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Biofeedback Training to Control Pain Processing

Biofeedback Training to Control Pain Processing

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02752386
Enrollment
94
Registered
2016-04-27
Start date
2016-02-29
Completion date
2018-07-31
Last updated
2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

BEHAVIORALBiofeedback Training

Participants will received biofeedback training to reduce arousal and pain

Sponsors

University of Tulsa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in nociceptive flexion reflex thresholdAssessed at the beginning and end of each of the 3 biofeedback training daysphysiological marker of pain processing
Change in temporal summation of painAssessed at the beginning and end of each of the 3 biofeedback training daysmarker of pain facilitation (change in pain rating 0-100 that occurs in response to a mechanical stimulus series)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026