What side effects are associated with this type of intervention?

Common treatments for chronic lower back pain that are similar to music-based treatments include music therapy, acupuncture, and other mind-body practices like meditation and relaxation therapy. Music therapy is generally safe with minimal side effects, though some individuals may experience temporary emotional discomfort as they process feelings. Acupuncture is also considered safe when performed by trained practitioners, with rare side effects such as minor bleeding, bruising, or soreness at needle sites. Mind-body practices like meditation and relaxation therapy are typically low-risk, but some individuals may experience initial discomfort or increased anxiety as they learn to focus inwardly.

What prior FDA approvals exist?

The FDA has approved various pharmacologic treatments for chronic lower back pain, including NSAIDs, acetaminophen, and certain antidepressants with analgesic properties. Non-pharmacologic therapies such as cognitive behavioral therapy, physical therapy, and mindfulness-based stress reduction have also been recommended. While music-based treatments specifically for chronic lower back pain have not been explicitly approved by the FDA, the therapeutic use of music to modulate pain perception and emotional response is supported by research and is considered a beneficial complementary therapy.

What other types of research exist?

Promising novel alternatives to music-based treatments for chronic lower back pain in 2024 include: 1) Transcutaneous supraorbital nerve stimulation, which has shown significant pain reduction in clinical trials. 2) Remote electrical neuromodulation, which uses nonpainful electrical skin stimulation to reduce pain. 3) Biofeedback, which can increase pain threshold and reduce pain facilitation. 4) Integrative therapies such as meditation, mindfulness-based interventions, and massage therapy, which have shown potential benefits in pain management with minimal risks.

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Music Therapy for Chronic Lower Back Pain

N/A

Recruiting

Led By Mark Jensen, Ph.D.

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe pain intensity on average (i.e., average pain in the past week ≥4 on the 0-10 NRS)

Meets criteria for Chronic Low Back Pain (CLBP)

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention and immediately after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if different types of music therapy can help people with chronic low back pain by changing their brain activity and reducing pain. The study will use live music, recorded music, and listening to text, and measure brain waves to understand how these treatments work.

Who is the study for?

This trial is for adults over 18 who can read and understand English, experiencing moderate to severe chronic low back pain. They must not have significant hearing disabilities, central nervous system damage like epilepsy or traumatic head injury, cognitive impairments that affect study participation, or interfering psychiatric conditions.

What is being tested?

The study aims to explore how music-based treatments can help with chronic lower back pain. Participants will be divided into three groups: one receiving no musical intervention (control), another getting 'Music Medicine', and the third undergoing 'Music Therapy'.

What are the potential side effects?

Since this trial involves non-invasive music-based interventions, there are typically no direct physical side effects expected. However, individual emotional responses to music may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average pain level in the past week was 4 or higher on a scale of 0-10.

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I have been diagnosed with chronic low back pain.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition like epilepsy or MS that affects my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the session

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frontal Midline Theta Power

Secondary study objectives

Duration of benefits

Pain intensity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Music TherapyExperimental Treatment1 Intervention

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

Group II: Music MedicineExperimental Treatment1 Intervention

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

Group III: Control conditionExperimental Treatment1 Intervention

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

Group IV: Control group without low back painActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control group

2020

N/A

~1870

Music Therapy

2019

Completed Phase 3

~1660

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic lower back pain, such as cognitive-behavioral therapy (CBT), exercise, and mind-body practices like mindfulness and relaxation techniques, work by modulating pain perception and emotional response. CBT helps patients reframe negative thoughts about pain, reducing its perceived intensity. Exercise improves physical function and releases endorphins, which are natural painkillers. Mind-body practices promote relaxation and reduce stress, which can exacerbate pain. These mechanisms are crucial for chronic lower back pain patients as they address both the physical and psychological aspects of pain, leading to more comprehensive and effective pain management.

Visually induced analgesia during massage treatment in chronic back pain patients.Music Intervention Reduces Persistent Fibromyalgia Pain and Alters Functional Connectivity Between the Insula and Default Mode Network.[Active music therapy for chronic pain: a prospective study].