Infrared Imaging in Complex Regional Pain Syndrome

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Recruiting
CT.gov ID
NCT05693337
Collaborator
(none)
150
1
24.8
6.1

Study Details

Study Description

Brief Summary

This research proposal aims to investigate the potential use of Infrared (FLIR) imaging to monitor the successful achievement of the sympathetic blockade in patients with complex regional pain syndrome (CRPS).

Condition or Disease Intervention/Treatment Phase
  • Device: Forward Looking Infrared Radar (FLIR) thermal imaging

Detailed Description

Sympathetic blocks are clinically used to diagnose and treat sympathetically mediated pain. Despite the frequent use of these blocks, there remains a need for an objective method to determine the achievement of a sympathetic block in the clinical setting.

Current clinical practice assess the success of a sympathetic block by observation of clinical signs of sympathetic blockade. These signs include monitoring skin temperature, pulse amplitude, blood oxygen, or any combination of these methods. However, clinical signs of sympathetic blockade often demonstrate an unpredictable or delayed response and can make monitoring difficult.

Therefore, it is necessary to develop an objective monitoring method that is reliable, rapid response, and not affected by the other confounders. One potential method is the use of thermal camera imaging (FLIR).

Such a monitor could increase procedural accuracy and efficiency, thus improving patient care. To plan the prospective treatment options, objective confirmation of successful sympathetic block is essential to differentiate sympathetically mediated pain (SMP) versus sympathetically independent pain (SIP).

In this context, utilization of a monitor with a rapid response and easy clinical applicability, would serve as an objective endpoint for evaluating sympathetic blockade both clinically and for future research.

Therefore, this research proposal aims to investigate the infrared (FLIR) thermal camera as an objective method for determining the achievement of sympathetic block in the clinical setting.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Infrared (FLIR) Imaging as a Monitor for Sympathetic Blocks in Complex Regional Pain Syndrome (CRPS)
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
FLIR Imaging

All patients recruited for this study will receive FLIR imaging to monitor the success of a lumbar sympathetic block for CRPS

Device: Forward Looking Infrared Radar (FLIR) thermal imaging
The FLIR camera will collect temperature recordings pre-procedure and 5 minutes post-procedure, which will be used to calculate a delta T to assess achievement of a successful sympathetic block.

Outcome Measures

Primary Outcome Measures

  1. Circulation Improvement [5 minutes post procedure]

    Improvement of circulation and perfusion in the affected limb by FLIR camera in CRPS patients at a 5-minutes time point after the completion of the block.

Secondary Outcome Measures

  1. Comparison between FLIR and Standard Measuring [5 minutes post procedure]

    The developed quantitative measurement will be compared with the "qualitative assessment of clinical signs of sympathectomy" scale at 5-minute post-procedure to determine which method was superior to detecting sympathetic block.

  2. Numerical Pain Score Correlation [10 days post procedure]

    The developed quantitative measurement will be compared with the currently used NRS values at postoperative follow-up (1-2 weeks) time points after completion of the sympathetic block.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The patient is between 18 and 85 years old

  • Providing CRPS diagnostic criteria by using Budapest Clinical criteria [16]

  • 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 is 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 (such as Raynaud disease or Buerger disease), sweating disorders (such as acquired idiopathic generalized anhidrosis), and patients on vasoactive drugs, the mechanism of action is directly on the vascular tone.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital for Special Surgery New York New York United States 10021

Sponsors and Collaborators

  • Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Semih Gungor, MD, Hospital for Special Surgery, Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT05693337
Other Study ID Numbers:
  • 2022-1996
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Hospital for Special Surgery, New York
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023