Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients (SCS-FLIR)

Hospital for Special Surgery (HSS)

Status: Enrolling

Conditions: Complex Regional Pain Syndromes

Treatments: Other: Forward Looking InfraRed Camera

Study type: Observational

Funder types: Other

Identifiers

NCT05777889

2022-2480

Details and patient eligibility

About

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), 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, and neuropathic pain.

Full 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), 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, and neuropathic pain.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is between 18 and 85 years old
• Providing CRPS diagnostic criteria by using the Budapest Clinical Diagnostic Criteria.
• CRPS affecting unilateral lower extremity
• 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

Trial design

12 participants in 1 patient group

Study CRPS Group

Description:

Enrolled patients with complex regional pain syndrome undergoing a surgical procedure that requires spinal cord stimulation. All participants in the group 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. All participants will also answer questionnaires about: their average pain score, CRPS severity, and neuropathic pain.

Treatment:

Other: Forward Looking InfraRed Camera