Biofeedback Training to Control Pain Processing

NCT02752386 | Completed

• 1 other identifier: TU1560
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Change in nociceptive flexion reflex threshold

  physiological marker of pain processing

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

• Change in temporal summation of pain

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

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

Study Arms (3)

Biofeedback Training 1

EXPERIMENTAL

Participants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback to provide pain relief when relaxation is achieved.

Behavioral: Biofeedback Training

Biofeedback Training 2

ACTIVE COMPARATOR

Participants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback to provide a painful context in which to practice relaxing.

Behavioral: Biofeedback Training

Biofeedback Training 3

ACTIVE COMPARATOR

Participants will receive brief training in relaxation and biofeedback to develop basic skills in relaxation/arousal reduction. Then they will receive instructions to relax and reduce arousal as they view graphical arousal feedback.

Behavioral: Biofeedback Training

Interventions

Biofeedback Training BEHAVIORAL

Participants will received biofeedback training to reduce arousal and pain

Biofeedback Training 1; Biofeedback Training 2; Biofeedback Training 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy pain free individuals over the age of 18.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tulsa: lead

Study Sites (1)

University of Tulsa

Tulsa, Oklahoma, 74104, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamie L Rhudy, PhD

  The University of Tulsa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 27, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 31, 2018
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)