Image

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

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

Recruiting
18-85 years
All
Phase N/A

Powered by AI

Overview

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.

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

Study details
    Complex Regional Pain Syndromes

NCT05777889

Hospital for Special Surgery, New York

24 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.