Biofeedback Training to Control Pain Processing

NCT ID: NCT02752386

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-07-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biofeedback Training

Intervention Type: BEHAVIORAL

Participants will received biofeedback training to reduce arousal and pain

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.

Group Type: ACTIVE_COMPARATOR

Biofeedback Training

Intervention Type: BEHAVIORAL

Participants will received biofeedback training to reduce arousal and pain

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.

Group Type: ACTIVE_COMPARATOR

Biofeedback Training

Intervention Type: BEHAVIORAL

Participants will received biofeedback training to reduce arousal and pain

Interventions

Biofeedback Training

Participants will received biofeedback training to reduce arousal and pain

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Tulsa

OTHER

Sponsor Role: lead

Responsible Party

Jamie Rhudy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie L Rhudy, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Tulsa

Locations

University of Tulsa

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

TU1560

Identifier Type: -

Identifier Source: org_study_id