Clinical trial NCT04644757: Feasibility and Efficacy of Remotely Monitored Home-based Listening to Preferred Music for Pain in Older Adults With Low Back Pain
Official title: Feasibility and Efficacy of Remotely Monitored Home-based Listening to Preferred Music for Pain in Older Adults With Low Back Pain: A Pilot Study of Feasibility and Acceptability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Martel Scholarship
First posted: 2020-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
timeFrame: 6 months from start of study
measure: Attrition rate
timeFrame: 6 months from start of study
measure: Adherence rate
timeFrame: 6 months from start of study
measure: Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP
timeFrame: Baseline
measure: Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP)
timeFrame: 5 days after baseline(1 day after completion of intervention)
Secondary outcomes:
measure: Pain as measured by the numerical rating scale (NRS)
timeFrame: Baseline
measure: Pain as measured by the numerical rating scale (NRS)
timeFrame: day 1
measure: Pain as measured by the numerical rating scale (NRS)
timeFrame: day 2
measure: Pain as measured by the numerical rating scale (NRS)
timeFrame: day 3
measure: Pain as measured by the numerical rating scale (NRS)
timeFrame: day 4
measure: Pain as measured by the numerical rating scale (NRS)
timeFrame: post intervention (day 5)
measure: Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
timeFrame: Baseline
measure: Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
timeFrame: Baseline
measure: Change in brain activation in the motor and somatosensory cortex as measured by functional near-infrared spectroscopy (fNIRS)
timeFrame: Baseline and post-intervention (Day 5)
measure: Change in conditioned pain modulation (CPM)
timeFrame: Baseline and post-intervention (Day 5)
measure: Change in heart rate variability (HRV)
timeFrame: Baseline and post-intervention (Day 5)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Setor K Sorkpor, MPH,MSN,RN-BC
role: PRINCIPAL_INVESTIGATOR
References: