Using Music During Lumbar Medial Branch Block Procedure

Study Overview
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Brief Summary
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The purpose of this study is to determine if music therapy during interventional lumbar medial branch blocks for chronic lower back pain will lower pain scores and anxiety levels, while increasing patient desire for repeat procedure as well as patient satisfaction.

Detailed Description
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Subjects will be put into 1 of 2 groups, Music or the Control Group (no music). The music group will listen to patient's preferred music on Pandora station broadcast using Headphones or Wireless Earbuds with Tablet or Computer. Hearing impaired patients will have an option of non-earbud headphones. . Earbuds or headphones will be used regardless of music therapy playing. . The control group will be provided earbuds or alternative headphone as well, however, with no music. The sound environment will be standardized for procedure by closing procedure room door and minimizing extraneous sounds (i.e. from equipment, alarms, etc.,).

Official Title
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An Evaluation of Pain, Anxiety, Desire for Repeat Procedure, and Satisfaction Utilizing Music Therapy for Chronic Low Back Pain Patients During Lumbar Medial Branch Blocks

Conditions
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Lower Back Pain, Lumbar Spondylosis

Intervention / Treatment
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* Other: Music Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> or equal to 18 History of documented chronic lower back pain Exclusion Criteria: Patient refusal Deafness (unless corrected with a hearing aid) Initial Pain Score < 3 Prior Lumbar Medial Branch Blocks/Radiofrequency ablation therapy Any woman who is currently pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 will listen to Music during the procedure. Group 2 will not hear any music during the procedure
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music Therapy Intervention Group<br>listen to preferred choice of music during the Lumbar Medial Branch Block procedure. | Other: Music Therapy<br>* Subject will listen to Music using provided ear buds or headphones.<br>|
| No Intervention: Control Group<br>No music will be provided but will be provided earbuds. The sound environment will be standard for procedures by closing procedure room door and minimizing extraneous sounds. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores with True Visual Analog scale | Score ranges from 0 to 10 with higher score denoting more pain. | Day 1 Pre Procedure | 
| Pain Scores with True Visual Analog scale | Score ranges from 0 to 10 with higher score denoting more pain. | Day 1 Post Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar medial branch block, chronic back pain, lower back pain, lumbar spondylosis