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The Impact of Music on Nociceptive Processing

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ClinicalTrials.gov Identifier: NCT04087564
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Kristin Schreiber, Brigham and Women's Hospital

Brief Summary:
The investigators are studying the ways that different music may change pain perception

Condition or disease Intervention/treatment Phase
Pain, Acute Pain, Chronic Anxiety Anxiety Disorders Catastrophization Healthy Other: music intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Each subject serves as their own control
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating Differences in Modulation of Nociceptive Processing by Music in Chronic Pain Patients
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • Other: music intervention

    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

    Other Names:
    • Unwind
    • Favorite Music
    • White Noise


Primary Outcome Measures :
  1. 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.120 This process will be repeated on the trapezius and the forearm, alternating between sides of the body with 20 seconds between measurements.

  2. 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.

  3. 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 4/10. 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.

  4. 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.

  5. 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).

  6. Modulation of Conditioned Pain Modulation [ Time Frame: 15 minutes ]
    CPM will be measured by adaptations of testing procedures used in our previous studies.123 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 dominant hand). The participant will be asked to submerge their right hand (up to above the wrist) into a cold-water bath set at 5°C. Approximately 5 seconds after placing hand in cold water bath, a constant, increasing pressure (1 lb/s) will again be applied to the contralateral trapezius with participant indicating when they start to feel pain (threshold) and when they want the pressure to stop (tolerance). CPM will be defined as: CPM=((pressure pain in presence- pressure pain in absence of cold pain)/pressure pain in absence of cold pain) *100). Participants will be asked

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087564


Contacts
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Contact: Emily Schwartz, BS 4017148720 eschwartz6@bwh.harvard.edu
Contact: Kristin Schreiber, MDPhD klschreiber@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02155
Contact: Kristin L Schreiber, MD PhD    612-205-0186    klschreiber@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Kristin L Schreiber, MD PhD Brigham and Women's Hospital

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Responsible Party: Kristin Schreiber, Assistant Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04087564     History of Changes
Other Study ID Numbers: 2019P000824
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristin Schreiber, Brigham and Women's Hospital:
Music
Additional relevant MeSH terms:
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Acute Pain
Chronic Pain
Anxiety Disorders
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms