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Completed

NCT Number: NCT04091607

Using Music During Lumbar Medial Branch Block Procedure

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.

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Key information

Conditions

Lower Back Pain Back Pain Bone Diseases Low Back Pain Lumbar Spondylosis Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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.,).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Other

Subject will listen to Music using provided ear buds or headphones.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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"

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2019
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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