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CRPS (Complex Regional Pain Syndromes)FLIRNCT05852210

Forward Looking InfraRed Imaging and Severity Score in Complex Regional Pain Syndrome

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this interventional study is to explore the use of InfraRed (FLIR) imaging in determining pain intensity and severity in newly diagnosed complex regional pain syndrome patients. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
CRPS (Complex Regional Pain Syndromes)
What is being tested?
Infrared Imaging
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Apr 2023to 1 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

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 being treated at the Hospital for Special Surgery for CRPS in a unilateral limb.

Who may be able to join

  • The patient is between 18 and 85 years old
  • Providing CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria.
  • The patients affected with CRPS in a unilateral limb
  • The patient has had pain and other symptoms for more than 3 months

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
  • Malignancy
  • Pregnancy
  • Uncontrollable medical and psychiatric condition
  • The patients diagnosed with dysautonomia, sympathetic dysfunction(such as Raynaud disease or Buerger disease), and patients on vasoactive drugs, the mechanism of action is directly on the vasculartone.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

Official title: The Correlation of Thermal FLIR Imaging and Severity Score in Patients With Newly Diagnosed CRPS

The goal of this interventional study is to explore the use of InfraRed (FLIR) imaging in determining pain intensity and severity in newly diagnosed complex regional pain syndrome patients. The main questions it aims to answer are:

Question 1: Can Infrared (FLIR) imaging be used to determine the severity of CRPS in newly diagnosed patients? Question 2: Is there any correlation with the quantification of 'the Δ thermal index value' measured by FLIR imaging with pain intensity (NRS) in newly diagnosed patients? Question 3: Is there any correlation between the quantification of 'the Δheat index value' measured by FLIR imaging between the two extremities with the severity (the severity score for CRPS) in newly diagnosed patients? Participants will have a picture of their foot taken using the forward looking infrared (FLIR) camera and answer questionnaires regarding their pain and complex regional pain syndrome (CRPS).

Read the detailed description

Patients with CRPS have a better chance of remission if they receive treatment early in the disease's progression. Similarly, determining the severity of the disease early on is critical for planning effective treatment to prevent progression. The lack of an objective method for determining the severity and potential progression of CRPS is a major reason for postponing CRPS treatment.

The purpose of this interventional study is to investigate whether or not near-infrared (FLIR) imaging can be used to evaluate the level of pain experienced by patients who have recently been diagnosed with complex regional pain syndrome. Its primary goals are to provide responses to the following questions:

Question 1: Can Infrared (FLIR) imaging be used to determine the severity of CRPS in newly diagnosed patients? Question 2: Is there any correlation with the quantification of 'the Δ thermal index value' measured by FLIR imaging with pain intensity (NRS) in newly diagnosed patients? Question 3: Is there any correlation between the quantification of 'the Δheat index value' measured by FLIR imaging between the two extremities with the severity (the severity score for CRPS) in newly diagnosed patients? The forward looking infrared (FLIR) camera will be used to take a picture of each participant's foot, and they will also be asked to fill out questionnaires regarding their level of pain and complex regional pain syndrome (CRPS).

If infrared (FLIR) imaging can be used to determine the severity of CRPS in newly diagnosed patients, and if there is a correlation between the quantification of the heat index value' measured by FLIR imaging and the severity score for CRPS in newly diagnosed patients, the findings of this study could be useful in daily clinical practice.

Being tested
Infrared Imaging
Keywords
Infrared, CRPS
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.

  • Infrared ImagingOther

    This study will use thermal forward looking infrared (FLIR) imaging to assess the severity of Complex Regional Pain Syndrome in newly diagnosed patients.

Study groups in NCT05852210
Study groupRoleWhat they receive
Infrared CRPS GroupThis group includes people who have recently been diagnosed with CRPS type 1. Participants in the Infrared group will have their feet photographed using a: * FLIR T420 or T62101 camera with 320*240 resolution. * Each image will be captured at a perpendicular angle with a 1-inch gap on all four sides. * The patients' feet will be separated from the background using a Myler blanket. * The camera will be normalized to the temperate range of 15°C minimum and 40°C maximum. * Patients will complete questionnaires about the severity of their CRPS and their pain levels.
Receives: Other: Infrared Imaging

What is being measured

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

  1. Complex regional pain syndrome Severity Score (CSS)

    The CRPS Severity Score (CSS) is a validated continuous score to measure CRPS severity. It conforms to the Budapest CRPS criteria and tracks symptoms over time. It includes 17 signs and symptoms (8 reported by the patient and 9 observed on the day of the examination). The CSS score (range 0-17) is calculated by adding reported and observed symptoms, with a higher score (17) indicating a greater number of symptoms.

    Measured: At pre-surgical screening

Secondary outcomes (1)

  1. Numerical Rating Scale (NRS)

    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."

    Measured: At pre-surgical screening

Timeline

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

  1. First posted10 May 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2026

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
Other
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852210
Sponsor's protocol ID
2022-2175
Acronym
FLIR
Status last verified
Jan 2025
First submitted
9 Mar 2023
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with researchers.

Publications

  • 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

  • Bruehl S, Lubenow TR, Nath H, Ivankovich O. Validation of thermography in the diagnosis of reflex sympathetic dystrophy. Clin J Pain. 1996 Dec;12(4):316-25. doi: 10.1097/00002508-199612000-00011.

    PubMed 8969877

  • Jeon SG, Choi EJ, Lee PB, Lee YJ, Kim MS, Seo JH, Nahm FS. Do severity score and skin temperature asymmetry correlate with the subjective pain score in the patients with complex regional pain syndrome? Korean J Pain. 2014 Oct;27(4):339-44. doi: 10.3344/kjp.2014.27.4.339. Epub 2014 Oct 1.

    PubMed 25317283

  • 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

  • Krumova EK, Frettloh J, Klauenberg S, Richter H, Wasner G, Maier C. Long-term skin temperature measurements - a practical diagnostic tool in complex regional pain syndrome. Pain. 2008 Nov 15;140(1):8-22. doi: 10.1016/j.pain.2008.07.003. Epub 2008 Aug 23.

    PubMed 18723287

  • Wasner G, Schattschneider J, Baron R. Skin temperature side differences--a diagnostic tool for CRPS? Pain. 2002 Jul;98(1-2):19-26. doi: 10.1016/s0304-3959(01)00470-5.

    PubMed 12098613

Questions about this trial

What is this clinical trial studying?

An observational study of CRPS (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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Apr 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complex regional pain syndrome Severity Score (CSS) (time frame: At pre-surgical screening). 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 NCT05852210, which also lists 6 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 8 Apr 2026.

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