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

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT05777889
Status
Recruiting
Apply to this trial

Conditions

  • Complex Regional Pain Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Forward Looking InfraRed Camera — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 22, 2023
Status verified
Oct 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: 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, and neuropathic pain.

Primary Outcome Measure

Temperature difference in limb [ Time Frame: 2-8 days after the trial procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Alexandra Sideris, PhD
[email protected]
212-774-2602
Semih Gungor, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Hospital for Special Surgery· New York, NY

Related Studies