NCT04644757

Brief Summary

The purpose of this study is to examine the feasibility and acceptability of listening to 20 minutes of preferred style of music twice-daily for 4 consecutive days on pain among 20 community-dwelling older adults with lower back pain (LBP)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

November 20, 2020

Last Update Submit

July 20, 2021

Conditions

Lower Back Pain

Outcome Measures

Primary Outcomes (5)

  • Enrollment rate: Assessed as number enrolled or number who met inclusion criteria

    6 months from start of study

  • Attrition rate

    Assessed as number not completing the study divided by number enrolled at baseline

    6 months from start of study

  • Adherence rate

    Assessed as number completing all measures divided by number enrolled

    6 months from start of study

  • Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP

    Assess perceived acceptability of treatment using TAP in four categories of appropriateness, effectiveness, suitability, and willingness to adhere on a scale ranging from 0 (not at all) to 4 (very much).

    Baseline

  • Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP)

    Assess perceived acceptability of treatment using TAP in four categories of appropriateness, effectiveness, suitability, and willingness to adhere on a scale ranging from 0 (not at all) to 4 (very much).

    5 days after baseline(1 day after completion of intervention)

Secondary Outcomes (11)

  • Pain as measured by the numerical rating scale (NRS)

    Baseline

  • Pain as measured by the numerical rating scale (NRS)

    day 1

  • Pain as measured by the numerical rating scale (NRS)

    day 2

  • Pain as measured by the numerical rating scale (NRS)

    day 3

  • Pain as measured by the numerical rating scale (NRS)

    day 4

  • +6 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL
Other: Music Listening

Interventions

Music ListeningOTHER

The study will employ an individual receptive relaxation music method with participants selecting music based on their preference from a selection of various styles from the MUSIC CARE© app. The music intervention will last 20 minutes per session and will be administered twice daily for 4 consecutive days. Participants will be given an electronic tablet with the MUSIC CARE© app loaded on it and trained on how to access the app to select their preferred style of music.Participants will be instructed to use the provided headphone during all interventions and to sit in a quiet area while wearing an ocular mask to avoid distractions.The PI will remotely monitor each of the music intervention sessions in real-time monitoring via a secured video conferencing interface to ensure adherence to study protocol.

Treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • self-report of Lower back pain (LBP)
  • LBP in the past 3 months with an average rating of at least 30 on a 0 - 100 NRS for pain
  • intact cognition
  • no plans to change their pain medication regimens during the study time
  • can read and understand English
  • can travel to the study center
  • agree to sign an informed consent

You may not qualify if:

  • deaf or have severe hearing loss
  • pregnant or lactating
  • have an implantable pain-reducing device
  • history of hospitalization within the preceding year for psychiatric illness
  • diagnosis of Raynaud's disease
  • have a functional limitation that requires the use of an ambulatory aid such as a cane, walker, or wheelchair
  • history of brain surgery, brain tumor, or stroke
  • severe depression (PROMIS Depression T-score ≥ 70) (Kroenke et al., 2020)
  • severe anxiety (PROMIS Anxiety ≥ 70) (American Psychiatric Association, 2013)
  • Mini-Mental State Examination score less than 24 (Creavin, Wisniewski, Noel-Storr, et al., 2016)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Setor K Sorkpor, MPH,MSN,RN-BC

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 25, 2020

Study Start

May 13, 2021

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)