Infrared Imaging in Complex Regional Pain Syndrome

NCT05693337 | Completed FDA Device

• 1 other identifier: 2022-1996
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Complex Regional Pain Syndromes

Keywords

complex; regional; pain; FLIR; Sympathetic Block

Outcome Measures

Primary Outcomes (1)

• Circulation Improvement

  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.

  5 minutes post procedure

Secondary Outcomes (2)

• Comparison between FLIR and Standard Measuring

  5 minutes post procedure

• Numerical Pain Score Correlation

  10 days post procedure

Study Arms (1)

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

Interventions

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.

FLIR Imaging

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is designed to be implemented in a single center in an academic pain center that is specialized in musculoskeletal pain. In a pain center with a high experience in clinical and academic fields, it is planned to apply lumbar sympathetic blocks to the patients diagnosed with CRPS. The Budapest Clinical Diagnostic Criteria will be used to diagnose CRPS Type 1 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (11)

• Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x.

  PMID: 18366465 BACKGROUND

• McCormick ZL, Hendrix A, Dayanim D, Clay B, Kirsling A, Harden N. Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial. Pain Med. 2018 Dec 1;19(12):2496-2503. doi: 10.1093/pm/pny041.

  PMID: 29528455 BACKGROUND

• Krumova EK, Gussone C, Regeniter S, Westermann A, Zenz M, Maier C. Are sympathetic blocks useful for diagnostic purposes? Reg Anesth Pain Med. 2011 Nov-Dec;36(6):560-7. doi: 10.1097/AAP.0b013e318229bbee.

  PMID: 21941221 BACKGROUND

• Park SY, Nahm FS, Kim YC, Lee SC, Sim SE, Lee SJ. The cut-off rate of skin temperature change to confirm successful lumbar sympathetic block. J Int Med Res. 2010 Jan-Feb;38(1):266-75. doi: 10.1177/147323001003800131.

  PMID: 20233538 BACKGROUND

• Gungor S, Rana B, Fields K, Bae JJ, Mount L, Buschiazzo V, Storm H. Changes in the Skin Conductance Monitor as an End Point for Sympathetic Nerve Blocks. Pain Med. 2017 Nov 1;18(11):2187-2197. doi: 10.1093/pm/pnw318.

  PMID: 28158730 BACKGROUND

• Cheng J, Salmasi V, You J, Grille M, Yang D, Mascha EJ, Cheng OT, Zhao F, Rosenquist RW. Outcomes of Sympathetic Blocks in the Management of Complex Regional Pain Syndrome: A Retrospective Cohort Study. Anesthesiology. 2019 Oct;131(4):883-893. doi: 10.1097/ALN.0000000000002899.

  PMID: 31365367 BACKGROUND

• Gungor S, Aiyer R, Baykoca B. Sympathetic blocks for the treatment of complex regional pain syndrome: A case series. Medicine (Baltimore). 2018 May;97(19):e0705. doi: 10.1097/MD.0000000000010705.

  PMID: 29742728 BACKGROUND

• Gungor S, Aiyer R. Extrapyramidal signs occurring after sympathetic block for complex regional pain syndrome responding to diphenhydramine: Two case reports. Medicine (Baltimore). 2018 Jun;97(26):e11301. doi: 10.1097/MD.0000000000011301.

  PMID: 29953015 BACKGROUND

• O'Connell NE, Wand BM, McAuley J, Marston L, Moseley GL. Interventions for treating pain and disability in adults with complex regional pain syndrome. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009416. doi: 10.1002/14651858.CD009416.pub2.

  PMID: 23633371 BACKGROUND

• Ghosh P, Gungor S. Utilization of Concurrent Dorsal Root Ganglion Stimulation and Dorsal Column Spinal Cord Stimulation in Complex Regional Pain Syndrome. Neuromodulation. 2021 Jun;24(4):769-773. doi: 10.1111/ner.13144. Epub 2020 Mar 11.

  PMID: 32162402 BACKGROUND

• Noori SA, Gungor S. Spinal epidural abscess associated with an epidural catheter in a woman with complex regional pain syndrome and selective IgG3 deficiency: A case report. Medicine (Baltimore). 2018 Dec;97(50):e13272. doi: 10.1097/MD.0000000000013272.

  PMID: 30557971 BACKGROUND

Related Links

• London: Royal College of Physicians

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Semih Gungor, MD

  Hospital for Special Surgery, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: January 23, 2023
• Study Start: January 9, 2023
• Primary Completion: June 6, 2023
• Study Completion: July 6, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)