Biofeedback Training to Control Pain Processing

Not Applicable

Completed

• Conditions: Pain
• Interventions: Behavioral: Biofeedback Training

• Registration Number: NCT02752386
• Lead Sponsor: University of Tulsa

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-27
• Primary Completion: 2018-07
• Study Completion: 2018-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback Training 3	Biofeedback Training	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.
Biofeedback Training 1	Biofeedback Training	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.
Biofeedback Training 2	Biofeedback Training	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.

Primary Outcome Measures

Name	Time	Method
Change in nociceptive flexion reflex threshold	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	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)

Trial Locations

Locations (1)

University of Tulsa; 🇺🇸 Tulsa, Oklahoma, United States