PainNCT03692247
The Impact of Music Therapy on Nociceptive Processing
A study testing Smartphone-based Music Intervention in people with Pain and Chronic Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic Pain
- What is being tested?
- Smartphone-based Music Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 18 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Able to sign English written consent
- No history of chronic opioid use (have an opioid prescription more than 30 days).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Brookline, Massachusetts, 02115
About this study
Official title: Quantitative Sensory Testing in Response to Music Interventions
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.
Read the 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.
- Conditions
- Pain, Chronic Pain
- Being tested
- Smartphone-based Music Intervention
- Keywords
- pain, music
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based Music InterventionOther
The smartphone-based music intervention (Unwind) is a music protocol that gathers basic information from the patient including a 0-10 pain scale and 0-10 anxiety scale as well as recorded heart rate. Using these variables, a machine learning protocol pieces together a music intervention between 5-20 minutes long. The duration of the intervention can be controlled by the patient or experimenter. No identifying data is kept on the smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Quantitative Sensory Testing | Other | After answering brief questionnaires assessing psychosocial factors related to anxiety, catastrophizing, and pain, participants will undergo quantitative sensory tests where they will use a simple numeric rating scale (0-10) to rate pain and anxiety at several points during two QST sessions. During the second QST session, participants will use Unwind, a smartphone-based music intervention. Receives: Other: Smartphone-based Music Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Sensitivity in the Presence of Music
Change in pain sensitivity, measured as a difference in the temporal summation of pain with a mechanical stimulus between a control and music condition of testing.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start7 Jun 2018
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a cohort study of one group of 60 healthy volunteers without a diagnosis of neuropathy or chronic pain.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward W Boyer, Brigham and Women's Hospital
- Investigators
- Edward Boyer, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692247
- Sponsor's protocol ID
- 2017P002872
- Status last verified
- Jan 2019
- First submitted
- 16 Jun 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- 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 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing in Response to Music Interventions
- ClinicalTrials.gov ID
- NCT03692247
- Acronym / sponsor ID
- 2017P002872
- Conditions
- Pain, Chronic Pain
- Keywords
- pain, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a cohort study of one group of 60 healthy volunteers without a diagnosis of neuropathy or chronic pain.
| Arm | Type | Receives |
|---|---|---|
| Quantitative Sensory Testing | Other | Other: Smartphone-based Music InterventionAfter answering brief questionnaires assessing psychosocial factors related to anxiety, catastrophizing, and pain, participants will undergo quantitative sensory tests where they will use a simple numeric rating scale (0-10) to rate pain and anxiety at several points during two QST sessions. During the second QST session, participants will use Unwind, a smartphone-based music intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Able to sign English written consent
- No history of chronic opioid use (have an opioid prescription more than 30 days).
Key exclusion criteria (6 listed)
- Under 18 years old
- Non-English speaking
- Unwilling to undergo quantitative sensory testing
- Hearing loss
- Diagnosis of neuropathy
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 |
|---|---|---|
| Smartphone-based Music InterventionThe smartphone-based music intervention (Unwind) is a music protocol that gathers basic information from the patient including a 0-10 pain scale and 0-10 anxiety scale as well as recorded heart rate. Using these variables, a machine learning protocol pieces together a music intervention between 5-20 minutes long. The duration of the intervention can be controlled by the patient or experimenter. No identifying data is kept on the smartphone. | Other | Quantitative Sensory Testing |
Primary outcome
Changes in Pain Sensitivity in the Presence of Music
Time frame: 40 minutes
Change in pain sensitivity, measured as a difference in the temporal summation of pain with a mechanical stimulus between a control and music condition of testing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- 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.
Edward Boyer, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based Music Intervention in people with Pain and Chronic Pain, run by Brigham and Women's Hospital 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 30 Jan 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Pain Sensitivity in the Presence of Music (time frame: 40 minutes). 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 30 Jan 2019.