What side effects are associated with this type of intervention?

Common treatments for chronic pain that are similar to music therapy, such as relaxation techniques, guided imagery, and mindfulness-based stress reduction, generally have minimal side effects. These therapies are designed to reduce anxiety and pain perception through psychological and physiological mechanisms. Potential side effects may include temporary emotional discomfort as patients confront stressors or pain during therapy sessions. However, these interventions are generally considered safe and are associated with low risk of adverse effects compared to pharmacologic treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic pain that focus on both psychological and physiological effects. Notably, duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), has been approved for chronic musculoskeletal pain, including fibromyalgia. Additionally, gabapentin and pregabalin, which are gamma amino-butyric acid (GABA) agonists, are used off-label for chronic pain conditions like fibromyalgia. These treatments, while pharmacological, share a focus on modulating central nervous system activity, similar to the way music therapy aims to reduce anxiety and pain perception through psychological and physiological pathways.

What other types of research exist?

Promising novel alternatives to music therapy for chronic pain patients include: <ol> <li>Biofeedback-Assisted Relaxation: This technique has shown effectiveness in reducing pain and anxiety by helping patients control physiological functions.</li> <li>Mindfulness-Based Stress Reduction (MBSR): An evidence-based program that uses meditation practices to increase awareness and self-regulation, potentially improving pain and anxiety.</li> <li>Guided Imagery: This involves visualizing calming images to reduce pain and anxiety, and has shown benefits in cancer patients.</li> <li>Acupuncture/Acupressure: These traditional Chinese medicine techniques have been found to provide pain relief and reduce anxiety in some patients.</li> <li>Massage Therapy: This can improve mood and reduce pain, particularly in cancer patients, though the effects may not be long-lasting.</li> <li>Electroencephalogram (EEG)-Based Neurofeedback: This emerging technique shows potential in managing pain and anxiety by training patients to alter brain activity.</li> </ol>

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Music Therapy for Chronic Pain

N/A

Recruiting

Led By Bunty Shah

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 minutes following the subject's interventional procedure

Awards & highlights

Summary

This trial is testing if listening to music during treatment can help people with chronic lower back pain feel less anxious and in less pain. The study focuses on these patients because they often have high levels of anxiety and pain during treatments. The idea is that music can make them feel more relaxed and distracted from their pain.

Who is the study for?

This trial is for adults over 18 with chronic lower back pain who are undergoing standard lumbar procedures. It's not for those who can't consent, don't speak English, take beta blockers, have a pacemaker set at a fixed rate, or have hearing issues.

What is being tested?

The study tests if listening to music during lumbar procedures can reduce anxiety and pain. Patients will either receive music therapy or no music to see how it affects their reported feelings of anxiety and pain as well as changes in vital signs.

What are the potential side effects?

Since the intervention involves only playing music, there are no direct medical side effects expected from this treatment compared to typical clinical drug trials.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 minutes prior to the subject's interventional procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 minutes prior to the subject's interventional procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes prior to the subject's interventional procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Post-procedure State-Trait Anxiety Inventory (STAI) Score

Pre-procedure State-Trait Anxiety Inventory (STAI) Score

Secondary study objectives

Post procedural Visual Analog Score (VAS)

Pain

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Music TherapyExperimental Treatment1 Intervention

Music of the subject's preferred genre will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).

Group II: No MusicActive Control1 Intervention

No music will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).

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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 pain include pharmacologic options like NSAIDs and antidepressants, which work by reducing inflammation and altering neurotransmitter levels to modulate pain perception. Nonpharmacologic treatments, such as cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR), target the psychological aspects of pain by changing pain-related thoughts and behaviors, thereby reducing stress and improving coping mechanisms. Music therapy, similar to these psychological interventions, can reduce anxiety and alter pain perception through distraction, emotional engagement, and relaxation. These mechanisms are crucial for chronic pain patients as they address both the physical and emotional components of pain, leading to improved overall well-being and functional outcomes.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.

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Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

504 Previous Clinical Trials

2,795,910 Total Patients Enrolled

2 Trials studying Chronic Pain

119 Patients Enrolled for Chronic Pain

Bunty ShahPrincipal InvestigatorMilton S. Hershey Medical Center

Media Library

Music Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04924244 — N/A

Chronic Pain Research Study Groups: No Music, Music Therapy

Chronic Pain Clinical Trial 2023: Music Therapy Highlights & Side Effects. Trial Name: NCT04924244 — N/A

Music Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04924244 — N/A

~7 spots leftby Sep 2025

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