The goal of this observational study is to compare thermal camera Forward Looking InfraRed (FLIR) images before and after spinal cord stimulation to evaluate the difference in sympathetic activity of the affected limb in patients with complex regional pain syndrome (CRPS). The main questions it aims to answer are: Question 1: Can Infrared (FLIR) imaging be used to monitor the sympatholytic activity caused by Spinal Cord Stimulation (SCS) in patients with CRPS? Question 2: Is there any correlation between the quantification of sympatholytic activity produced by Spinal Cord Stimulation (SCS) and measured by FLIR imaging with the outcome measures in patients with CRPS? Outcome measures include pain (NRS), CRPS Severity Score (CSS), and neuropathic pain score (painDETECT). Participants will have an image of their feet taken perpendicularly with a 1-inch space from all four sides using a FLIR T420 or T62101 camera with 320\*240 resolution. Participants will also complete questionnaires about the average pain, CRPS severity, and neuropathic pain.
Patients with CRPS often present with sympathetic dysfunction and peripheral vasomotor disturbances. Spinal Cord Stimulation (SCS) may have a sympatholytic effect with improved microcirculation and regional blood flow. This research proposal aims to investigate the potential use of Forward Looking Infrared (FLIR) imaging to monitor whether the sympatholytic effect is enhanced by using SCS in CRPS patients. The goal of this observational study is to compare thermal camera Forward Looking InfraRed (FLIR) images before and after spinal cord stimulation to evaluate the difference in sympathetic activity of the affected limb in patients with complex regional pain syndrome (CRPS). The main questions it aims to answer are: Question 1: Can Infrared (FLIR) imaging be used to monitor the sympatholytic activity caused by Spinal Cord Stimulation (SCS) in patients with CRPS? Question 2: Is there any correlation between the quantification of sympatholytic activity produced by Spinal Cord Stimulation (SCS) and measured by FLIR imaging with the outcome measures in patients with CRPS? Outcome measures include pain (NRS), CRPS Severity Score (CSS), and neuropathic pain score (painDETECT). Participants will have an image of their feet taken perpendicularly with a 1-inch space from all four sides using a FLIR T420 or T62101 camera with 320\*240 resolution. Participants will also complete questionnaires about the average pain, CRPS severity, and neuropathic pain.
Study Type
OBSERVATIONAL
Enrollment
12
Forward Looking InfraRed Camera: 1. We will use a FLIR T420 or T62101 camera with a resolution of 320\*240. 2. Each image will be captured perpendicularly with a 1-inch gap on all four sides. 3. A Myler blanket placed in the background will separate the feet from the background. 4. The camera will be normalized to a temperature range of 15°C to 40°C. 5. The images will be saved in radiometric JPEG format. 6. Once the images have been transferred to a computer, we will remove the background. 7. Next, we'll make a temperature histogram with 0.1°C temperature bin resolution. 8. The before and after histograms (IB, IA) will be compared to see which one indicates more extreme temperature distributions. 9. Those who improve by 30% or more are considered to have had a successful spinal cord stimulation.
Hospital for Special Surgery
New York, New York, United States
RECRUITINGTemperature difference in limb
The temperature of the limb will be measured using the forward-looking infrared camera. A 30% or more improvement in temperature difference in the affected limb 2-8 days after spinal cord stimulation will mean there was improvement.
Time frame: 2-8 days after the trial procedure
Average Numerical Rating Scale (NRS) Pain
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." Although measured at different time points, the average score for each participant is average and then summed across all participants.
Time frame: 2-8 days after the trial procedure
Complex Regional Pain Syndrome Severity Score (CSS)
A continuous score for CRPS severity. It includes 17 signs and symptoms (8 reported by the patient, 9 observed at examination date). A value of 50% or higher on the CSS value at postoperative follow-up (2-8 days) time point after surgery indicates success of the forward looking infrared camera. Although measured at different time points, the difference between the time points will be calculated and reported.
Time frame: 2-8 days after the trial procedure
Average level of Neuropathic Pain Score (PainDetect-PD)
Quantifies severity of neuropathic pain. Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable. Quantitative measures (delta thermal camera value) are expected to provide a 50% or higher correlation to PD values (delta pain PD value). (The developed quantitative measurement will be compared with the currently used PD values at postoperative follow-up (2-8 days) time points after completion of the SCS.)
Time frame: 2-8 days after the trial procedure
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