Recruiting

Spinal Cord Stimulation

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT05777889

Conditions

Complex Regional Pain Syndromes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Forward Looking InfraRed Camera

Study Details

Brief 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.

Conditions

Complex Regional Pain Syndromes

Study ID

NCT05777889

Start date

Feb 22, 2023

Status verified date

Oct, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Pa Thor, PhD

646-797-8535thorp@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Alexandra Sideris, PhD

212-774-2602siderisa@hss.edu

Principal Investigator:

Semih Gungor, MD

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Nov 26, 2025

Last verified

Oct, 2025

Keywords

  • spinal
  • infrared

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2025-11-26.