Clinical trial NCT05578781: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: chronic
back pain
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-10-13
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial (RCT)
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Frontal Midline Theta Power
timeFrame: During the session
Secondary outcomes:
measure: Duration of benefits
timeFrame: Pre-Intervention, immediately after intervention, as well as 24 hours later
measure: Pain intensity
timeFrame: Pre-intervention and immediately after intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mark Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: