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Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia (FMMusic)

Primary Purpose

Fibromyalgia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Listening
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia focused on measuring Pain, Music, Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to read and speak English to allow for written informed consent, phenotyping, and patient- reported outcomes measures
  • Willingness to refrain from alcohol and nicotine on day of QST
  • Willingness to refrain from physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable)
  • The investigators will attempt to recruit individuals with no chronic daily use of adjunctive pain medications, including tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and gabapentinoids as these drugs can influence QST findings, or have individuals be weaned off of these meds at least two weeks prior to being studied. If the investigators do need to allow individuals into these cohorts while on such medications because of pragmatic issues, this information will be recorded and patients will be asked to remain on a stable dose for at least two weeks prior to QST assessments.

Exclusion Criteria:

  • Individuals receiving or applying for compensation or disability and other aspects associated with potential secondary gain
  • Inability to provide written informed consent
  • Peripheral neuropathy or loss of sensation in the upper or lower extremities which would preclude QST testing
  • Severe physical impairment (e.g., blindness, deafness, paraplegia)
  • Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non- skin malignancy, or autoimmune disorder)
  • Illicit drug or unreported opioid use (unreported opioid use would be considered opioid abuse and thereby excluded)
  • Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., malignancy, psychosis, suicidal ideation)
  • Pregnant or nursing
  • Liver failure
  • Self-reported liver cirrhosis
  • Self-reported hepatitis
  • Severe Cardiovascular disease (examples: history of myocardial infarction, unstable angina, severe coronary artery disease, congestive heart failure, or severe valvular abnormalities) that are self-reported by patient or by medical record
  • Average daily opioid dosing of >15 mg oral morphine equivalents preoperatively (e.g., > two 5 mg oxycodone tablets/day or > three 5 mg hydrocodone tablets/day). Conversions will be made based on well-accepted conversion tools used previously. The rationale to include some patients taking low dose opioids is to enhance the generalizability of the findings (opioids are common in patients with many pain states), while not causing confounding by including patients on very high doses of opioids which may be a cause of opioid induced hyperalgesia which closely resembles central sensitization

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Music

Nature Sounds

Arm Description

The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear music. The musical selections will be professional recordings of instrumental Classical music selected by the researcher. All participants will hear the same pieces in the same order. Instrumentation ranges from piano solo to full orchestra, but they are without lyrics or heavy percussion. Pitch ranges across the pieces, but is standard across participants and not controlled by either the participant or the researcher. Tempo for all of the pieces is slow (~60 beats per minute). The pieces are in either major keys or minor keys, but all consist primarily of consonant harmonies and sustained melodic phrases. Participants will control the volume to their individual comfort level.

The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear nature sounds. Professional recordings of nature sounds selected by the researcher without added music will be used as the active placebo control condition. All participants will hear the same recording. This active control condition will allow for non-musical analgesic effects, such as distraction, to be controlled in the experimental design. Participants will control the volume to their individual comfort level.

Outcomes

Primary Outcome Measures

Pain threshold
Pain threshold as measured by the quantitative sensory testing (QST) battery.
Pain tolerance
Pain tolerance as measured by the quantitative sensory testing (QST) battery.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2019
Last Updated
April 26, 2021
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04059042
Brief Title
Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
Acronym
FMMusic
Official Title
Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Research activities suspended March 2020 due to COVID-19 pandemic.
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with fibromyalgia (FM) are more sensitive to things that cause pain. Music lowers self-reported pain in patients with chronic pain. The investigators are able to measure pain sensitivity and pain tolerance using tools that cause pain and give accurate measurements of how much pressure is put on the body (QST). Previous studies have shown that after a few minutes of listening to music patients with FM have less self-reported pain, can get up and move from sitting more quickly, and have more activity in part of the brain that tells the body to stop sending pain signals. The investigators will study 40 patients with FM using the QST tools. All patients will have testing done as usual, with no sound. Then half of the patients will have testing done while listening to instrumental Classical music, and the other half will have testing done while listening to nature sounds. The investigators will test 1) whether listening to anything lessens pain compared to listening to nothing at all; and 2) whether listening to music lessens pain more than listening to nature sounds. Our study will be the first to study whether objectively measured pain sensitivity is less while listening to music in these patients.
Detailed Description
Fibromyalgia can be thought of as a centralized pain state where pain is manifested and experienced in different body regions at different times. Individuals with centralized pain feel more pain than would be normally expected based on the level of nociceptive input. Music has previously been shown to have a positive effect on pain, anxiety, and depression in chronic pain patients. However, the impact of music listening on objective measures of pain sensitivity in patients with chronic pain have not yet been described. The goal of this pilot study is to begin to understand the possible analgesic effects of music listening on objective measures of pain sensitivity in patients with fibromyalgia. Previous studies in patients with FM have shown that patients have reduced self-reported pain, increased mobility, and activation of the descending pain modulatory system in the brain after even a short, 5 to10-minute music listening intervention. Our proposed study will be the first to investigate whether objectively measured pain sensitivity is reduced by music listening in these patients. This two-arm parallel randomized controlled pilot study will enroll 40 patients with fibromyalgia. Patients' pain thresholds and sensitivity will be measured using a battery of quantitative sensory tests (QST). All patients will have two testing sessions: one under testing as usual conditions with no-sound, and one while listening to either instrumental Classical music, selected by the researchers with careful consideration of the musical characteristics, or a nature sound placebo control condition. This careful experimental design will allow us to test whether music listening elicits greater analgesic effects over simple auditory distraction. To minimize potential bias the investigators will employ sound cancelling headphones and randomization of conditions so that the researcher collecting the QST measures will be blinded to whether the patient is hearing music, nature sounds, or nothing. The proposed study is significant as it will identify whether music listening has an analgesic effect during pain threshold and tolerance testing for patients with FM that supercedes any effect of auditory distraction. Results from the proposed study may provide objective evidence that music listening objectively improves analgesia and pain management and thus could be considered therapeutic during situations where acute pain is expected

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Pain, Music, Analgesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm (Music, Nature Sounds) parallel randomized controlled pilot study in patients with fibromyalgia with between-subject counterbalanced repeated measure control (Silence). The primary outcome measure will be pain threshold and tolerance as measured by the quantitative sensory testing (QST) battery.
Masking
InvestigatorOutcomes Assessor
Masking Description
Personnel who interact directly with the study subjects (either human or non-human subjects) will not be aware of the assigned treatments. (Commonly known as "double blind") Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear music. The musical selections will be professional recordings of instrumental Classical music selected by the researcher. All participants will hear the same pieces in the same order. Instrumentation ranges from piano solo to full orchestra, but they are without lyrics or heavy percussion. Pitch ranges across the pieces, but is standard across participants and not controlled by either the participant or the researcher. Tempo for all of the pieces is slow (~60 beats per minute). The pieces are in either major keys or minor keys, but all consist primarily of consonant harmonies and sustained melodic phrases. Participants will control the volume to their individual comfort level.
Arm Title
Nature Sounds
Arm Type
Placebo Comparator
Arm Description
The investigators will manipulate the audio environment the participant experiences 10 minutes before and throughout pain threshold testing (~1 hour). All participants will have one testing session with silence (testing as usual control). On the other testing session, participants will hear nature sounds. Professional recordings of nature sounds selected by the researcher without added music will be used as the active placebo control condition. All participants will hear the same recording. This active control condition will allow for non-musical analgesic effects, such as distraction, to be controlled in the experimental design. Participants will control the volume to their individual comfort level.
Intervention Type
Behavioral
Intervention Name(s)
Music Listening
Intervention Description
Participants will have pain threshold testing while listening to silence, music, or nature sounds.
Primary Outcome Measure Information:
Title
Pain threshold
Description
Pain threshold as measured by the quantitative sensory testing (QST) battery.
Time Frame
1 week
Title
Pain tolerance
Description
Pain tolerance as measured by the quantitative sensory testing (QST) battery.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to read and speak English to allow for written informed consent, phenotyping, and patient- reported outcomes measures Willingness to refrain from alcohol and nicotine on day of QST Willingness to refrain from physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable) The investigators will attempt to recruit individuals with no chronic daily use of adjunctive pain medications, including tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and gabapentinoids as these drugs can influence QST findings, or have individuals be weaned off of these meds at least two weeks prior to being studied. If the investigators do need to allow individuals into these cohorts while on such medications because of pragmatic issues, this information will be recorded and patients will be asked to remain on a stable dose for at least two weeks prior to QST assessments. Exclusion Criteria: Individuals receiving or applying for compensation or disability and other aspects associated with potential secondary gain Inability to provide written informed consent Peripheral neuropathy or loss of sensation in the upper or lower extremities which would preclude QST testing Severe physical impairment (e.g., blindness, deafness, paraplegia) Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non- skin malignancy, or autoimmune disorder) Illicit drug or unreported opioid use (unreported opioid use would be considered opioid abuse and thereby excluded) Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., malignancy, psychosis, suicidal ideation) Pregnant or nursing Liver failure Self-reported liver cirrhosis Self-reported hepatitis Severe Cardiovascular disease (examples: history of myocardial infarction, unstable angina, severe coronary artery disease, congestive heart failure, or severe valvular abnormalities) that are self-reported by patient or by medical record Average daily opioid dosing of >15 mg oral morphine equivalents preoperatively (e.g., > two 5 mg oxycodone tablets/day or > three 5 mg hydrocodone tablets/day). Conversions will be made based on well-accepted conversion tools used previously. The rationale to include some patients taking low dose opioids is to enhance the generalizability of the findings (opioids are common in patients with many pain states), while not causing confounding by including patients on very high doses of opioids which may be a cause of opioid induced hyperalgesia which closely resembles central sensitization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca J Lepping, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://osf.io/84baz
Description
Open Science Framework Registration

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Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia

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