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CompletedNCT00305136Updated Oct 11, 2017

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

An observational study in Pain, Postoperative, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Rambam Health Care Campus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pain, Postoperative

Keywords

  • thoracotomy
  • post-operative pain
  • chronic pain
  • endogenous analgesia
  • temporal summation
  • central sensitization
  • prediction
  • Patients Who Should Undergo Thoracotomy
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 200 is above the median of 100 across 260 observational studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Psychiatric or cognitive dysfunction precluding use of psychophysics
  • Existing thoracic pain
  • Patients who cannot communicate in Hebrew
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
06

Study locations

1 site
  • Rambam Medical Center
    Haifa, 31096, Israel
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00305136
Lead sponsor
Rambam Health Care Campus
Collaborators
Israel Scientific Foundation
Responsible party
d_yarnitsky (Head of Neurology department, Rambam Health Care Campus) — Principal investigator
First posted
Mar 21, 2006
Start date
Dec 2005
Primary completion
Jan 2010
Completion
Dec 2011
Last update
Oct 11, 2017

Study contacts

David Yarnitsky, Professor
principal investigator · Neurology Department Chairman, Rambam Medical Center, Haifa, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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