Clinical trial NCT05777889: Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients
Official title: The Effect of Spinal Cord Stimulation on Thermal Forward Looking InfraRed (FLIR) Imaging in Complex Regional Pain Syndrome (CRPS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complex Regional Pain Syndromes
Keywords: spinal
infrared
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosised with complex regional pain syndrome, undergoing a surgery that requires spinal cord stimulation.

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 320\*240 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 320\*240 resolution.

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

Eligibility criteria: 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

Primary outcomes:
measure: Temperature difference in limb
timeFrame: at 48 hours after spinal cord stimulation
Secondary outcomes:
measure: Average Numerical Rating Scale (NRS) Pain
timeFrame: at post-operative day, at 48 hours after surgery, and 1-2 weeks after surgery
measure: Complex Regional Pain Syndrome Severity Score (CSS)
timeFrame: at intra-operative (during surgery) and at 1-2 weeks after surgery
measure: Difference in participant's level of Health Related Quality of Life (HRQoL)
timeFrame: at intra-operative (during surgery) and at 1-2 weeks after surgery
measure: Average level of Neuropathic Pain Score (PainDetect-PD)
timeFrame: At Post-operative Day 1 and 1-2 weeks after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Semih Gungor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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: 10.1016/j.pain.2010.09.031. Epub 2010 Oct 20.