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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Biofeedback Training

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • University of Tulsa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback Training 1; 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; Participants will received biofeedback training to reduce arousal and pain
Active Comparator: Biofeedback Training 2; 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; Participants will received biofeedback training to reduce arousal and pain
Active Comparator: Biofeedback Training 3; 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; Participants will received biofeedback training to reduce arousal and pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Tulsa

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TU1560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO