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

Recruiting

• Conditions: CRPS (Complex Regional Pain Syndromes)
• Interventions: Other: Infrared Imaging

• Registration Number: NCT05852210
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Study Timeline

• Study First Submitted: 2023-03-09
• Study Start: 2023-04-01
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infrared CRPS Group	Infrared Imaging	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.

Primary Outcome Measures

Name	Time	Method
Complex regional pain syndrome Severity Score (CSS)	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.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	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."

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States