Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition.
R Norman Harden, Candida S McCabe, Andreas Goebel...
https://pubmed.ncbi.nlm.nih.gov/35687369Actively Recruiting
Age: 18Years - 85Years
All Genders
ID05777889
The Effect of Spinal Cord Stimulation on Thermal Forward Looking InfraRed Imaging in Complex Regional Pain Syndrome
Led by Hospital for Special Surgery, New York · Updated on 2025-11-26
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study focuses on patients with complex regional pain syndrome (CRPS) who experience sympathetic dysfunction and peripheral blood flow problems. Researchers aim to evaluate whether Forward Looking Infrared (FLIR) imaging can detect changes in sympathetic activity caused by spinal cord stimulation (SCS) in the affected limb. The study also seeks to find correlations between the imaging results and clinical measures such as pain levels, CRPS severity, and neuropathic pain scores. Participants with CRPS who are undergoing spinal cord stimulation will have thermal images taken of their feet using a FLIR T420 or T62101 camera with 320x240 resolution. Images are captured perpendicularly with a 1-inch space from all sides, using a Myler blanket as background separation. They will also complete questionnaires about their average pain, CRPS severity, and neuropathic pain. The study compares images taken before and 2 to 8 days after the stimulation procedure to assess temperature differences and sympatholytic effects. During the study, participants provide thermal images and complete pain and symptom questionnaires. The primary outcome is the temperature difference in the affected limb after spinal cord stimulation. Secondary outcomes include average pain rating using the Numerical Rating Scale (NRS), CRPS Severity Score (CSS), and Neuropathic Pain Score (PainDetect). The study runs up to 2 to 8 days after the procedure, with data collected to understand the relationship between SCS effects and sympathetic activity in CRPS patients.
CONDITIONS
Brief Title
Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- The patient is between 18 and 85 years old
- Diagnosis of complex regional pain syndrome (CRPS) by Budapest Clinical Diagnostic Criteria
- CRPS affecting one lower limb only
- Pain and symptoms lasting more than 3 months
- Not responding to conventional medical treatment and multidisciplinary care
- High pain score (NRS 6 or above) despite treatment
- Pain limiting functional ability despite treatment
You will not qualify if you...
- Suspected disc herniation, spinal stenosis, myelopathy, or radiculopathy based on MRI or CT
- Presence of systemic or local infection
- Coagulation disorders
- History of allergy to contrast material
- Malignancy
- Pregnancy
- Uncontrolled medical or psychiatric conditions
- Diagnosed with other dysautonomia or sympathetic dysfunctions like Raynaud or Buerger disease
- Sweating disorders other than CRPS such as acquired idiopathic generalized anhidrosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 2 to 8 days
Participants will have thermal images of their feet taken using a Forward Looking InfraRed (FLIR) camera and will complete questionnaires about their pain and CRPS severity to monitor sympathetic activity before and after spinal cord stimulation.
2 visits (in-person) for imaging and questionnaires before and after spinal cord stimulation
Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
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Research Team
P
Pa Thor, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study.
R Baron, J Schattschneider, A Binder...
https://pubmed.ncbi.nlm.nih.gov/12020526Cutaneous vasodilation during dorsal column stimulation is mediated by dorsal roots and CGRP.
J E Croom, R D Foreman, M J Chandler...
https://pubmed.ncbi.nlm.nih.gov/9124459Epidural spinal cord electrical stimulation improves microvascular blood flow in severe limb ischemia.
M J Jacobs, P J Jörning, S R Joshi...
https://pubmed.ncbi.nlm.nih.gov/3257679Peripheral vasodilatation after spinal cord stimulation: animal studies of putative effector mechanisms.
B Linderoth, I Fedorcsak, B A Meyerson
https://pubmed.ncbi.nlm.nih.gov/1671794Thermogram in spinal cord stimulation with complex regional pain syndrome and a review of the literature.
Billy Keon Huh, Chan-Hong Park, Matthew Ranson...
https://pubmed.ncbi.nlm.nih.gov/21992784Proposed new diagnostic criteria for complex regional pain syndrome.
R Norman Harden, Stephen Bruehl, Michael Stanton-Hicks...
https://pubmed.ncbi.nlm.nih.gov/17610454Development of a severity score for CRPS.
Norman R Harden, Stephen Bruehl, Roberto S G M Perez...
https://pubmed.ncbi.nlm.nih.gov/20965657