Clinical trial NCT03692247: The Impact of Music Therapy on Nociceptive Processing
Official title: Quantitative Sensory Testing in Response to Music Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Chronic Pain
Keywords: pain
music
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a cohort study of one group of 60 healthy volunteers without a diagnosis of neuropathy or chronic pain.
Primary purpose: OTHER

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.

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.

Eligibility 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).

Primary outcomes:
measure: Changes in Pain Sensitivity in the Presence of Music
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brookline
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Edward Boyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: