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Complex Regional Pain SyndromesSCS-FLIRNCT05777889

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

An observational study of Complex Regional Pain Syndromes, run by Hospital for Special Surgery, New York at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Complex Regional Pain Syndromes
What is being tested?
Forward Looking InfraRed Camera
How many people
12 participants
Where
1 siteUnited States
Study dates
22 Feb 2023to Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pa Thor, PhD contact

646-797-8535

thorp@hss.edu

United States1 site, 1 recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Alexandra Sideris, PhD, 212-774-2602, siderisa@hss.edu

    Semih Gungor, MD

    Recruiting

Other trials in United States

About this study

Official title: 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?

Read more

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.

Read the 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.

Being tested
Forward Looking InfraRed Camera
Keywords
spinal, infrared
Medical subject headings
Complex Regional Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Forward Looking InfraRed CameraOther

    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 groups in NCT05777889
Study groupRoleWhat they receive
Study CRPS GroupEnrolled 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.
Receives: Other: Forward Looking InfraRed Camera

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2-8 days after the trial procedure

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.)

    Measured: 2-8 days after the trial procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start22 Feb 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05777889
Sponsor's protocol ID
2022-2480
Acronym
SCS-FLIR
Status last verified
Oct 2025
First submitted
9 Mar 2023
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

Publications

  • Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.

    PubMed 35687369

  • Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002 May 11;359(9318):1655-60. doi: 10.1016/S0140-6736(02)08589-6.

    PubMed 12020526

  • Croom JE, Foreman RD, Chandler MJ, Barron KW. Cutaneous vasodilation during dorsal column stimulation is mediated by dorsal roots and CGRP. Am J Physiol. 1997 Feb;272(2 Pt 2):H950-7. doi: 10.1152/ajpheart.1997.272.2.H950.

    PubMed 9124459

  • Jacobs MJ, Jorning PJ, Joshi SR, Kitslaar PJ, Slaaf DW, Reneman RS. Epidural spinal cord electrical stimulation improves microvascular blood flow in severe limb ischemia. Ann Surg. 1988 Feb;207(2):179-83. doi: 10.1097/00000658-198802000-00011.

    PubMed 3257679

  • Linderoth B, Fedorcsak I, Meyerson BA. Peripheral vasodilatation after spinal cord stimulation: animal studies of putative effector mechanisms. Neurosurgery. 1991 Feb;28(2):187-95.

    PubMed 1671794

  • Huh BK, Park CH, Ranson M, Campbell GL, Ravanbakht J. Thermogram in spinal cord stimulation with complex regional pain syndrome and a review of the literature. Neuromodulation. 2010 Apr;13(2):114-6. doi: 10.1111/j.1525-1403.2009.00236.x. Epub 2009 Sep 3.

    PubMed 21992784

  • Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med. 2007 May-Jun;8(4):326-31. doi: 10.1111/j.1526-4637.2006.00169.x.

    PubMed 17610454

  • Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Schlereth T, Chont M, Vatine JJ. Development of a severity score for CRPS. Pain. 2010 Dec;151(3):870-876. doi: 10.1016/j.pain.2010.09.031. Epub 2010 Oct 20.

    PubMed 20965657

Questions about this trial

What is this clinical trial studying?

An observational study of Complex Regional Pain Syndromes, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pa Thor, PhD (646-797-8535, thorp@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temperature difference in limb (time frame: 2-8 days after the trial procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05777889, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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