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Using Music During Lumbar Medial Branch Block Procedure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04091607
Enrollment
150
Registered
2019-09-17
Start date
2019-11-15
Completion date
2022-05-23
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Back Pain, Lumbar Spondylosis

Keywords

lumbar medial branch block, chronic back pain, lower back pain, lumbar spondylosis

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.,).

Interventions

OTHERMusic Therapy

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Group 1 will listen to Music during the procedure. Group 2 will not hear any music during the procedure

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Scores with True Visual Analog scaleDay 1 Pre ProcedureScore ranges from 0 to 10 with higher score denoting more pain.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026