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Using Music During Lumbar Medial Branch Block Procedure

Primary Purpose

Lower Back Pain, Lumbar Spondylosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lower Back Pain focused on measuring lumbar medial branch block, chronic back pain, lower back pain, lumbar spondylosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wake Forest University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Music Therapy Intervention Group

Control Group

Arm Description

listen to preferred choice of music during the Lumbar Medial Branch Block procedure.

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.

Outcomes

Primary Outcome Measures

Pain Scores with True Visual Analog scale
Score ranges from 0 to 10 with higher score denoting more pain.
Pain Scores with True Visual Analog scale
Score ranges from 0 to 10 with higher score denoting more pain.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
August 5, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04091607
Brief Title
Using Music During Lumbar Medial Branch Block Procedure
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"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.,).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain, Lumbar Spondylosis
Keywords
lumbar medial branch block, chronic back pain, lower back pain, lumbar spondylosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy Intervention Group
Arm Type
Active Comparator
Arm Description
listen to preferred choice of music during the Lumbar Medial Branch Block procedure.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
Subject will listen to Music using provided ear buds or headphones.
Primary Outcome Measure Information:
Title
Pain Scores with True Visual Analog scale
Description
Score ranges from 0 to 10 with higher score denoting more pain.
Time Frame
Day 1 Pre Procedure
Title
Pain Scores with True Visual Analog scale
Description
Score ranges from 0 to 10 with higher score denoting more pain.
Time Frame
Day 1 Post Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Columbano, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Music During Lumbar Medial Branch Block Procedure

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