Clinical trial NCT02752386: Biofeedback Training to Control Pain Processing
Official title: Biofeedback Training to Control Pain Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Tulsa
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in nociceptive flexion reflex threshold
timeFrame: Assessed at the beginning and end of each of the 3 biofeedback training days
measure: Change in temporal summation of pain
timeFrame: Assessed at the beginning and end of each of the 3 biofeedback training days
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Tulsa
state: Oklahoma
Study officials:
affiliation: The University of Tulsa
name: Jamie L Rhudy, PhD
role: PRINCIPAL_INVESTIGATOR
References: