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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04091607
Other study ID # IRB00060053
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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