Back to resultsThe Impact of Music on Nociceptive Processing
Primary Purpose
Pain, Acute, Pain, Chronic, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
music intervention
Sponsored by
About this trial
This is an interventional basic science trial for Pain, Acute focused on measuring Music
Eligibility Criteria
Healthy volunteers no longer needed for this study (9/9/2021).
Inclusion criteria for Healthy volunteers (N=70) without a diagnosis of neuropathy or chronic pain:
- aged >18 years
- able to speak and understand English
- willingness to undergo psychophysical and psychosocial testing.
Exclusion criteria:
- diagnosed hearing loss
- diagnosis of chronic pain/neuropathy
- history of chronic opioid use (having an opioid prescription >30 days).
Inclusion criteria for Fibromyalgia patients: N=70:
- 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.
Exclusion criteria:
--diagnosed hearing loss.
HIV Patients with chronic pain: N=70
- aged >18- years
- 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.
Exclusion criteria:
--diagnosed hearing loss.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
music intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04087564
First Posted
November 13, 2017
Last Updated
May 23, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04087564
Brief Title
The Impact of Music on Nociceptive Processing
Official Title
Investigating Differences in Modulation of Nociceptive Processing by Music in Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Chronic, Anxiety, Anxiety Disorders, Catastrophization, Healthy
Keywords
Music
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each subject serves as their own control
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
music intervention
Other Intervention Name(s)
Unwind, Favorite Music, White Noise
Intervention Description
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
Primary Outcome Measure Information:
Title
Modulation of Pressure Pain Threshold/Tolerance
Description
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.
Time Frame
15 minutes
Title
Modulation of Temporal Summation with Repeated Pinpricks
Description
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.
Time Frame
15 minutes
Title
Modulation of Temporal Summation with Pressure Cuff
Description
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.
Time Frame
15 minutes
Title
Modulation of Heat Pain Threshold and Tolerance
Description
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.
Time Frame
15 minutes
Title
Modulation of Heat Offset Analgesia
Description
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).
Time Frame
15 minutes
Title
Modulation of Conditioned Pain Modulation
Description
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.
Time Frame
15 minutes
Title
Modulation of Anxiety
Description
Question assessing how much anxiety felt during session, using Likert Scale (0-10), with 0 being no anxiety and 10 being extremely anxious.
Time Frame
10 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy volunteers no longer needed for this study (9/9/2021).
Inclusion criteria for Healthy volunteers (N=70) without a diagnosis of neuropathy or chronic pain:
aged >18 years
able to speak and understand English
willingness to undergo psychophysical and psychosocial testing.
Exclusion criteria:
diagnosed hearing loss
diagnosis of chronic pain/neuropathy
history of chronic opioid use (having an opioid prescription >30 days).
Inclusion criteria for Fibromyalgia patients: N=70:
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.
Exclusion criteria:
--diagnosed hearing loss.
HIV Patients with chronic pain: N=70
aged >18- years
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.
Exclusion criteria:
--diagnosed hearing loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin L Schreiber, MD PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02155
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Impact of Music on Nociceptive Processing
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