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临床试验/NCT05578781
NCT05578781已完成不适用

Music-based Treatments and Pain: Underlying Mechanisms

University of Washington2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2023年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
2
主要终点
Frontal Midline Theta Power

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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).

结局指标

主要结局

Frontal Midline Theta Power

时间窗: 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.

次要结局

  • Duration of benefits(Pre-Intervention, immediately after intervention, as well as 24 hours later)
  • Pain intensity(Pre-intervention and immediately after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Jensen

Professor, School of Medicine: Rehabilitation Medicine

University of Washington

研究点 (2)

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