University of Washington
Seattle, Washington, 98195, United States
NCT Number: NCT05578781
The purpose of this study is to understand the mechanisms that underlie the beneficial effects of music-based treatments in individuals with moderate to severe chronic low back pain
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98195, United States
A growing body of research indicates that music may be used effectively for improving a variety of symptoms, including pain. However, little is known about the mechanisms that underlie the beneficial effects of music-based treatments. The primary objective of this R21 exploratory study is to evaluate the feasibility of performing a full R01 study in a sample of individuals with moderate to severe chronic low back pain to address knowledge gaps regarding the mechanisms of music-based treatments. To address the primary aims of this study, the investigators will conduct a 3-arm pilot trial in which individuals with chronic low back pain will be randomly assigned to one of three conditions: (1) live music played by a board-certified music therapist (Music Therapy), (2) audio recorded music (Music Medicine), or (3) audio of a person reading written text (n = 20 subjects per condition). In addition, 20 individuals without chronic pain will be enrolled and assigned to the Music Medicine condition.
An EEG assessment measuring brain oscillation spectral power will be conducted before and during a session of each experimental condition. Measures of pain intensity will be administered before and after the sessions. Low back pain was selected because it is among the most common, costly, and disabling chronic pain problems; including a non-pain sample will also allow us to determine if having chronic pain or not influences the effects of music on the primary mechanism variables. Effect sizes will be computed to evaluate (1) the effects of the treatments on frontal midline theta power and (2) the mediation effects of changes in frontal midline theta power on the pre- to post-session effects of the music conditions, relative to the control condition. The investigators will also investigate the differences between the three music conditions, compare the effects of Music Medicine on the mechanism variables as a function of having or not having chronic pain, and explore the extent to which the experimental conditions have lingering effects on pain intensity and secondary outcomes (depression, pain interference, and sleep quality) during the 24 hours after the experimental sessions. The investigators will also perform interviews and qualitative data analyses to identify additional unanticipated effects of the experimental conditions that would be worth examining more closely in a full R01 study. The findings from this study will be used to determine if a full R01 study to evaluate the mechanisms of music-based treatments is warranted, and to inform the design of such as study. This program of research will provide important foundational knowledge regarding the mechanisms of music-based interventions. Transferred to clinical care, this knowledge could help in patient-treatment matching which would enhance the overall effectiveness for music-based treatments and other non-pharmacological treatments that may operate via their effects on brain states, as measured by EEG.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Chronic Low Back Pain sample:
Inclusion criterion for the non-pain sample:
Exclusion criteria
Music Therapy is a music session with a live therapist and has been shown to reduce pain and anxiety. If effective the music medicine in this RCT will be used help design a full R01 study
Music Medicine is an audio recorded music therapy session that will be played for the participant. This will be the same music session that will be played live in the music therapy session.
Control group will listen to an audio recording of text being spoken by the board certified music therapist
Time frame: During the session
Frontal midline theta power will be assessed using EEG assessment measuring brain oscillation spectral power for 5-min before and during each 20-min session.
Time frame: Pre-Intervention, immediately after intervention, as well as 24 hours later
Estimated time of pain relief during the24 hours after the session, estimated using a 0-10 Numerical Rating scale.
Time frame: Pre-intervention and immediately after intervention
Will be assessed using 0-10 Numerical Rating Scales (NRS).
University of Washington
Other
Music-based Treatments and Pain: Underlying Mechanisms
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