Infrared Imaging in Complex Regional Pain Syndrome

Complex Regional Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693337
• Other study ID #: 2022-1996
• Status: Completed
• Start date: January 9, 2023
• Est. completion date: July 6, 2023

Study information

• Verified date: September 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x. Erratum In: Pain Pract. 2008 Jul-Aug;18(4):335-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison between FLIR and Standard Measuring	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.	5 minutes post procedure
Secondary	Numerical Pain Score Correlation	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.	10 days post procedure

External Links

•   London: Royal College of Physicians