- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852210
Forward Looking InfraRed Imaging and Severity Score in Complex Regional Pain Syndrome (FLIR)
The Correlation of Thermal FLIR Imaging and Severity Score in Patients With Newly Diagnosed CRPS
The goal of this interventional study is to explore the use of InfraRed (FLIR) imaging in determining pain intensity and severity in newly diagnosed complex regional pain syndrome patients. The main questions it aims to answer are:
Question 1: Can Infrared (FLIR) imaging be used to determine the severity of CRPS in newly diagnosed patients? Question 2: Is there any correlation with the quantification of 'the Δ thermal index value' measured by FLIR imaging with pain intensity (NRS) in newly diagnosed patients? Question 3: Is there any correlation between the quantification of 'the Δheat index value' measured by FLIR imaging between the two extremities with the severity (the severity score for CRPS) in newly diagnosed patients? Participants will have a picture of their foot taken using the forward looking infrared (FLIR) camera and answer questionnaires regarding their pain and complex regional pain syndrome (CRPS).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with CRPS have a better chance of remission if they receive treatment early in the disease's progression. Similarly, determining the severity of the disease early on is critical for planning effective treatment to prevent progression. The lack of an objective method for determining the severity and potential progression of CRPS is a major reason for postponing CRPS treatment.
The purpose of this interventional study is to investigate whether or not near-infrared (FLIR) imaging can be used to evaluate the level of pain experienced by patients who have recently been diagnosed with complex regional pain syndrome. Its primary goals are to provide responses to the following questions:
Question 1: Can Infrared (FLIR) imaging be used to determine the severity of CRPS in newly diagnosed patients? Question 2: Is there any correlation with the quantification of 'the Δ thermal index value' measured by FLIR imaging with pain intensity (NRS) in newly diagnosed patients? Question 3: Is there any correlation between the quantification of 'the Δheat index value' measured by FLIR imaging between the two extremities with the severity (the severity score for CRPS) in newly diagnosed patients? The forward looking infrared (FLIR) camera will be used to take a picture of each participant's foot, and they will also be asked to fill out questionnaires regarding their level of pain and complex regional pain syndrome (CRPS).
If infrared (FLIR) imaging can be used to determine the severity of CRPS in newly diagnosed patients, and if there is a correlation between the quantification of the heat index value' measured by FLIR imaging and the severity score for CRPS in newly diagnosed patients, the findings of this study could be useful in daily clinical practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Justas Lauzadis, PhD
- Phone Number: 212-774-2946
- Email: lauzadisj@hss.edu
Study Contact Backup
- Name: Burcu Candan, MD
- Phone Number: 332-265-6644
- Email: candanb@hss.edu
Study Locations
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New York
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New York, New York, United States, 10021
- Recruiting
- Hospital for Special Surgery
-
Contact:
- Justas Lauzadis, PhD
- Phone Number: 212-774-2946
- Email: lauzadisj@hss.edu
-
Contact:
- Burcu Candan, MD
- Phone Number: 332-265-6644
- Email: candanb@hss.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patient is between 18 and 85 years old
- Providing CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria.
- The patients affected with CRPS in a unilateral limb
- The patient has had pain and other symptoms for more than 3 months
Exclusion Criteria:
- Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT).
- Systemic or local infection
- Malignancy
- Pregnancy
- Uncontrollable medical and psychiatric condition
- The patients diagnosed with dysautonomia, sympathetic dysfunction(such as Raynaud disease or Buerger disease), and patients on vasoactive drugs, the mechanism of action is directly on the vasculartone.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infrared CRPS Group
This group includes people who have recently been diagnosed with CRPS type 1. Participants in the Infrared group will have their feet photographed using a:
|
This study will use thermal forward looking infrared (FLIR) imaging to assess the severity of Complex Regional Pain Syndrome in newly diagnosed patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complex regional pain syndrome Severity Score (CSS)
Time Frame: At pre-surgical screening
|
The CRPS Severity Score (CSS) is a validated continuous score to measure CRPS severity.
It conforms to the Budapest CRPS criteria and tracks symptoms over time.
It includes 17 signs and symptoms (8 reported by the patient and 9 observed on the day of the examination).
The CSS score (range 0-17) is calculated by adding reported and observed symptoms, with a higher score (17) indicating a greater number of symptoms.
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At pre-surgical screening
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS)
Time Frame: At pre-surgical screening
|
The numeric rating scale (NRS) is a pain screening tool that uses a 0-10 scale to assess pain severity at that time, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
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At pre-surgical screening
|
Collaborators and Investigators
Investigators
- Principal Investigator: Semih Gungor, MD, Hospital for Special Surgery, New York
Publications and helpful links
General Publications
- Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002 May 11;359(9318):1655-60. doi: 10.1016/S0140-6736(02)08589-6.
- Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Schlereth T, Chont M, Vatine JJ. Development of a severity score for CRPS. Pain. 2010 Dec;151(3):870-876. doi: 10.1016/j.pain.2010.09.031. Epub 2010 Oct 20.
- Bruehl S, Lubenow TR, Nath H, Ivankovich O. Validation of thermography in the diagnosis of reflex sympathetic dystrophy. Clin J Pain. 1996 Dec;12(4):316-25. doi: 10.1097/00002508-199612000-00011.
- Jeon SG, Choi EJ, Lee PB, Lee YJ, Kim MS, Seo JH, Nahm FS. Do severity score and skin temperature asymmetry correlate with the subjective pain score in the patients with complex regional pain syndrome? Korean J Pain. 2014 Oct;27(4):339-44. doi: 10.3344/kjp.2014.27.4.339. Epub 2014 Oct 1.
- Krumova EK, Frettloh J, Klauenberg S, Richter H, Wasner G, Maier C. Long-term skin temperature measurements - a practical diagnostic tool in complex regional pain syndrome. Pain. 2008 Nov 15;140(1):8-22. doi: 10.1016/j.pain.2008.07.003. Epub 2008 Aug 23.
- Wasner G, Schattschneider J, Baron R. Skin temperature side differences--a diagnostic tool for CRPS? Pain. 2002 Jul;98(1-2):19-26. doi: 10.1016/s0304-3959(01)00470-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-2175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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