The Impact of Music Therapy on Nociceptive Processing

• ClinicalTrials.gov Identifier: NCT03692247
• Recruitment Status: Completed
• First Posted: October 2, 2018
• Last Update Posted: January 30, 2019
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Edward W Boyer, Brigham and Women's Hospital

Study Description

Brief Summary:

The purpose of this study is to understand the use of brief, personalized music interventions to decrease pain. Persisting and recurring pain is devastating to individuals and society. The worry and anxiety people feel while experiencing chronic pain may increase how much pain they feel. Enjoyable music feels good and affects brain chemicals in a way that can lessen feelings of pain. Music that feels good can also lower the anxiety and worry that accompany chronic pain which may play a role in the pain relief music provides.

Condition or disease	Intervention/treatment	Phase
Pain; Chronic Pain	Other: Smartphone-based Music Intervention	Not Applicable

Detailed Description:

Chronic pain is devastating to individuals and society. Individuals who experience chronic pain have poorer health outcomes, utilize increased healthcare resources and have higher rates of disability. At present, treatment of chronic pain is limited to behavioral interventions and pharmacologic interventions. Many individuals with chronic pain will use opioid analgesics at some point in the continuum of pain. Prolonged use of opioid analgesics--even for durations as short as 3 days puts individuals at risk for nonmedical opioid use, addiction, and may fuel transitions from oral opioids to heroin.

Outside of the original insult precipitating chronic pain, increasing evidence suggests that individual factors such as anxiety and catastrophizing are associated with development of chronic pain and increased painful response to stimuli. It is therefore suggestive that treating underlying causes of anxiety and catastrophizing may lead to novel adjunctive therapies to manage chronic pain.

Music is emotive and known to modulate affect. Music that "feels good" has been described to modulate the dopaminergic and serotonin reward pathways in the brain thereby improving positive affect. Improved affect counteracts negatively valenced affect like depression, anxiety, and catastrophizing, and may be able to modulate the individual response to pain. The purpose of this pilot study is to investigate the acceptability and feasibility of a smartphone-based app on healthy volunteers.

In order to measure the impact of the music app on individual responses to pain, the investigators will use quantitative sensory testing (QST) to induce a mild-moderate, standardized pain stimulus, and measure participants' pain in the absence and presence of this music intervention. The QST is a 10 minute session that includes a set of sensory tests, which elicit a mild to moderate painful response, including a pressure pain threshold and tolerance using a handheld digital algometer, the temporal summation of pain using a set of weighted pinprick probes, and immersing hand in cold water. Primary outcome will be the modulation of pain scores by music, and secondary outcomes will include the impact of music on anxiety and catastrophizing, using brief, validated questionnaires, and whether changes in these measures of affect mediate any impact on pain processing.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a cohort study of one group of 60 healthy volunteers without a diagnosis of neuropathy or chronic pain.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Quantitative Sensory Testing in Response to Music Interventions
• Actual Study Start Date: June 7, 2018
• Actual Primary Completion Date: July 18, 2018
• Actual Study Completion Date: July 18, 2018

Arms and Interventions

Arm

Intervention/treatment

Quantitative Sensory Testing; After answering brief questionnaires assessing psychosocial factors related to anxiety, catastrophizing, and pain, participants will undergo quantitative sensory tests where they will use a simple numeric rating scale (0-10) to rate pain and anxiety at several points during two QST sessions. During the second QST session, participants will use Unwind, a smartphone-based music intervention.

Other: Smartphone-based Music Intervention; The smartphone-based music intervention (Unwind) is a music protocol that gathers basic information from the patient including a 0-10 pain scale and 0-10 anxiety scale as well as recorded heart rate. Using these variables, a machine learning protocol pieces together a music intervention between 5-20 minutes long. The duration of the intervention can be controlled by the patient or experimenter. No identifying data is kept on the smartphone.

Outcome Measures

Primary Outcome Measures :

1. Changes in Pain Sensitivity in the Presence of Music [ Time Frame: 40 minutes ]
   Change in pain sensitivity, measured as a difference in the temporal summation of pain with a mechanical stimulus between a control and music condition of testing.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Over 18 years old
• Able to sign English written consent
• No history of chronic opioid use (have an opioid prescription more than 30 days).

Exclusion Criteria:

• Under 18 years old
• Non-English speaking
• Unwilling to undergo quantitative sensory testing
• Hearing loss
• Diagnosis of neuropathy
• History of chronic opioid use (having an opioid prescription more than 30 days).

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Brookline, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

• Principal Investigator: Edward Boyer, MD, PhD; Brigham and Women's Hospital

More Information

• Responsible Party: Edward W Boyer, Director of Academic Development, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03692247
• Other Study ID Numbers: 2017P002872
• First Posted: October 2, 2018
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

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

Keywords provided by Edward W Boyer, Brigham and Women's Hospital:

pain; music

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations