Using Music During Lumbar Medial Branch Block Procedure

NCT ID: NCT04091607

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2022-05-23

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.,).

Conditions

Lower Back Pain; Lumbar Spondylosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Music Therapy Intervention Group

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

Group Type: ACTIVE_COMPARATOR

Music Therapy

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Therapy

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Columbano, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00060053

Identifier Type: -

Identifier Source: org_study_id