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Using Music During Lumbar Medial Branch Block Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091607
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lower Back Pain Lumbar Spondylosis Other: Music Therapy Not Applicable

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.,).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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"
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Back Pain

Arm Intervention/treatment
Active Comparator: Music Therapy Intervention Group
listen to preferred choice of music during the Lumbar Medial Branch Block procedure.
Other: Music Therapy
Subject will listen to Music using provided ear buds or headphones.

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Pain Scores with True Visual Analog scale [ Time Frame: Day 1 Pre Procedure ]
    Score ranges from 0 to 10 with higher score denoting more pain.

  2. Pain Scores with True Visual Analog scale [ Time Frame: Day 1 Post Procedure ]
    Score ranges from 0 to 10 with higher score denoting more pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091607


Contacts
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Contact: Carolyn Hendrick 336.716.2993 cwhedric@wakehealth.edu
Contact: Heather Columbano, MD hcolumba@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University School of Medicine Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Heather Columbano, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04091607     History of Changes
Other Study ID Numbers: IRB00060053
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
lumbar medial branch block
chronic back pain
lower back pain
lumbar spondylosis
Additional relevant MeSH terms:
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Spondylosis
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases