Feasibility and Efficacy of Remotely Monitored Home-based Listening to Preferred Music for Pain in Older Adults With Low Back Pain

July 20, 2021 updated by: Setor K. Sorkpor, The University of Texas Health Science Center, Houston

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Other: Music Listening
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
Time Frame: 6 months from start of study
6 months from start of study
Attrition rate
Time Frame: 6 months from start of study
Assessed as number not completing the study divided by number enrolled at baseline
6 months from start of study
Adherence rate
Time Frame: 6 months from start of study
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
Time Frame: Baseline
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)
Time Frame: 5 days after baseline(1 day after completion of intervention)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain as measured by the numerical rating scale (NRS)
Time Frame: Baseline
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 7 days will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
Baseline
Pain as measured by the numerical rating scale (NRS)
Time Frame: day 1
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
day 1
Pain as measured by the numerical rating scale (NRS)
Time Frame: day 2
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
day 2
Pain as measured by the numerical rating scale (NRS)
Time Frame: day 3
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
day 3
Pain as measured by the numerical rating scale (NRS)
Time Frame: day 4
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
day 4
Pain as measured by the numerical rating scale (NRS)
Time Frame: post intervention (day 5)
Self-reported mean clinical pain intensity defined as the average pain intensity experienced in the past 24 hours will be measured using the 101-point NRS where 0 means no pain and 100 means worst imaginable pain.
post intervention (day 5)
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
Time Frame: Baseline
The PROMIS Anxiety Short Form has 8 items with each item on the measure being rated on a 5-point scale (1-5) , a higher number indicating a worse outcome
Baseline
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
Time Frame: Baseline
The PROMIS Depression Short Form has 8 items with each item on the measure being rated on a 5-point scale (1-5) , a higher number indicating a worse outcome
Baseline
Change in brain activation in the motor and somatosensory cortex as measured by functional near-infrared spectroscopy (fNIRS)
Time Frame: Baseline and post-intervention (Day 5)
Pain-related measure of hemodynamic response function will be measured during pressure pain stimulation using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm.
Baseline and post-intervention (Day 5)
Change in conditioned pain modulation (CPM)
Time Frame: Baseline and post-intervention (Day 5)
Conditioned pain modulation will measure the difference in pressure pain threshold before and after a painful "conditioning stimulus" is applied to test central pain inhibition. The conditioning stimulus will involve the immersion of one hand in a cold-water bath. The pressure pain tolerance will be evaluated following a conditioning stimulus condition
Baseline and post-intervention (Day 5)
Change in heart rate variability (HRV)
Time Frame: Baseline and post-intervention (Day 5)
Heart rate variability will be assessed as an indicates the sympathetic nervous system status using lead II arrangement with an MP160 Data Acquisition Systems (Biopac Systems, Inc., Goleta, CA, U.S.A.).
Baseline and post-intervention (Day 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Martel Scholarship

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Setor K Sorkpor, MPH,MSN,RN-BC, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-SN-20-1092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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