Using Music During Lumbar Medial Branch Block Procedure

Not Applicable

Completed

• Conditions: Lower Back Pain; Lumbar Spondylosis

• Registration Number: NCT04091607
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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.,).

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2019-11-15
• Primary Completion: 2022-05-23
• Study Completion: 2022-05-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Scores with True Visual Analog scale	Day 1 Post Procedure	Score ranges from 0 to 10 with higher score denoting more pain.

Trial Locations

Locations (1)

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States