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Examining the Effects of Processed Music on Chronic Pain

This study is currently recruiting participants.
Verified August 2017 by Stephen Porges, Indiana University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03083977
First Posted: March 20, 2017
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephen Porges, Indiana University
  Purpose

Chronic pain is a common ailment in aging populations and often co-occurs with altered regulation of the autonomic nervous system. Nociceptive pathways (i.e., those that transmit pain signals) are integrated with autonomic circuits throughout the body and therapies that are successful in reducing pain concurrently alter autonomic functions, even when they are not directly designed to do so. It is possible that interventions that target the autonomic circuits that regulate pain responses may help reduce pain in chronic pain sufferers. The proposed study will examine whether an intervention that targets the autonomic nervous system via filtered music can reduce pain, a hypothesis derived from the Polyvagal Theory.

The Polyvagal Theory describes how function and structure of the vertebrate autonomic nervous system changed during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. An evolutionary "old" branch of this nerve innervates structures below the diaphragm and its dysfunction is linked to lower body organ and tissue pain. Regulation of the vagus nerve is linked with specific auditory cues based on our evolutionary heritage and the physics of the middle ear. This study is designed to test whether processed music designed to stimulate vagal function can decrease chronic pain. The Listening Project Protocol, the processed music used in this intervention, has previously been shown to effectively stimulate the function of the vagus nerve (see stimulus description below).

Specific Aims:

Aim I: To examine whether The Listening Project Protocol, a non-invasive audio intervention, can be effective for reducing chronic pain in a sample of older adults.

Hypothesis: Five 1-hour sessions of the Listening Project Protocol will reduce pain

Aim II: To examine whether increased regulation via the autonomic nervous system accounts for the decrease in pain if the intervention is successful.

Hypothesis: Pain reduction will coincide with improved autonomic function by the myelinated vagus nerve (measured by respiratory sinus arrhythmia, see below) as well as decrease in the reactivity of autonomic functions in everyday experiences (measured by the Body Perception Questionnaire, see below)


Condition Intervention
Pain Other: Safe and Sound Protocol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Effects of Processed Music on Chronic Pain

Resource links provided by NLM:


Further study details as provided by Stephen Porges, Indiana University:

Primary Outcome Measures:
  • Pain [ Time Frame: Change over 1 week ]
    Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form

  • Pain [ Time Frame: Change over 1 week ]
    Change in intensity of pain from pre-assessment to post-assessment, measured by the McGill Pain Questionnaire Short Form


Secondary Outcome Measures:
  • Autonomic Function [ Time Frame: Change over 1 week ]
    Amplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart

  • Body perception [ Time Frame: Change over 1 week ]
    Autonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form


Other Outcome Measures:
  • Auditory processing [ Time Frame: Change over 1 week ]
    Auditory speech processing measured by ability to extract speech from background noise and understand speech with frequencies removed; measured by the SCAN Test for Auditory Processing Disorders (Keith, 2000)


Estimated Enrollment: 40
Actual Study Start Date: June 22, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
This group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days
Other: Safe and Sound Protocol
The intervention features music processed based on the resonating frequencies of the middle ear

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must self-report as suffering from chronic pain

Exclusion Criteria:

  • Individuals who do not read or speak proficient English
  • Individuals with substantial, uncorrected hearing loss
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083977


Contacts
Contact: Jacek Kolacz, PhD (812) 855-7686 jkolacz@iu.edu
Contact: Peter Miksza, PhD 812-855-7253 pmiksza@indiana.edu

Locations
United States, Indiana
Meadowood Retirement Community Recruiting
Bloomington, Indiana, United States, 47408
Contact: Mary Boutain    812-336-7060    MBOUTAIN@5ssl.com   
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Stephen Porges, PhD Indiana University
Study Chair: Peter Miksza, PhD Indiana University
Study Chair: Hannah Fidler Indiana University
Study Chair: Jacek Kolacz, PhD Indiana University
  More Information

Responsible Party: Stephen Porges, Distinguished University Scientist, Indiana University
ClinicalTrials.gov Identifier: NCT03083977     History of Changes
Other Study ID Numbers: 1702490842
First Submitted: March 8, 2017
First Posted: March 20, 2017
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms