RecruitingNCT05777889

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

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

Sponsor

Hospital for Special Surgery, New York

Enrollment

12 participants

Start Date

Feb 22, 2023

Study Type

OBSERVATIONAL

Conditions

Complex Regional Pain Syndromes

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), 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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

The patient is between 18 and 85 years old
Providing CRPS diagnostic criteria by using the Budapest Clinical Diagnostic Criteria.
CRPS affecting unilateral lower extremity
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 Criteria8

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

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Interventions

OTHERForward Looking InfraRed Camera

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.