Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia

NCT04059042 | Terminated Results

• 1 other identifier: STUDY00144158
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Pain; Music; Analgesia

Outcome Measures

Primary Outcomes (2)

• Pain Threshold Summation

  Pain threshold summation as measured by the quantitative sensory testing (QST) battery. Pain is rated subjectively on a 0-100 scale with 0 being no pain and 100 being the worst pain imaginable. Summation is calculated as the difference in pain score between a single stimulus and a series of 10 stimuli with larger values indicating more severe summation.

  1 week

• Pain Tolerance

  Pain tolerance as measured by the quantitative sensory testing (QST) battery. Pain is rated subjectively on a 0-100 scale with 0 being no pain and 100 being the worst pain imaginable. Tolerance is the pressure (kg/cm2) at which participants rated pain in their non-dominant thumb at 70 out of 100.

  1 week

Study Arms (2)

Music

EXPERIMENTAL

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.

Behavioral: Music Listening

Nature Sounds

PLACEBO COMPARATOR

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.

Behavioral: Music Listening

Interventions

Music Listening BEHAVIORAL

Participants will have pain threshold testing while listening to silence, music, or nature sounds.

Music; Nature Sounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Links

• Open Science Framework Registration

MeSH Terms

Conditions

Fibromyalgia; Pain; Agnosia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Limitations and Caveats

Early termination leading to small numbers of participants analyzed

Results Point of Contact

• Title: Dr. Rebecca Lepping
• Organization: University of Kansas Medical Center

rlepping@kumc.edu

913-588-0287

Study Officials

• Rebecca J Lepping, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 16, 2019
• Study Start: December 13, 2019
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)