Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients
NCT ID: NCT05777889
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
10 participants
OBSERVATIONAL
2023-02-22
2026-02-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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), Quality of Life (SF-36), 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, quality of life, and neuropathic pain.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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), Quality of Life (SF-36), 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, quality of life, and neuropathic pain.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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, quality of life, and neuropathic pain.
Forward Looking InfraRed Camera
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Forward Looking InfraRed Camera
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Providing CRPS diagnostic criteria by using the Budapest Clinical Diagnostic Criteria.
* 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.
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital for Special Surgery, New York
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Semih Gungor, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital for Special Surgery
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Justas Lauzadis, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-2480
Identifier Type: -
Identifier Source: org_study_id