Music-based Treatments and Pain: Underlying Mechanisms and the Beneficial Effects of Music-Based Treatments
2 other identifiers
interventional
99
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedStudy Start
First participant enrolled
January 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2024
CompletedAugust 7, 2025
August 1, 2025
1.8 years
October 6, 2022
August 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frontal Midline Theta Power
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.
During the session
Secondary Outcomes (2)
Duration of benefits
Pre-Intervention, immediately after intervention, as well as 24 hours later
Pain intensity
Pre-intervention and immediately after intervention
Study Arms (4)
Music Therapy
EXPERIMENTALThe Music Therapy (MT) group will participate in 1 live session of music therapy with a board certified Music therapist while wearing an EEG cap. Afterwards, they will complete a brief questionnaire about the experience and pain. They will also complete a brief questionnaire 24 hours later about lasting effects and pain
Music Medicine
EXPERIMENTALThe Music Medicine (MM) group will participate in 1 audio session of music while wearing an EEG cap. Afterwards, they will complete a brief questionnaire about the experience and pain. They will also complete a brief questionnaire 24 hours later about lasting effects and pain
Control condition
EXPERIMENTALthe Control group will participate in 1 session of an audio of text being read to them while wearing an EEG cap. Afterwards, they will complete a brief questionnaire about the experience and pain. They will also complete a brief questionnaire 24 hours later about lasting effects and pain
Control group without low back pain
ACTIVE COMPARATORThis group will participate in 1 session of an audio of the music therapy session while wearing an EEG cap. Afterwards, they will complete a brief questionnaire about the experience and pain. They will also complete a brief questionnaire 24 hours later about the lasting effects and pain
Interventions
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
Eligibility Criteria
You may qualify if:
- ≥18 years old
- Meets criteria for Chronic Low Back Pain (CLBP)
- Moderate to severe pain intensity on average (i.e., average pain in the past week ≥4 on the 0-10 NRS)
- Able to read, speak, and understand English
- ≥18 years old
- Able to read, speak, and understand English
You may not qualify if:
- Cognitive impairment that could interfere with study participation defined as ≥1 error on the 6-Item
- Presence of a psychiatric condition (e.g. significant suicidal ideation, active psychotic symptoms that would interfere with study participation
- Having a significant hearing disability that interferes with the potential participant's ability to hear music
- Having a health condition associated,per both chart review and self-report, with central nervous system damage (e.g., epilepsy, traumatic head injury, multiple sclerosis, Parkinson's).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Jensen, Ph.D.
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, School of Medicine: Rehabilitation Medicine
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 13, 2022
Study Start
January 26, 2023
Primary Completion
November 14, 2024
Study Completion
November 14, 2024
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- In order to obtain data, investigators who request it will be asked to indicate the specific analyses planned for those data, agree to not conduct any additional analyses not specified, agree not to share the data with others, and to destroy the data within a year of receipt or after the findings are published, whichever comes first.
- Access Criteria
- The PI of the project (Mark Jensen) will review all data requests.
De-identified data that were used for the analyses presented in any paper published will be made available starting when the paper has been published to researchers who request it as long as they sign a data sharing agreement.