Clinical trial NCT04087564: The Impact of Music on Nociceptive Processing
Official title: Investigating Differences in Modulation of Nociceptive Processing by Music in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Pain, Chronic
Anxiety
Anxiety Disorders
Catastrophization
Healthy
Keywords: Music
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each subject serves as their own control
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are studying the ways that different music may change pain perception

Detailed description: In this study, the investigators are comparing healthy individuals to HIV and Fibromyalgia patients. The investigators are measuring the differences in pain processing between subject groups in the presence and absence of different music and distraction conditions. The investigators will be using Quantitative Sensory Testing (QST) in order to induce varying pain conditions on the participants. The investigators will also have participants complete sets of psychosocial questionnaires. Patients with Fibromyalgia tend to have a higher pain sensitivity. Additionally, patients with an HIV diagnosis tend to be prescribed opioid medications. The investigators would like to find out if music can modulate pain, and in turn help reduce the amount of opioid medications those with a chronic pain diagnosis take.

Eligibility criteria: Healthy volunteers no longer needed for this study (9/9/2021).

Inclusion criteria for Healthy volunteers (N=70) without a diagnosis of neuropathy or chronic pain:

* aged \>18 years
* able to speak and understand English
* willingness to undergo psychophysical and psychosocial testing.

Exclusion criteria:

* diagnosed hearing loss
* diagnosis of chronic pain/neuropathy
* history of chronic opioid use (having an opioid prescription \>30 days).

Inclusion criteria for Fibromyalgia patients: N=70:

* aged \>18 years
* have a diagnosis of fibromyalgia with concurrent chronic pain for \> 6 months, and meet the Wolfe et al 2011 research criteria for fibromyalgia
* have an average self-reported pain score of 4/10 or greater
* willing to undergo psychophysical and psychosocial testing
* able to speak and understand English.

Exclusion criteria:

--diagnosed hearing loss.

HIV Patients with chronic pain: N=70

* aged \>18- years
* have a diagnosis of HIV infection
* have had chronic pain with onset \> 6 months
* have an average self-reported pain score of 4/10 or greater
* willing to undergo psychophysical and psychosocial testing
* able speak and understand English.

Exclusion criteria:

--diagnosed hearing loss.

Primary outcomes:
measure: Modulation of Pressure Pain Threshold/Tolerance
timeFrame: 15 minutes
measure: Modulation of Temporal Summation with Repeated Pinpricks
timeFrame: 15 minutes
measure: Modulation of Temporal Summation with Pressure Cuff
timeFrame: 15 minutes
measure: Modulation of Heat Pain Threshold and Tolerance
timeFrame: 15 minutes
measure: Modulation of Heat Offset Analgesia
timeFrame: 15 minutes
measure: Modulation of Conditioned Pain Modulation
timeFrame: 15 minutes
measure: Modulation of Anxiety
timeFrame: 10 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kristin L Schreiber, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: