CSS-SR Validation Study

NCT ID: NCT06798493

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2026-12-29

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.

Detailed Description

Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by spontaneous pain, allodynia and hyperalgesia, edema, vasomotor and sudomotor changes, and motor and trophic changes. It usually begins regionally in a single limb after injury or surgery, and inflammatory, autonomic, and central mechanisms all appear to contribute to differing degrees. There are currently no treatments for CRPS proven effective in large scale clinical trials.

CRPS is considered an orphan condition by the U.S. Food and Drug Administration, and as such, acquiring adequate sample sizes for definitive clinical trials is challenging. One barrier to recruitment into CRPS research studies is the need to conduct in-person evaluations to screen for presence of current CRPS clinical features and determine CRPS diagnostic status. Unlike conditions such as chronic low back pain, which can be identified with high accuracy based on questions that can be administered remotely (i.e., pain intensity, location, frequency, and impact), diagnosing CRPS using the 2012 International Association for the Study of Pain (IASP) criteria (i.e., the Budapest criteria) requires that a history and physical examination be conducted. This situation is similar to that formerly encountered in fibromyalgia studies prior to publication of the modified American College of Rheumatology 2010 criteria (i.e., diagnosis was based on clinical tender point evaluation), a barrier ultimately overcome by publication of the validated 2010 self-report diagnostic screening criteria that could be administered remotely.

Our collaborators developed a self-report measure suitable for remote delivery to assess CRPS-related symptoms. They evaluated the diagnostic accuracy of a self-report version of the CRPS Severity Score (CSS-SR) and assessed its validity relative to the original CSS based on clinician evaluation (CSS-Clinician) in 112 patients undergoing total knee arthroplasty (TKA). In this study we will recruit patients with pain in an extremity at the outpatient chronic pain clinic at 75th street and will ask patients to complete the CSS-SR while the clinician evaluates the participant against the Budapest CRPS diagnosis criteria per usual care. Data (no identifiers) will be shared with our collaborator who will analyze and combine the findings from his TKA cohort with our outpatient chronic pain cohort to understand the external validity of the CSS-SR.

The proposed content of the self-report version of the CSS (CSS-SR) was rationally developed by creating lay language items designed to parallel the diagnostic symptoms assessed in the standardized clinician-obtained history that provides the basis for the symptom component of the CSS-Clinician. Thirteen questions in yes/no (presence/absence) checklist format assess presence of symptoms in the following areas: more prolonged or severe pain than expected, allodynia/hyperalgesia, skin temperature changes, skin color changes, edema, sweating changes, trophic changes (skin, hair, nails), tremor, dystonia, weakness, and range of motion limitations.

Scoring of the CSS-SR parallels scoring of the CSS-Clinician, with items coded as 1 for "Yes" and 0 for "No", with responses summed to create a total CSS-SR score potentially ranging from 0-13.

For the current validation study, CSS-SR items referred specifically to the "affected limb" to ensure that participants describe symptoms in the same body region as reflected in the assessment used to derive the CSS-Clinician.

Conditions

Complex Regional Pain Syndrome; Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

CRPS group

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

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

Intervention Type: OTHER

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

Non-CRPS group

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

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Sideris, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21285161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24787228 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 20693883 (View on PubMed)

Other Identifiers

2024-1529

Identifier Type: -

Identifier Source: org_study_id