Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT06798493
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-30
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSS-SR Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance between CSS-Clinician and CSS-SR total scores', 'timeFrame': 'Date of enrollment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy relative to clinically-determined, criterion-based CRPS diagnosis using the Budapest criteria', 'timeFrame': 'Date of enrollment', 'description': 'Rates of CRPS diagnoses on both the CSS-Clinician and CSS-SR will be summarized as frequencies of positive and negative diagnoses.\n\nCut scores on the CSS-SR for use in determining its accuracy as a screening tool for predicting dichotomous criterion-based CRPS diagnosis will be generated by inspection of receiver operating characteristic (ROC) curves and associated sensitivity/specificity values. All analyses will use the maximum number of cases available with a two-sided p\\<0.05 criterion for statistical significance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CRPS', 'Complex Regional Pain Syndrome', 'self-report', 'Complex Regional Pain Syndrome Severity Score (CSS)'], 'conditions': ['Complex Regional Pain Syndrome', 'Pain']}, 'referencesModule': {'references': [{'pmid': '21285161', 'type': 'BACKGROUND', 'citation': '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': '24787228', 'type': 'BACKGROUND', 'citation': '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': '20693883', 'type': 'BACKGROUND', 'citation': 'Bruehl S. An update on the pathophysiology of complex regional pain syndrome. Anesthesiology. 2010 Sep;113(3):713-25. doi: 10.1097/ALN.0b013e3181e3db38.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nCRPS 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.\n\nOur 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.\n\nThe 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.\n\nScoring 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital for Special Surgery Outpatient Pain Management Patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Suspected or diagnosed with unilateral CRPS type I or II of the upper or lower extremity\n* Suspected or diagnosed with non-CRPS-related pain of the upper or lower extremities\n\nExclusion Criteria:\n\n* Bilateral CRPS\n* Total knee arthroplasty as the inciting event of CRPS\n* Less than 18 years of age\n* Non-English speaking\n* Inability to comprehend study protocol and questionnaires'}, 'identificationModule': {'nctId': 'NCT06798493', 'briefTitle': 'CSS-SR Validation Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Validation of the CRPS Severity Score-Self Report', 'orgStudyIdInfo': {'id': '2024-1529'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRPS group', 'description': 'Patients suspected or diagnosed with unilateral CRPS type I or II of the upper or lower extremity', 'interventionNames': ['Other: Complex Regional Pain Syndrome (CRPS) Severity Score - Self Report']}, {'label': 'Non-CRPS group', 'description': 'Patients suspected or diagnosed with non-CRPS-related pain of the upper or lower extremities', 'interventionNames': ['Other: Complex Regional Pain Syndrome (CRPS) Severity Score - Self Report']}], 'interventions': [{'name': 'Complex Regional Pain Syndrome (CRPS) Severity Score - Self Report', 'type': 'OTHER', 'description': 'Self-report tool in a questionnaire format to capture CPRS Severity Score.', 'armGroupLabels': ['CRPS group', 'Non-CRPS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Alexandra Sideris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data sharing plan will be finalized with our collaborators at study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}