Biofeedback Training to Control Pain Processing

University of Tulsa

Status: Completed

Conditions: Pain

Treatments: Behavioral: Biofeedback Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02752386

TU1560

Details and patient eligibility

About

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

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

Biofeedback Training 1

Experimental group

Description:

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.

Treatment:

Behavioral: Biofeedback Training

Biofeedback Training 2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Biofeedback Training

Biofeedback Training 3

Active Comparator group

Description:

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.

Treatment:

Behavioral: Biofeedback Training