Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients (SCS-FLIR)

November 19, 2025 updated by: Hospital for Special Surgery, New York

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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?

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 (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pa Thor, PhD
  • Phone Number: 646-797-8535
  • Email: thorp@hss.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital For Special Surgery
        • Contact:
        • Principal Investigator:
          • Semih Gungor, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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, and neuropathic pain.
Other: Forward 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature difference in limb
Time Frame: 2-8 days after the trial procedure
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.
2-8 days after the trial procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Numerical Rating Scale (NRS) Pain
Time Frame: 2-8 days after the trial procedure

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.
2-8 days after the trial procedure
Complex Regional Pain Syndrome Severity Score (CSS)
Time Frame: 2-8 days after the trial procedure

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.
2-8 days after the trial procedure
Average level of Neuropathic Pain Score (PainDetect-PD)
Time Frame: 2-8 days after the trial procedure

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.)
2-8 days after the trial procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Semih Gungor, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-2480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication

IPD Sharing Access Criteria

For researchers who provide a methodologically sound proposal and analyses to achieve aims in the approved proposal. Proposals should be directed to siderisa@hss.edu. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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