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Clinical Trials/NCT02752386
NCT02752386
Completed
Not Applicable

Biofeedback Training to Control Pain Processing

University of Tulsa1 site in 1 country94 target enrollmentFebruary 2016
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
University of Tulsa
Enrollment
94
Locations
1
Primary Endpoint
Change in nociceptive flexion reflex threshold
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to test whether a novel form of biofeedback training can help individuals regulate their pain more effectively.

Detailed Description

Relaxation is a low-cost treatment for managing pain with little or no side effects. The proposed study will use a novel biofeedback procedure to try to enhance the ability of relaxation to engage pain inhibition. Specifically, a biofeedback system will be used to provide training in conditioned pain regulation. The biofeedback system will monitor the trainee's level of sympathetic arousal and use it to control the intensity of painful stimulations delivered to the trainee during biofeedback. So when the trainee successfully relaxes (and reduced arousal), the intensity is lowered and produces pain relief. Efficacy of the training will be tested in a randomized controlled trial in which healthy, pain-free trainees are assigned to receive 3 training sessions or 3 sessions of a control procedure (2 other procedures will serve as controls; 3 groups total). The aim will be to assess whether the training results in inhibition of experimental pain and the nociceptive flexion reflex (NFR, a physiological marker of spinal pain signaling) to determine whether brain-to-spinal cord inhibitory circuits are engaged.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
July 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Tulsa
Responsible Party
Principal Investigator
Principal Investigator

Jamie Rhudy

Professor

University of Tulsa

Eligibility Criteria

Inclusion Criteria

  • healthy pain free individuals over the age of 18.

Exclusion Criteria

  • under 18 years of age (given the nature of the study)
  • history of serious cardiovascular, neuroendocrine, or neurological disorders
  • hypertension (due to a relationship between blood pressure and pain);5 4) history of chronic pain
  • current opioid, antidepressant, or anxiolytic medication use
  • psychosis or apparent cognitive impairment
  • body mass index\>35 (due to difficulty eliciting an NFR in persons with high adiposity)
  • inability to understand and read English (questionnaires and consent form are in English)
  • recent use of an over-the-counter pain medication (within the last 24 hours) or narcotic medication (within the last two weeks)
  • history of panic attacks. No one will be excluded based on ethnic, racial, or gender characteristics.

Outcomes

Primary Outcomes

Change in nociceptive flexion reflex threshold

Time Frame: Assessed at the beginning and end of each of the 3 biofeedback training days

physiological marker of pain processing

Change in temporal summation of pain

Time Frame: Assessed at the beginning and end of each of the 3 biofeedback training days

marker of pain facilitation (change in pain rating 0-100 that occurs in response to a mechanical stimulus series)

Study Sites (1)

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