Using Music During Lumbar Medial Branch Block Procedure

Lower Back Pain Clinical Trial

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091607
• Other study ID #: IRB00060053
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: May 23, 2022

Study information

• Verified date: August 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.,).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain
• Lumbar Spondylosis
• Spondylosis

Intervention

Other:
• Music Therapy
Subject will listen to Music using provided ear buds or headphones.

Locations

Country	Name	City	State
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores with True Visual Analog scale	Score ranges from 0 to 10 with higher score denoting more pain.	Day 1 Pre Procedure
Primary	Pain Scores with True Visual Analog scale	Score ranges from 0 to 10 with higher score denoting more pain.	Day 1 Post Procedure