Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04059042
Status:
TERMINATED
Last Update Posted:
2023-12-15
First Post:
2019-08-13
Brief Title:
Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Analgesic Effect of Music Listening During Pain Elicitation in Fibromyalgia
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Research activities suspended March 2020 due to COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMMusic
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None