ClinicalTrials.gg
CompletedNCT05693337Updated Dec 27, 2024

Infrared Imaging in Complex Regional Pain Syndrome

An observational study in Complex Regional Pain Syndromes, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Hospital for Special Surgery, New York · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 88 studies in Complex Regional Pain Syndromes with a site in United States — 20 open to participants now, 22 under way, 2 of them phase 3. Complex Regional Pain Syndromes · United States.

Enrollment
14th of 21
30 · median 60
Started
2023
with 6 others
Observational
21 of 88
6 open now
Registered
68th of 88
by date
Lead sponsor
6 of 88
Hospital for Special Surgery, New York

Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, this one is the 14th largest by enrollment of the 21 observational ones that give a count, is one of 7 that started in 2023, is one of 21 observational ones, and was the 68th registered.

Complex Regional Pain Syndromes

206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.

Browse Complex Regional Pain Syndromes studies →

Open to participants now

20 of the 88 studies in Complex Regional Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:

15 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 88 studies in Complex Regional Pain Syndromes with a site in United States, or all of them as a file.
02

Study summary

This research proposal aims to investigate the potential use of Infrared (FLIR) imaging to monitor the successful achievement of the sympathetic blockade in patients with complex regional pain syndrome (CRPS).

Read the detailed description

Sympathetic blocks are clinically used to diagnose and treat sympathetically mediated pain. Despite the frequent use of these blocks, there remains a need for an objective method to determine the achievement of a sympathetic block in the clinical setting.

Current clinical practice assess the success of a sympathetic block by observation of clinical signs of sympathetic blockade. These signs include monitoring skin temperature, pulse amplitude, blood oxygen, or any combination of these methods. However, clinical signs of sympathetic blockade often demonstrate an unpredictable or delayed response and can make monitoring difficult.

Therefore, it is necessary to develop an objective monitoring method that is reliable, rapid response, and not affected by the other confounders. One potential method is the use of thermal camera imaging (FLIR).

Such a monitor could increase procedural accuracy and efficiency, thus improving patient care. To plan the prospective treatment options, objective confirmation of successful sympathetic block is essential to differentiate sympathetically mediated pain (SMP) versus sympathetically independent pain (SIP).

In this context, utilization of a monitor with a rapid response and easy clinical applicability, would serve as an objective endpoint for evaluating sympathetic blockade both clinically and for future research.

Therefore, this research proposal aims to investigate the infrared (FLIR) thermal camera as an objective method for determining the achievement of sympathetic block in the clinical setting.

03

Conditions studied

  • Complex Regional Pain Syndromes

Keywords

  • complex
  • regional
  • pain
  • FLIR
  • Sympathetic Block
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study is designed to be implemented in a single center in an academic pain center that is specialized in musculoskeletal pain. In a pain center with a high experience in clinical and academic fields, it is planned to apply lumbar sympathetic blocks to the patients diagnosed with CRPS. The Budapest Clinical Diagnostic Criteria will be used to diagnose CRPS Type 1 patients.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient is between 18 and 85 years old
  • Providing CRPS diagnostic criteria by using Budapest Clinical criteria [16]
  • 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 is a limitation in the patient's functional capacity despite appropriate treatment.

Exclusion criteria

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
  • Pregnancy
  • Uncontrollable medical and psychiatric condition
  • The patients diagnosed with dysautonomia, sympathetic dysfunction (such as Raynaud disease or Buerger disease), sweating disorders (such as acquired idiopathic generalized anhidrosis), and patients on vasoactive drugs, the mechanism of action is directly on the vascular tone.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • FLIR Imaging

    All patients recruited for this study will receive FLIR imaging to monitor the success of a lumbar sympathetic block for CRPS

    Device: Forward Looking Infrared Radar (FLIR) thermal imaging

Interventions

  • DeviceForward Looking Infrared Radar (FLIR) thermal imaging

    The FLIR camera will collect temperature recordings pre-procedure and 5 minutes post-procedure, which will be used to calculate a delta T to assess achievement of a successful sympathetic block.

06

What researchers measure

Primary outcomes

  1. Circulation Improvement

    Improvement of circulation and perfusion in the affected limb by FLIR camera in CRPS patients at a 5-minutes time point after the completion of the block.

    Time frame: 5 minutes post procedure

Secondary outcomes

  1. Comparison between FLIR and Standard Measuring

    The developed quantitative measurement will be compared with the "qualitative assessment of clinical signs of sympathectomy" scale at 5-minute post-procedure to determine which method was superior to detecting sympathetic block.

    Time frame: 5 minutes post procedure

  2. Numerical Pain Score Correlation

    The developed quantitative measurement will be compared with the currently used NRS values at postoperative follow-up (1-2 weeks) time points after completion of the sympathetic block.

    Time frame: 10 days post procedure

07

Study locations

1 site
  • Hospital for Special Surgery
    New York, New York 10021, United States
08

References and documents

Publications

  • Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x. PubMed 18366465 ↗
  • McCormick ZL, Hendrix A, Dayanim D, Clay B, Kirsling A, Harden N. Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial. Pain Med. 2018 Dec 1;19(12):2496-2503. doi: 10.1093/pm/pny041. PubMed 29528455 ↗
  • Krumova EK, Gussone C, Regeniter S, Westermann A, Zenz M, Maier C. Are sympathetic blocks useful for diagnostic purposes? Reg Anesth Pain Med. 2011 Nov-Dec;36(6):560-7. doi: 10.1097/AAP.0b013e318229bbee. PubMed 21941221 ↗
  • Park SY, Nahm FS, Kim YC, Lee SC, Sim SE, Lee SJ. The cut-off rate of skin temperature change to confirm successful lumbar sympathetic block. J Int Med Res. 2010 Jan-Feb;38(1):266-75. doi: 10.1177/147323001003800131. PubMed 20233538 ↗
  • Gungor S, Rana B, Fields K, Bae JJ, Mount L, Buschiazzo V, Storm H. Changes in the Skin Conductance Monitor as an End Point for Sympathetic Nerve Blocks. Pain Med. 2017 Nov 1;18(11):2187-2197. doi: 10.1093/pm/pnw318. PubMed 28158730 ↗
  • Cheng J, Salmasi V, You J, Grille M, Yang D, Mascha EJ, Cheng OT, Zhao F, Rosenquist RW. Outcomes of Sympathetic Blocks in the Management of Complex Regional Pain Syndrome: A Retrospective Cohort Study. Anesthesiology. 2019 Oct;131(4):883-893. doi: 10.1097/ALN.0000000000002899. PubMed 31365367 ↗
  • Gungor S, Aiyer R, Baykoca B. Sympathetic blocks for the treatment of complex regional pain syndrome: A case series. Medicine (Baltimore). 2018 May;97(19):e0705. doi: 10.1097/MD.0000000000010705. PubMed 29742728 ↗
  • Gungor S, Aiyer R. Extrapyramidal signs occurring after sympathetic block for complex regional pain syndrome responding to diphenhydramine: Two case reports. Medicine (Baltimore). 2018 Jun;97(26):e11301. doi: 10.1097/MD.0000000000011301. PubMed 29953015 ↗
  • O'Connell NE, Wand BM, McAuley J, Marston L, Moseley GL. Interventions for treating pain and disability in adults with complex regional pain syndrome. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009416. doi: 10.1002/14651858.CD009416.pub2. PubMed 23633371 ↗
  • Ghosh P, Gungor S. Utilization of Concurrent Dorsal Root Ganglion Stimulation and Dorsal Column Spinal Cord Stimulation in Complex Regional Pain Syndrome. Neuromodulation. 2021 Jun;24(4):769-773. doi: 10.1111/ner.13144. Epub 2020 Mar 11. PubMed 32162402 ↗
  • Noori SA, Gungor S. Spinal epidural abscess associated with an epidural catheter in a woman with complex regional pain syndrome and selective IgG3 deficiency: A case report. Medicine (Baltimore). 2018 Dec;97(50):e13272. doi: 10.1097/MD.0000000000013272. PubMed 30557971 ↗

Individual participant data

Plan to share: No — There is no plan to share individual patient data with other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Jun 2023, 4 months.

Of 18 observational studies under Complex Regional Pain Syndromes, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 147. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2022
First posted
Jan 23, 2023
StartActual
Jan 9, 2023
Primary completionActual
Jun 6, 2023
CompletionActual
Jul 6, 2023
Last update
Dec 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05693337
Responsible party
Sponsor
First posted
Jan 23, 2023
Start date
Jan 9, 2023
Primary completion
Jun 6, 2023
Completion
Jul 6, 2023
Last update
Dec 27, 2024

Study contacts

Semih Gungor, MD
principal investigator · Hospital for Special Surgery, Department of Anesthesiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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