Near-infrared Spectroscopic Measurement in Complex Regional Pain Syndrome

NCT01586377 | Completed DMC

• 2 other identifiers: R-11-38218119
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recent clinical investigations have suggested that the cause of abnormal pain in complex regional pain syndrome could be ischemia and inflammation, due to poor blood flow to deep tissues from microvascular pathology. This study aims to determine if a new technology called near infrared spectroscopy can measure this microvascular dysfunction. The study hypothesizes that significant differences can be measured in the microcirculation of patients with CRPS-I using near infrared spectroscopy and the vascular occlusion test.

Conditions

Reflex Sympathetic Dystrophy

Keywords

Complex regional pain syndrome; Near Infrared Spectroscopy; Vascular Occlusion Test

Outcome Measures

Primary Outcomes (1)

• Baseline tissue oxygen saturation

  Day 1

Secondary Outcomes (5)

• Occlusion slope during vascular occlusion test

  Day 1

• Reperfusion slope during vascular occlusion test

  Day 1

• Delta StO2

  Day 1

• Post-obstructive hyperemic response

  Day 1

• Thenar muscle oxygen consumption

  Day 1

Study Arms (2)

CRPS Type 1

Patients with CRPS 1 affecting a single upper limb

Healthy volunteers

Volunteers without the diagnosis of CRPS Type 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CRPS Type 1 will be selected from a tertiary care chronic pain clinic. Healthy volunteers will be selected from a community sample

You may qualify if:

• Complex regional pain syndrome type 1 (CRPS-I) of one upper extremity.
• Healthy volunteers.
• Diagnosis of CRPS-I established for greater than 12 weeks.

You may not qualify if:

• Pregnancy
• Lack of informed consent
• History of peripheral vascular disease requiring angioplasty or bypass surgery
• History of systemic vasculitis
• Current use of vasoactive medications
• Diabetes Type I and II
• Presently smoking

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Pain Clinic, St. Joseph's Health Care London Hospitals

London, Ontario, N6A 4V2, Canada

Location

Related Publications (10)

• Birklein F, Weber M, Neundorfer B. Increased skin lactate in complex regional pain syndrome: evidence for tissue hypoxia? Neurology. 2000 Oct 24;55(8):1213-5. doi: 10.1212/wnl.55.8.1213.

  PMID: 11071503 BACKGROUND

• Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008 Jun;14(3):361-6. doi: 10.1097/MCC.0b013e3282fad4e1.

  PMID: 18467900 BACKGROUND

• Coderre TJ, Bennett GJ. A hypothesis for the cause of complex regional pain syndrome-type I (reflex sympathetic dystrophy): pain due to deep-tissue microvascular pathology. Pain Med. 2010 Aug;11(8):1224-38. doi: 10.1111/j.1526-4637.2010.00911.x.

  PMID: 20704671 BACKGROUND

• Dayan L, Salman S, Norman D, Vatine JJ, Calif E, Jacob G. Exaggerated vasoconstriction in complex regional pain syndrome-1 is associated with impaired resistance artery endothelial function and local vascular reflexes. J Rheumatol. 2008 Jul;35(7):1339-45. Epub 2008 May 1.

  PMID: 18464300 BACKGROUND

• De Backer D, Ospina-Tascon G, Salgado D, Favory R, Creteur J, Vincent JL. Monitoring the microcirculation in the critically ill patient: current methods and future approaches. Intensive Care Med. 2010 Nov;36(11):1813-25. doi: 10.1007/s00134-010-2005-3. Epub 2010 Aug 6.

  PMID: 20689916 BACKGROUND

• Doerschug KC, Delsing AS, Schmidt GA, Haynes WG. Impairments in microvascular reactivity are related to organ failure in human sepsis. Am J Physiol Heart Circ Physiol. 2007 Aug;293(2):H1065-71. doi: 10.1152/ajpheart.01237.2006. Epub 2007 May 4.

  PMID: 17483235 BACKGROUND

• Groeneweg JG, Huygen FJ, Heijmans-Antonissen C, Niehof S, Zijlstra FJ. Increased endothelin-1 and diminished nitric oxide levels in blister fluids of patients with intermediate cold type complex regional pain syndrome type 1. BMC Musculoskelet Disord. 2006 Nov 30;7:91. doi: 10.1186/1471-2474-7-91.

  PMID: 17137491 BACKGROUND

• Harel F, Denault A, Ngo Q, Dupuis J, Khairy P. Near-infrared spectroscopy to monitor peripheral blood flow perfusion. J Clin Monit Comput. 2008 Feb;22(1):37-43. doi: 10.1007/s10877-007-9105-9. Epub 2007 Nov 27.

  PMID: 18040873 BACKGROUND

• Skarda DE, Mulier KE, Myers DE, Taylor JH, Beilman GJ. Dynamic near-infrared spectroscopy measurements in patients with severe sepsis. Shock. 2007 Apr;27(4):348-53. doi: 10.1097/01.shk.0000239779.25775.e4.

  PMID: 17414414 BACKGROUND

• Bellingham GA, Smith RS, Morley-Forster P, Murkin JM. Use of near infrared spectroscopy to detect impaired tissue oxygen saturation in patients with complex regional pain syndrome type 1. Can J Anaesth. 2014 Jun;61(6):563-70. doi: 10.1007/s12630-014-0140-y. Epub 2014 Mar 26.

  PMID: 24668314 DERIVED

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Geoff A Bellingham, MD FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 26, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

CA (1)