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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Therapy Intervention Group | Active Comparator | listen to preferred choice of music during the Lumbar Medial Branch Block procedure. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy | Other | Subject will listen to Music using provided ear buds or headphones. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Columbano, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 25, 2022 | Aug 5, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Group 1 will listen to Music during the procedure. Group 2 will not hear any music during the procedure
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |