Forward Looking InfraRed Imaging and Severity Score in Complex Regional Pain Syndrome
NCT ID: NCT05852210
Last Updated: 2025-11-12
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
30 participants
OBSERVATIONAL
2023-04-01
2025-12-01
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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:
* FLIR T420 or T62101 camera with 320\*240 resolution.
* Each image will be captured at a perpendicular angle with a 1-inch gap on all four sides.
* The patients' feet will be separated from the background using a Myler blanket.
* The camera will be normalized to the temperate range of 15°C minimum and 40°C maximum.
* Patients will complete questionnaires about the severity of their CRPS and their pain levels.
Infrared Imaging
This study will use thermal forward looking infrared (FLIR) imaging to assess the severity of Complex Regional Pain Syndrome in newly diagnosed patients.
Interventions
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Infrared Imaging
This study will use thermal forward looking infrared (FLIR) imaging to assess the severity of Complex Regional Pain Syndrome in newly diagnosed patients.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Semih Gungor, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022-2175
Identifier Type: -
Identifier Source: org_study_id
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