Pain, AcuteNCT04087564
The Impact of Music on Nociceptive Processing
A study testing music intervention in people with Pain, Acute and Pain, Chronic, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The investigators are studying the ways that different music may change pain perception Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Pain, Chronic, Anxiety
- What is being tested?
- music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 23 May 2023
- 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
- 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.
Who cannot join
- diagnosed hearing loss
- diagnosis of chronic pain/neuropathy
- history of chronic opioid use (having an opioid prescription >30 days).
- --diagnosed hearing loss.
- HIV Patients with chronic pain: N=70
- aged >18- years
Show all 12Show fewer
- 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.
- --diagnosed hearing loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02155
About this study
Official title: Investigating Differences in Modulation of Nociceptive Processing by Music in Chronic Pain Patients
The investigators are studying the ways that different music may change pain perception
Read the 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.
- Conditions
- Pain, Acute, Pain, Chronic, Anxiety, Anxiety Disorders, Catastrophization, Healthy
- Being tested
- music intervention
- Keywords
- Music
- Medical subject headings
- Acute Pain, Chronic Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music interventionOther
Also called Unwind, Favorite Music, White Noise
The music intervention (Unwind), developed by the investigators collaborators at the Sync Project, is a machine learning protocol that generates specific sounds and phrases of music that are stitched into a music track in response to user-reported pain, anxiety and catastrophizing scales. Unwind is delivered via a web application on a smart phone.
Participants will also listen to white noise and their favorite music throughout the study session
| Study group | Role | What they receive |
|---|---|---|
| music intervention | Experimental | Healthy volunteers, and patients diagnosed with HIV or fibromyalgia will complete 4 rounds of QST testing; baseline + 3 music conditions to determine effect of music on pain sensitivity. Receives: Other: music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of Pressure Pain Threshold/Tolerance
Pressure algometry is the most commonly used test for static mechanical pressure sensation in the skin and in deep tissues. Pressure algometers deliver a firm and quantifiable pressure through a flat base applied to the skin. The electronic pressure algometer that we will use (Wagner Instruments) is a hand-held algometer utilizing a pressure-sensitive strain gauge, covered by a 0.5 cm2 circular probe. The probe is covered with a soft polypropylene disk, to avoid injury to the skin. The pressure applied through the probe is transduced, amplified, and converted to electrical reading on a digital display. The pressure will be slowly increased (1 lb/s) and the participant will be asked to note when they first feel pain and when they want the pressure to stop , which will be recorded as the pressure pain threshold and tolerance, respectively. This process will be repeated on the trapezius and the forearm, alternating between sides of the body with 20 seconds between measurements.
Measured: 15 minutes
Modulation of Temporal Summation with Repeated Pinpricks
Will be assessed using standardized weighted pinprick applicators using a range of forces (128 mN, 256mN and 512mN) which result in a painful sensation in most subjects. First, a single stimulation of the lower force pinprick will be applied to the dorsal aspect of the index finger between the first and second interphalangeal joints of each hand while resting palm down on the armrest, and then rated by the subject on a scale of 0-10. The weight probe that induces at least some pain, but not more than 3/10 pain will be determined, and this probe used for repeated testing. Then, a train of 10 stimuli will be applied at the same spot, at a rate of 1 stimulation/second. The subject will rate pain on a scale of 0-10 after the first, fifth and tenth stimulus, then rate any ongoing pain 15 seconds after cessation of the last stimulus (painful after-sensations). Temporal summation will be calculated as the change in pain score between the highest and lowest pain ratings in a train.
Measured: 15 minutes
Modulation of Temporal Summation with Pressure Cuff
Will be assessed through response to cuff pressure algometry (CPA), in a similar manner to our previous studies.123 Tonic, deep-tissue, mechanical stimulation will be applied using a rapid cuff inflator (Hokanson) wrapped around the leg, centered around the middle of the gastrocnemius muscle. Pressure will then be increased at approximately 5-10 mmHg/s, at which time participants will be asked to note when they first start feeling pain and then when they feel as though the pain is a 5/10. At this point the cuff will be deflated. Participants will be given a 30 second break. The cuff will be re-inflated to this previously identified pressure and held for two minutes (or until participant asks to stop), at which point the cuff will be deflated. Participants will be asked to rate their pain every 30 seconds, as well as to rate any painful after sensations. Temporal summation will be calculated as the change in pain score between the highest and lowest pain ratings in the 2 minutes.
Measured: 15 minutes
Modulation of Heat Pain Threshold and Tolerance
Heat pain responses will be assessed using a contact thermode, which delivers heat stimuli through a computer-controlled system (Medoc). The contact probe will be positioned on the skin and affixed in place on the volar aspect of the non-dominant forearm with a soft Velcro strap, after which an ascending method of limits paradigm will be employed, using a rate of rise of 2°C/sec, starting at a baseline of 35°C. For heat pain threshold, subjects are instructed to press a button when the thermal stimulation first becomes painful; pressing the button returns the thermode temperature to 35°C. Then the thermode will again increase in temperature, and this time the conductor will ask the participant to press the button when the thermal stimulation reaches 5/10 pain, which will return the thermode temperature to 35°C.
Measured: 15 minutes
Modulation of Heat Offset Analgesia
In order to measure offset analgesia the thermode will be ramped up to a temperature that is 1 degree less than the temperature that they indicated produced 5/10 pain. The temperature will be held for 5 seconds and the participant will be asked to provide a pain rating from 0-10 at the timepoint approximately 2 seconds into the 5 second period. Then the temperature will ramp up 1 degree higher (to the patient's 5/10 temperature) and held for 5 seconds. The participant will be asked to provide a pain rating from 0-10 at the timepoint approximately 2 seconds into the 5 second period. Then the temperature will return back to 1 degree lower, be held here for 5 seconds, and the participant will be asked to provide a pain rating from 0-10 at the timepoint approximately 2 seconds into the 5 second period. Lastly, the thermode will return to baseline temperature, and be removed from the forearm. The conductor will ask for pain scores every 7 seconds for 21 seconds seconds(aftersensations).
Measured: 15 minutes
Modulation of Conditioned Pain Modulation
CPM will be measured by adaptations of testing procedures used in our previous studies.
To measure CPM, pressure pain threshold and tolerance as measured earlier in the session will be compared to measurement in the presence of a conditioning stimulus (cold pain in hand). The participant will be asked to submerge their right hand (up to above the wrist) into a cold-water bath set at 6°C. Approximately 5 seconds after placing hand in cold water bath, a constant, increasing pressure (1lb/s) will again be applied to the contralateral trapezius with participant indicating when they start to feel pain (threshold) and when they want pressure to stop (tolerance). CPM defined as: CPM=((pressure pain in presence- pressure pain in absence of cold pain)/pressure pain in absence of cold pain)*100). Participants then asked to describe their worst cold pain, clinical pain, anxiety rating about testing and about the cold-water bath specifically, and if they experience any painful after sensations.
Measured: 15 minutes
Modulation of Anxiety
Question assessing how much anxiety felt during session, using Likert Scale (0-10), with 0 being no anxiety and 10 being extremely anxious.
Measured: 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start13 Jun 2019
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subject serves as their own control
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Schreiber, Brigham and Women's Hospital
- Investigators
- Kristin L Schreiber, MD PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087564
- Sponsor's protocol ID
- 2019P000824
- Status last verified
- May 2023
- First submitted
- 13 Nov 2017
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wilson JM, Franqueiro AR, Edwards RR, Chai PR, Schreiber KL. Individuals with fibromyalgia report greater pain sensitivity than healthy adults while listening to their favorite music: the contribution of negative affect. Pain Med. 2024 May 2;25(5):352-361. doi: 10.1093/pm/pnae005.
PubMed 38291916Colebaugh CA, Wilson JM, Flowers KM, Overstreet D, Wang D, Edwards RR, Chai PR, Schreiber KL. The Impact of Varied Music Applications on Pain Perception and Situational Pain Catastrophizing. J Pain. 2023 Jul;24(7):1181-1192. doi: 10.1016/j.jpain.2023.01.006. Epub 2023 Jan 14.
PubMed 36646399
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Differences in Modulation of Nociceptive Processing by Music in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT04087564
- Acronym / sponsor ID
- 2019P000824
- Conditions
- Pain, Acute, Pain, Chronic, Anxiety, Anxiety Disorders, Catastrophization, Healthy
- Keywords
- Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 12 Sep 2019 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subject serves as their own control
| Arm | Type | Receives |
|---|---|---|
| music intervention | Experimental | Other: music interventionHealthy volunteers, and patients diagnosed with HIV or fibromyalgia will complete 4 rounds of QST testing; baseline + 3 music conditions to determine effect of music on pain sensitivity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- diagnosed hearing loss
- diagnosis of chronic pain/neuropathy
- history of chronic opioid use (having an opioid prescription >30 days).
- --diagnosed hearing loss.
- HIV Patients with chronic pain: N=70
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 interventionAlso: Unwind, Favorite Music, White NoiseThe music intervention (Unwind), developed by the investigators collaborators at the Sync Project, is a machine learning protocol that generates specific sounds and phrases of music that are stitched into a music track in response to user-reported pain, anxiety and catastrophizing scales. Unwind is delivered via a web application on a smart phone. Participants will also listen to white noise and their favorite music throughout the study session | Other | music intervention |
Primary outcome
Modulation of Pressure Pain Threshold/Tolerance
Time frame: 15 minutes
Pressure algometry is the most commonly used test for static mechanical pressure sensation in the skin and in deep tissues. Pressure algometers deliver a firm and quantifiable pressure through a flat base applied to the skin. The electronic pressure algometer that we will use (Wagner Instruments) is a hand-held algometer utilizing a pressure-sensitive strain gauge, covered by a 0.5 cm2 circular probe. The probe is covered with a soft polypropylene disk, to avoid injury to the skin. The pressure applied through the probe is transduced, amplified, and converted to electrical reading on a digital display. The pressure will be slowly increased (1 lb/s) and the participant will be asked to note when they first feel pain and when they want the pressure to stop , which will be recorded as the pressure pain threshold and tolerance, respectively. This process will be repeated on the trapezius and the forearm, alternating between sides of the body with 20 seconds between measurements.
Modulation of Temporal Summation with Repeated Pinpricks
Time frame: 15 minutes
Will be assessed using standardized weighted pinprick applicators using a range of forces (128 mN, 256mN and 512mN) which result in a painful sensation in most subjects. First, a single stimulation of the lower force pinprick will be applied to the dorsal aspect of the index finger between the first and second interphalangeal joints of each hand while resting palm down on the armrest, and then rated by the subject on a scale of 0-10. The weight probe that induces at least some pain, but not more than 3/10 pain will be determined, and this probe used for repeated testing. Then, a train of 10 stimuli will be applied at the same spot, at a rate of 1 stimulation/second. The subject will rate pain on a scale of 0-10 after the first, fifth and tenth stimulus, then rate any ongoing pain 15 seconds after cessation of the last stimulus (painful after-sensations). Temporal summation will be calculated as the change in pain score between the highest and lowest pain ratings in a train.
Modulation of Temporal Summation with Pressure Cuff
Time frame: 15 minutes
Will be assessed through response to cuff pressure algometry (CPA), in a similar manner to our previous studies.123 Tonic, deep-tissue, mechanical stimulation will be applied using a rapid cuff inflator (Hokanson) wrapped around the leg, centered around the middle of the gastrocnemius muscle. Pressure will then be increased at approximately 5-10 mmHg/s, at which time participants will be asked to note when they first start feeling pain and then when they feel as though the pain is a 5/10. At this point the cuff will be deflated. Participants will be given a 30 second break. The cuff will be re-inflated to this previously identified pressure and held for two minutes (or until participant asks to stop), at which point the cuff will be deflated. Participants will be asked to rate their pain every 30 seconds, as well as to rate any painful after sensations. Temporal summation will be calculated as the change in pain score between the highest and lowest pain ratings in the 2 minutes.
Modulation of Heat Pain Threshold and Tolerance
Time frame: 15 minutes
Heat pain responses will be assessed using a contact thermode, which delivers heat stimuli through a computer-controlled system (Medoc). The contact probe will be positioned on the skin and affixed in place on the volar aspect of the non-dominant forearm with a soft Velcro strap, after which an ascending method of limits paradigm will be employed, using a rate of rise of 2°C/sec, starting at a baseline of 35°C. For heat pain threshold, subjects are instructed to press a button when the thermal stimulation first becomes painful; pressing the button returns the thermode temperature to 35°C. Then the thermode will again increase in temperature, and this time the conductor will ask the participant to press the button when the thermal stimulation reaches 5/10 pain, which will return the thermode temperature to 35°C.
Modulation of Heat Offset Analgesia
Time frame: 15 minutes
In order to measure offset analgesia the thermode will be ramped up to a temperature that is 1 degree less than the temperature that they indicated produced 5/10 pain. The temperature will be held for 5 seconds and the participant will be asked to provide a pain rating from 0-10 at the timepoint approximately 2 seconds into the 5 second period. Then the temperature will ramp up 1 degree higher (to the patient's 5/10 temperature) and held for 5 seconds. The participant will be asked to provide a pain rating from 0-10 at the timepoint approximately 2 seconds into the 5 second period. Then the temperature will return back to 1 degree lower, be held here for 5 seconds, and the participant will be asked to provide a pain rating from 0-10 at the timepoint approximately 2 seconds into the 5 second period. Lastly, the thermode will return to baseline temperature, and be removed from the forearm. The conductor will ask for pain scores every 7 seconds for 21 seconds seconds(aftersensations).
Modulation of Conditioned Pain Modulation
Time frame: 15 minutes
CPM will be measured by adaptations of testing procedures used in our previous studies. To measure CPM, pressure pain threshold and tolerance as measured earlier in the session will be compared to measurement in the presence of a conditioning stimulus (cold pain in hand). The participant will be asked to submerge their right hand (up to above the wrist) into a cold-water bath set at 6°C. Approximately 5 seconds after placing hand in cold water bath, a constant, increasing pressure (1lb/s) will again be applied to the contralateral trapezius with participant indicating when they start to feel pain (threshold) and when they want pressure to stop (tolerance). CPM defined as: CPM=((pressure pain in presence- pressure pain in absence of cold pain)/pressure pain in absence of cold pain)*100). Participants then asked to describe their worst cold pain, clinical pain, anxiety rating about testing and about the cold-water bath specifically, and if they experience any painful after sensations.
Modulation of Anxiety
Time frame: 10 Minutes
Question assessing how much anxiety felt during session, using Likert Scale (0-10), with 0 being no anxiety and 10 being extremely anxious.
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 24 May 2023.
- Derived from this study: PubMed 38291916Wilson JM, Franqueiro AR, Edwards RR, Chai PR, Schreiber KL. Individuals with fibromyalgia report greater pain sensitivity than healthy adults while listening to their favorite music: the contribution of negative affect. Pain Med. 2024 May 2;25(5):352-361. doi: 10.1093/pm/pnae005.
- Derived from this study: PubMed 36646399Colebaugh CA, Wilson JM, Flowers KM, Overstreet D, Wang D, Edwards RR, Chai PR, Schreiber KL. The Impact of Varied Music Applications on Pain Perception and Situational Pain Catastrophizing. J Pain. 2023 Jul;24(7):1181-1192. doi: 10.1016/j.jpain.2023.01.006. Epub 2023 Jan 14.
- Individual participant dataSharing planned: Undecided
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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.
Kristin L Schreiber, 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 music intervention in people with Pain, Acute and Pain, Chronic, 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 5 inclusion and 12 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 24 May 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. 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?
Modulation of Pressure Pain Threshold/Tolerance (time frame: 15 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087564, which also lists 2 linked publications.
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 24 May 2023.