Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Recruiting

CT.gov ID

NCT05777889

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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), Quality of Life (SF-36), 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, quality of life, and neuropathic pain.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndromes	Other: Forward Looking InfraRed Camera

Detailed Description

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?

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, quality of life, and neuropathic pain.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Effect of Spinal Cord Stimulation on Thermal Forward Looking InfraRed (FLIR) Imaging in Complex Regional Pain Syndrome (CRPS)

Actual Study Start Date :

Feb 22, 2023

Anticipated Primary Completion Date :

Feb 22, 2024

Anticipated Study Completion Date :

Feb 22, 2025

Arms and Interventions

Arm	Intervention/Treatment
Study CRPS Group Enrolled patients with complex regional pain syndrome undergoing a surgical procedure that requires spinal cord stimulation. All participants in the group 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. All participants will also answer questionnaires about: their average pain score, CRPS severity, quality of life, and neuropathic pain.	Other: Forward Looking InfraRed Camera Forward Looking InfraRed Camera: We will use a FLIR T420 or T62101 camera with a resolution of 320*240. Each image will be captured perpendicularly with a 1-inch gap on all four sides. A Myler blanket placed in the background will separate the feet from the background. The camera will be normalized to a temperature range of 15°C to 40°C. The images will be saved in radiometric JPEG format. Once the images have been transferred to a computer, we will remove the background. Next, we'll make a temperature histogram with 0.1°C temperature bin resolution. The before and after histograms (IB, IA) will be compared to see which one indicates more extreme temperature distributions. Those who improve by 30% or more are considered to have had a successful spinal cord stimulation.

Arm

Intervention/Treatment

Study CRPS Group

Enrolled patients with complex regional pain syndrome undergoing a surgical procedure that requires spinal cord stimulation. All participants in the group 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. All participants will also answer questionnaires about: their average pain score, CRPS severity, quality of life, and neuropathic pain.

Other: Forward Looking InfraRed Camera

Forward Looking InfraRed Camera: We will use a FLIR T420 or T62101 camera with a resolution of 320*240. Each image will be captured perpendicularly with a 1-inch gap on all four sides. A Myler blanket placed in the background will separate the feet from the background. The camera will be normalized to a temperature range of 15°C to 40°C. The images will be saved in radiometric JPEG format. Once the images have been transferred to a computer, we will remove the background. Next, we'll make a temperature histogram with 0.1°C temperature bin resolution. The before and after histograms (IB, IA) will be compared to see which one indicates more extreme temperature distributions. Those who improve by 30% or more are considered to have had a successful spinal cord stimulation.

Outcome Measures

Primary Outcome Measures

Temperature difference in limb [at 48 hours after spinal cord stimulation]
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 at a 48 hours after spinal cord stimulation will mean there was improvement.

Secondary Outcome Measures

Average Numerical Rating Scale (NRS) Pain [at post-operative day, at 48 hours after surgery, and 1-2 weeks after surgery]
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.
Complex Regional Pain Syndrome Severity Score (CSS) [at intra-operative (during surgery) and at 1-2 weeks after surgery]
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 (1-2 weeks) 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.
Health Related Quality of Life (HRQoL) [at intra-operative (during surgery) and at 1-2 weeks after surgery]
The Health-Related Quality of Life (HRQOL-14) scale has 14 items that give a complete overview of a person's health and wellbeing. The four HRQOL questions measure: (1) self-perceived health (excellent, very good, good, fair, or poor), (2) number of days out of the past 30 that physical health was not good, (3) number of days out of the past 30 that mental health was not good, and (4) number of days out of the past 30 that usual activities were limited by poor physical or mental health. Follow by ten additional questions about health-related quality of life. A quantitative measure on delta thermal camera value that shows a difference of 50% or higher in correlation to HRQoL values (the delta pain QoL value). The developed quantitative measurement will be compared with the currently used HRQoL values at postoperative follow-up (1-2 weeks) timepoints after completion of the SCS.
Neuropathic Pain Score (PainDetect-PD) [At Post-operative Day 1 and 1-2 weeks after surgery]
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 (1-2 weeks) time points after completion of the SCS.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient is between 18 and 85 years old
Providing CRPS diagnostic criteria by using the Budapest Clinical Diagnostic Criteria.
The patient has had pain and other symptoms for more than 3 months
Not responding to conventional medical treatments and multidisciplinary approach
High NRS detection in pain assessment despite appropriate treatment (NRS= and > 6/10).
Pain causing a limitation in the patient's functional capacity despite appropriate treatment.

Exclusion Criteria:

Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT).
Systemic or local infection
Coagulation disorders
History of allergy to contrast material
Malignancy
Pregnancy
Uncontrollable medical and psychiatric condition
The patients diagnosed with dysautonomia, sympathetic dysfunction other than CRPS (such as Raynaud disease or Buerger disease), sweating disorders other than CRPS (such as acquired idiopathic generalized anhidrosis), and patients