Complex Regional Pain SyndromesNCT05693337
Infrared Imaging in Complex Regional Pain Syndrome
An observational study of Complex Regional Pain Syndromes, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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 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 Radar (FLIR) thermal imaging
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 6 Jul 2023
- 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: 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.
Who may be able to join
- 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.
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 (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Infrared (FLIR) Imaging as a Monitor for Sympathetic Blocks in Complex Regional Pain Syndrome (CRPS)
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.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Forward Looking Infrared Radar (FLIR) thermal imaging
- Keywords
- complex, regional, pain, FLIR, Sympathetic Block
- Medical subject headings
- Complex Regional Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forward Looking Infrared Radar (FLIR) thermal imagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FLIR Imaging | All patients recruited for this study will receive FLIR imaging to monitor the success of a lumbar sympathetic block for CRPS Receives: Device: Forward Looking Infrared Radar (FLIR) thermal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes post procedure
Secondary outcomes (2)
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.
Measured: 5 minutes post procedure
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.
Measured: 10 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start9 Jan 2023
- Primary completion6 Jun 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Semih Gungor, MD, Principal investigator, Hospital for Special Surgery, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693337
- Sponsor's protocol ID
- 2022-1996
- Status last verified
- Dec 2024
- First submitted
- 9 Sep 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual patient data with other researchers.
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 18366465McCormick 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 29528455Krumova 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 21941221Park 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 20233538Gungor 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 28158730Cheng 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 31365367Gungor 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 29742728Gungor 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 29953015O'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 23633371Ghosh 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 32162402Noori 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared (FLIR) Imaging as a Monitor for Sympathetic Blocks in Complex Regional Pain Syndrome (CRPS)
- ClinicalTrials.gov ID
- NCT05693337
- Acronym / sponsor ID
- 2022-1996
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- complex, regional, pain, FLIR, Sympathetic Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLIR Imaging | – | Device: Forward Looking Infrared Radar (FLIR) thermal imagingAll patients recruited for this study will receive FLIR imaging to monitor the success of a lumbar sympathetic block for CRPS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forward Looking Infrared Radar (FLIR) thermal imagingThe 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. | Device | FLIR Imaging |
Primary outcome
Circulation Improvement
Time frame: 5 minutes post procedure
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.
2 secondary outcomes
Comparison between FLIR and Standard Measuring
Time frame: 5 minutes post procedure
Numerical Pain Score Correlation
Time frame: 10 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 18366465Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x.
- Background: PubMed 29528455McCormick 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.
- Background: PubMed 21941221Krumova 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.
- Background: PubMed 20233538Park 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.
- Background: PubMed 28158730Gungor 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.
- Background: PubMed 31365367Cheng 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.
- Background: PubMed 29742728Gungor 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.
- Background: PubMed 29953015Gungor 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.
- Background: PubMed 23633371O'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.
- Background: PubMed 32162402Ghosh 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.
- Background: PubMed 30557971Noori 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.
- London: Royal College of PhysiciansLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual patient data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semih Gungor, MD principal investigator
Hospital for Special Surgery, Department of Anesthesiology
1 site in 1 country: see every site and its status.
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 6 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: finished, as of the sponsor's last update on 27 Dec 2024. 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?
Circulation Improvement (time frame: 5 minutes post 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 NCT05693337, which also lists 11 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 27 Dec 2024.