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Completed

NCT Number: NCT05693337

Infrared Imaging in Complex Regional Pain Syndrome

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Forward Looking Infrared Radar (FLIR) thermal imaging

Device

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.

Primary outcomes

  1. Circulation Improvement

    Time frame: 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 outcomes

  1. Comparison between FLIR and Standard Measuring

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Infrared (FLIR) Imaging as a Monitor for Sympathetic Blocks in Complex Regional Pain Syndrome (CRPS)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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