CSS-SR Validation Study

NCT06798493 | Enrolling By Invitation

• 1 other identifier: 2024-1529
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Complex Regional Pain Syndrome

Keywords

CRPS; Complex Regional Pain Syndrome; self-report; Complex Regional Pain Syndrome Severity Score (CSS)

Outcome Measures

Primary Outcomes (1)

• Concordance between CSS-Clinician and CSS-SR total scores

  Concordance between CSS-Clinician total scores, which will be on a numerical scale potentially ranging from 0-16, and CSS-SR total scores, which will be on a numerical scale potentially ranging from 0-13. Higher scores indicate greater CRPS symptom severity while lower scores indicate a lesser degree of symptom severity. Concordance (corrected for chance agreement) between CSS-Clinician and CSS-SR items and total scores will be assessed using intraclass correlations (ICCs; two-way random effects model; potential range = -1.00 to 1.00). Strength of agreement will be evaluated for descriptive purposes based on published recommendations: \< 0.50 = poor agreement, 0.50 - 0.75 = moderate agreement, 0.76 - 0.90 = good agreement, and \>0.90 = excellent agreement. All analyses will use the maximum number of cases available with a two-sided p\<0.05 criterion for statistical significance.

  Date of enrollment

Secondary Outcomes (1)

• Diagnostic accuracy relative to clinically-determined, criterion-based CRPS diagnosis using the Budapest criteria

  Date of enrollment

Study Arms (2)

CRPS group

Patients suspected or diagnosed with unilateral CRPS type I or II of the upper or lower extremity

Other: Complex Regional Pain Syndrome (CRPS) Severity Score - Self Report

Non-CRPS group

Patients suspected or diagnosed with non-CRPS-related pain of the upper or lower extremities

Other: Complex Regional Pain Syndrome (CRPS) Severity Score - Self Report

Interventions

Complex Regional Pain Syndrome (CRPS) Severity Score - Self Report OTHER

Self-report tool in a questionnaire format to capture CPRS Severity Score.

CRPS group; Non-CRPS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital for Special Surgery Outpatient Pain Management Patients

You may qualify if:

• years of age or older
• Suspected or diagnosed with unilateral CRPS type I or II of the upper or lower extremity
• Suspected or diagnosed with non-CRPS-related pain of the upper or lower extremities

You may not qualify if:

• Bilateral CRPS
• Total knee arthroplasty as the inciting event of CRPS
• Less than 18 years of age
• Non-English speaking
• Inability to comprehend study protocol and questionnaires

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Vanderbilt University: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (3)

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.

  PMID: 21285161 BACKGROUND

• Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.

  PMID: 24787228 BACKGROUND

• Bruehl S. An update on the pathophysiology of complex regional pain syndrome. Anesthesiology. 2010 Sep;113(3):713-25. doi: 10.1097/ALN.0b013e3181e3db38.

  PMID: 20693883 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

• Alexandra Sideris, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 29, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

US (1)