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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forward Looking InfraRed Camera | Other | Forward Looking InfraRed Camera:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-8 days after the trial procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-8 days after the trial procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosised with complex regional pain syndrome, undergoing a surgery that requires spinal cord stimulation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pa Thor, PhD | Contact | 646-797-8535 | thorp@hss.edu |
| Name | Affiliation | Role |
|---|---|---|
| Semih Gungor, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35687369 | Result | 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. | |
| 12020526 | Result | 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. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Beginning 9 months and ending 36 months following article publication
For researchers who provide a methodologically sound proposal and analyses to achieve aims in the approved proposal. Proposals should be directed to siderisa@hss.edu. To gain access, data requestors will need to sign a data access agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2023 | Feb 27, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| 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. | 2-8 days after the trial procedure |
| 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.) | 2-8 days after the trial procedure |
| 9124459 | Result | 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. |
| 3257679 | Result | 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. |
| 1671794 | Result | 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. |
| 21992784 | Result | 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. |
| 17610454 | Result | 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. |
| 20965657 | Result | 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. |