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OpenTrials
Completed

NCT Number: NCT02752386

Biofeedback Training to Control Pain Processing

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tulsa

Tulsa, Oklahoma, 74104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biofeedback training

Behavioral

Participants will received biofeedback training to reduce arousal and pain

Primary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Tulsa

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2016
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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