- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644757
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
Study Type
Interventional
Enrollment (Actual)
20
Phase
- 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
-
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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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
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 |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
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.
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What is the study measuring?
Primary Outcome Measures
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
|
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Attrition rate
Time Frame: 6 months from start of study
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Assessed as number not completing the study divided by number enrolled at baseline
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6 months from start of study
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Adherence rate
Time Frame: 6 months from start of study
|
Assessed as number completing all measures divided by number enrolled
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6 months from start of study
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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).
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Baseline
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Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP)
Time Frame: 5 days after baseline(1 day after completion of intervention)
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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).
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5 days after baseline(1 day after completion of intervention)
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Secondary Outcome Measures
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
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Pain as measured by the numerical rating scale (NRS)
Time Frame: day 1
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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.
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day 1
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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.
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day 2
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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.
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day 3
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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
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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.
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post intervention (day 5)
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Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
Time Frame: Baseline
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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)
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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.
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Baseline and post-intervention (Day 5)
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Change in conditioned pain modulation (CPM)
Time Frame: Baseline and post-intervention (Day 5)
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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
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Baseline and post-intervention (Day 5)
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Change in heart rate variability (HRV)
Time Frame: Baseline and post-intervention (Day 5)
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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.).
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Baseline and post-intervention (Day 5)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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)
May 13, 2021
Primary Completion (Actual)
July 13, 2021
Study Completion (Actual)
July 13, 2021
Study Registration Dates
First Submitted
November 20, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 25, 2020
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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