FibromyalgiaFMMusicNCT04059042
Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
A study testing Music Listening in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the 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
- Conditions
- Fibromyalgia
- Being tested
- Music Listening
- Keywords
- Pain, Music, Analgesia
- Medical subject headings
- Fibromyalgia, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningBehavioural
Participants will have pain threshold testing while listening to silence, music, or nature sounds.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start13 Dec 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Why it stopped: Research activities suspended March 2020 due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Lepping, Ph.D., University of Kansas Medical Center
- Investigators
- Rebecca J Lepping, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059042
- Sponsor's protocol ID
- STUDY00144158
- Acronym
- FMMusic
- Status last verified
- Mar 2023
- First submitted
- 13 Aug 2019
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
- ClinicalTrials.gov ID
- NCT04059042
- Acronym / sponsor ID
- FMMusic / STUDY00144158
- Conditions
- Fibromyalgia
- Keywords
- Pain, Music, Analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research activities suspended March 2020 due to COVID-19 pandemic.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Behavioral: Music ListeningThe 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. |
| Nature Sounds | Placebo comparator | Behavioral: Music ListeningThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ListeningParticipants will have pain threshold testing while listening to silence, music, or nature sounds. | Behavioural | Music, Nature Sounds |
Primary outcome
Pain Threshold Summation
Time frame: 1 week
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.
Pain Tolerance
Time frame: 1 week
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Open Science Framework RegistrationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca J Lepping, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Threshold Summation (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.