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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorHospital for Special Surgery, New York

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients diagnosised with complex regional pain syndrome, undergoing a surgery that requires spinal cord stimulation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Forward Looking InfraRed Camera

    Other intervention

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Study CRPS Group1 intervention

Trial outcomes

Primary outcomes

1

Temperature 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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

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