The aim of this study is to evaluate the correspondence at the item and total score level between the proposed self-report measure (CRPS Severity Score-Self Report; CSS-SR) and an existing validated measure of CRPS signs and symptoms derived from clinical history and physical examination data (CSS-Clinician version) and evaluate its diagnostic accuracy relative to clinically determined, criterion-based CRPS diagnosis using the Budapest criteria.

Key Dates

Start date
Jan 27, 2025
Status verified
Jan 2026
Primary completion
Dec 29, 2026
Completion
Dec 29, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: CRPS group
    Patients suspected or diagnosed with unilateral CRPS type I or II of the upper or lower extremity
  • Arm: Non-CRPS group
    Patients suspected or diagnosed with non-CRPS-related pain of the upper or lower extremities

Primary Outcome Measure

Concordance between CSS-Clinician and CSS-SR total scores [ Time Frame: Date of enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021-

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By research site
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