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

Last updated: December 23, 2024
Sponsor: Hospital for Special Surgery, New York
Overall Status: Active - Recruiting

Phase

N/A

Condition

Somatoform And Dissociative Disorders

Reflex Sympathetic Dystrophy Syndrome (Rsds)

Mood Disorders

Treatment

Forward Looking InfraRed Camera

Clinical Study ID

NCT05777889
2022-2480
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient is between 18 and 85 years old

  • Providing CRPS diagnostic criteria by using the Budapest Clinical DiagnosticCriteria.

  • 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 appropriatetreatment.

Exclusion

Exclusion Criteria:

  • Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspectedradiculopathy 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

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Forward Looking InfraRed Camera
Phase:
Study Start date:
February 22, 2023
Estimated Completion Date:
February 22, 2026

Study 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.

Connect with a study center

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Active - Recruiting

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