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Forward Looking InfraRed Imaging and Severity Score in Complex Regional Pain Syndrome

The Correlation of Thermal FLIR Imaging and Severity Score in Patients With Newly Diagnosed CRPS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05852210
Acronym
FLIR
Enrollment
30
Registered
2023-05-10
Start date
2023-04-01
Completion date
2026-03-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CRPS (Complex Regional Pain Syndromes)

Keywords

Infrared, CRPS

Brief summary

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).

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.

Interventions

This study will use thermal forward looking infrared (FLIR) imaging to assess the severity of Complex Regional Pain Syndrome in newly diagnosed patients.

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complex regional pain syndrome Severity Score (CSS)At pre-surgical screeningThe 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.

Secondary

MeasureTime frameDescription
Numerical Rating Scale (NRS)At pre-surgical screeningThe 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."

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSemih Gungor, MD

Hospital for Special Surgery, New York

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026