Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777889
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-03-09
Brief Title:
Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
The Effect of Spinal Cord Stimulation on Thermal Forward Looking InfraRed FLIR Imaging in Complex Regional Pain Syndrome CRPS
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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 320240 resolution
Participants will also complete questionnaires about the average pain CRPS severity quality of life and neuropathic pain
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 320240 resolution
Participants will also complete questionnaires about the average pain CRPS severity quality of life and neuropathic pain
Detailed Description:
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 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 320240 resolution
Participants will also complete questionnaires about the average pain CRPS severity quality of life and neuropathic pain
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 320240 resolution
Participants will also complete questionnaires about the average pain CRPS severity quality of life and neuropathic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None