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NCT Number: NCT05777889

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

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Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

Location status: Recruiting

Location contact

Alexandra Sideris, PhD

CONTACT

[email protected]

212-774-2602

Semih Gungor, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forward Looking InfraRed Camera

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Pa Thor, PhD

CONTACT

[email protected]

646-797-8535

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Acronym: SCS-FLIR

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2023
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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