CSS-SR Validation Study (NCT06798493) | Clinical Trial Compass
By InvitationNot Applicable
CSS-SR Validation Study
United States100 participantsStarted 2025-01-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concordance between CSS-Clinician and CSS-SR total scores