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Music-based Treatments and Pain: Underlying Mechanisms and the Beneficial Effects of Music-Based Treatments

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Music Medicine
Control group
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring chronic, back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Chronic Low Back Pain sample:

  • ≥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

Inclusion criterion for the non-pain sample:

  • ≥18 years old
  • Able to read, speak, and understand English

Exclusion Criteria:

  • 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).

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Music Therapy

Music Medicine

Control condition

Control group without low back pain

Arm Description

The 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

The 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

the 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

This 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of benefits
Estimated time of pain relief during the24 hours after the session, estimated using a 0-10 Numerical Rating scale.
Pain intensity
Will be assessed using 0-10 Numerical Rating Scales (NRS).

Full Information

First Posted
October 6, 2022
Last Updated
June 28, 2023
Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05578781
Brief Title
Music-based Treatments and Pain: Underlying Mechanisms and the Beneficial Effects of Music-Based Treatments
Official Title
Music-based Treatments and Pain: Underlying Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
chronic, back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial (RCT)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
The 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
Arm Title
Music Medicine
Arm Type
Experimental
Arm Description
The 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
Arm Title
Control condition
Arm Type
Experimental
Arm Description
the 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
Arm Title
Control group without low back pain
Arm Type
Active Comparator
Arm Description
This 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
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Music Medicine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Control group will listen to an audio recording of text being spoken by the board certified music therapist
Primary Outcome Measure Information:
Title
Frontal Midline Theta Power
Description
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
During the session
Secondary Outcome Measure Information:
Title
Duration of benefits
Description
Estimated time of pain relief during the24 hours after the session, estimated using a 0-10 Numerical Rating scale.
Time Frame
Pre-Intervention, immediately after intervention, as well as 24 hours later
Title
Pain intensity
Description
Will be assessed using 0-10 Numerical Rating Scales (NRS).
Time Frame
Pre-intervention and immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Chronic Low Back Pain sample: ≥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 Inclusion criterion for the non-pain sample: ≥18 years old Able to read, speak, and understand English Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Wasmund
Phone
206-897-6322
Email
ericaw8@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Gertz
Phone
206-616-8630
Email
kjgertz@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Jensen, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Jensen
Phone
206-543-3185
Email
mjensen@uw.edu
First Name & Middle Initial & Last Name & Degree
Erica A Wasmund
Phone
206-897-6322
Email
ericaw8@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
The PI of the project (Mark Jensen) will review all data requests.

Learn more about this trial

Music-based Treatments and Pain: Underlying Mechanisms and the Beneficial Effects of Music-Based Treatments

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