Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients

Complex Regional Pain Syndromes Clinical Trial

Official title:

The Effect of Spinal Cord Stimulation on Thermal Forward Looking InfraRed (FLIR) Imaging in Complex Regional Pain Syndrome (CRPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777889
• Other study ID #: 2022-2480
• Status: Recruiting
• Start date: February 22, 2023
• Est. completion date: February 22, 2025

Study information

• Verified date: July 2023
• Source: Hospital for Special Surgery, New York
• Contact: Justas Lauzadis, PhD
• Phone: 212-774-2946
• Email: lauzadisj[@]hss.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 320*240 resolution. Participants will also complete questionnaires about the average pain, CRPS severity, quality of life, and neuropathic pain.

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 320*240 resolution. Participants will also complete questionnaires about the average pain, CRPS severity, quality of life, and neuropathic pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 22, 2025
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• The patient is between 18 and 85 years old
• 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:

• 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 other than CRPS (such as Raynaud disease or Buerger disease), sweating disorders other than CRPS (such as acquired idiopathic generalized anhidrosis), and patients

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Forward Looking InfraRed Camera
Forward Looking InfraRed Camera: We will use a FLIR T420 or T62101 camera with a resolution of 320*240. Each image will be captured perpendicularly with a 1-inch gap on all four sides. A Myler blanket placed in the background will separate the feet from the background. The camera will be normalized to a temperature range of 15°C to 40°C. The images will be saved in radiometric JPEG format. Once the images have been transferred to a computer, we will remove the background. Next, we'll make a temperature histogram with 0.1°C temperature bin resolution. The before and after histograms (IB, IA) will be compared to see which one indicates more extreme temperature distributions. Those who improve by 30% or more are considered to have had a successful spinal cord stimulation.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (8)

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/S014 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at a 48 hours after spinal cord stimulation will mean there was improvement.	at 48 hours after spinal cord stimulation
Secondary	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.	at post-operative day, at 48 hours after surgery, and 1-2 weeks after surgery
Secondary	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 (1-2 weeks) 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.	at intra-operative (during surgery) and at 1-2 weeks after surgery
Secondary	Difference in participant's level of Health Related Quality of Life (HRQoL)	The Health-Related Quality of Life (HRQOL-14) scale has 14 items that give a complete overview of a person's health and wellbeing. The four HRQOL questions measure: (1) self-perceived health (excellent, very good, good, fair, or poor), (2) number of days out of the past 30 that physical health was not good, (3) number of days out of the past 30 that mental health was not good, and (4) number of days out of the past 30 that usual activities were limited by poor physical or mental health. Follow by ten additional questions about health-related quality of life.; A quantitative measure on delta thermal camera value that shows a difference of 50% or higher in correlation to HRQoL values (the delta pain QoL value). The developed quantitative measurement will be compared with the currently used HRQoL values at postoperative follow-up (1-2 weeks) timepoints after completion of the SCS.	at intra-operative (during surgery) and at 1-2 weeks after surgery
Secondary	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 (1-2 weeks) time points after completion of the SCS.)	At Post-operative Day 1 and 1-2 weeks after surgery