Biofeedback Training to Control Pain Processing

Pain Clinical Trial

Official title:

Biofeedback Training to Control Pain Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752386
• Other study ID #: TU1560
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: September 2019
• Source: University of Tulsa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 31, 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Biofeedback Training
Participants will received biofeedback training to reduce arousal and pain

Locations

Country	Name	City	State
United States	University of Tulsa	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nociceptive flexion reflex threshold	physiological marker of pain processing	Assessed at the beginning and end of each of the 3 biofeedback training days
Primary	Change in temporal summation of pain	marker of pain facilitation (change in pain rating 0-100 that occurs in response to a mechanical stimulus series)	Assessed at the beginning and end of each of the 3 biofeedback training days