Using Music During Lumbar Medial Branch Block Procedure

NCT04091607 | Completed

• 1 other identifier: IRB00060053
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Back Pain; Lumbar Spondylosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pain Scores with True Visual Analog scale

  Score ranges from 0 to 10 with higher score denoting more pain.

  Day 1 Pre Procedure

• Pain Scores with True Visual Analog scale

  Score ranges from 0 to 10 with higher score denoting more pain.

  Day 1 Post Procedure

Study Arms (2)

Music Therapy Intervention Group

ACTIVE COMPARATOR

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

Other: Music Therapy

Control Group

NO INTERVENTION

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.

Interventions

Music Therapy OTHER

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

Music Therapy Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> or equal to 18
• History of documented chronic lower back pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Low Back Pain; Spondylosis

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Heather Columbano, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: November 15, 2019
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)