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Advancement of Psychophysics of Pain Modulation From Lab to Clinic: Constructing Susceptibility Profile for Appearance of Postoperative Neuropathic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305136
First Posted: March 21, 2006
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Israel Scientific Foundation
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus
  Purpose

Recent advances in the field of pain psychophysics that have enhanced the understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery.

In this project, the researchers propose to apply a wide array of advanced testing methods in order to prospectively assess the pain modulation pattern of pain free patients about to undergo an elective thoracotomy. Since about half of post-thoracotomy patients suffer from chronic neuropathic postoperative pain, the researchers expect to identify which tests predict a risk for this pain and the relative power of the relevant tests in this prediction, and to construct a short and applicable tool, the 'pain susceptibility profile', that will reliably predict the risk for the development of pain. The expected results of this project will serve the field of pain prevention by identifying patients at risk and tailoring interventions to reduce the risk of chronic pain.


Condition
Pain, Postoperative

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advancement of Psychophysics of Pain Modulation From Lab to Clinic: Constructing Susceptibility Profile for Appearance of Postoperative Neuropathic Pain

Further study details as provided by d_yarnitsky, Rambam Health Care Campus:

Enrollment: 200
Actual Study Start Date: December 2005
Study Completion Date: December 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The common prevalence of painful syndromes following surgical interventions and injuries calls for a preventive therapeutic approach that can only be based on better insight into the pain modulation mechanisms in these patients. Recent advances in the field of pain psychophysics that have enhanced our understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery.

In this project, we propose to apply a wide array of advanced testing methods in order to prospectively assess the pain modulation pattern of pain free patients about to undergo an elective thoracotomy. Tests will include:

  1. psychophysical tests: pain thresholds and suprathreshold magnitude estimation, temporal summation, endogenous analgesia - diffuse noxious inhibitory control (DNIC);
  2. tests for the interaction between pain and the autonomic nervous system including the inhibitory effect of vagal activation on pain perception, and the response pattern of the sympatho-parasympathetic balance to noxious stimulation; and
  3. evaluation of personality components known to be associated with chronic pain including anxiety, catastrophization and somatization.

Since about half of post-thoracotomy patients suffer from chronic neuropathic postoperative pain, we expect to identify which tests predict a risk for this pain and the relative power of the relevant tests in this prediction, and to construct a short and applicable tool, the 'pain susceptibility profile', that will reliably predict the risk for the development of pain. The contribution of the above tests to the severity of acute postoperative pain, and of the latter on the development of the chronic postoperative pain will also be evaluated.

The expected results of this project will serve pain prevention by identifying patients at risk and tailoring interventions to reduce the risk of chronic pain. Also, in the wider pain research context, this understanding will allow better design and analysis of studies on pain mechanisms and therapies by considering the pain susceptibility of participating patients.

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  • Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases.

Exclusion Criteria:

  • Psychiatric or cognitive dysfunction precluding use of psychophysics
  • Existing thoracic pain
  • Patients who cannot communicate in Hebrew
Criteria

Inclusion Criteria:

  • Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases.

Exclusion Criteria:

  • Psychiatric or cognitive dysfunction precluding use of psychophysics
  • Existing thoracic pain
  • Patients who cannot communicate in Hebrew
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305136


Locations
Israel
Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Israel Scientific Foundation
Investigators
Principal Investigator: David Yarnitsky, Professor Neurology Department Chairman, Rambam Medical Center, Haifa, Israel
  More Information

Responsible Party: d_yarnitsky, Head of Neurology department, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00305136     History of Changes
Other Study ID Numbers: Thoracotomy02CTIL
ISF
First Submitted: March 19, 2006
First Posted: March 21, 2006
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by d_yarnitsky, Rambam Health Care Campus:
thoracotomy
post-operative pain
chronic pain
endogenous analgesia
temporal summation
central sensitization
prediction
Patients Who Should Undergo Thoracotomy

Additional relevant MeSH terms:
Neuralgia
Pain, Postoperative
Disease Susceptibility
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Disease Attributes