Back to resultsFeasibility and Efficacy of Remotely Monitored Home-based Listening to Preferred Music for Pain in Older Adults With Low Back Pain
Primary Purpose
Lower Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Listening
Sponsored by
About this trial
This is an interventional treatment trial for Lower Back Pain
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)
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
Attrition rate
Assessed as number not completing the study divided by number enrolled at baseline
Adherence rate
Assessed as number completing all measures divided by number enrolled
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).
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).
Secondary Outcome Measures
Pain as measured by the numerical rating scale (NRS)
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.
Pain as measured by the numerical rating scale (NRS)
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.
Pain as measured by the numerical rating scale (NRS)
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.
Pain as measured by the numerical rating scale (NRS)
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.
Pain as measured by the numerical rating scale (NRS)
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.
Pain as measured by the numerical rating scale (NRS)
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.
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
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
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
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
Change in brain activation in the motor and somatosensory cortex as measured by functional near-infrared spectroscopy (fNIRS)
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.
Change in conditioned pain modulation (CPM)
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
Change in heart rate variability (HRV)
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.).
Full Information
NCT ID
NCT04644757
First Posted
November 20, 2020
Last Updated
July 20, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Martel Scholarship
1. Study Identification
Unique Protocol Identification Number
NCT04644757
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
July 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Martel Scholarship
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Music Listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
Time Frame
6 months from start of study
Title
Attrition rate
Description
Assessed as number not completing the study divided by number enrolled at baseline
Time Frame
6 months from start of study
Title
Adherence rate
Description
Assessed as number completing all measures divided by number enrolled
Time Frame
6 months from start of study
Title
Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP
Description
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).
Time Frame
Baseline
Title
Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP)
Description
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).
Time Frame
5 days after baseline(1 day after completion of intervention)
Secondary Outcome Measure Information:
Title
Pain as measured by the numerical rating scale (NRS)
Description
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.
Time Frame
Baseline
Title
Pain as measured by the numerical rating scale (NRS)
Description
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.
Time Frame
day 1
Title
Pain as measured by the numerical rating scale (NRS)
Description
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.
Time Frame
day 2
Title
Pain as measured by the numerical rating scale (NRS)
Description
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.
Time Frame
day 3
Title
Pain as measured by the numerical rating scale (NRS)
Description
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.
Time Frame
day 4
Title
Pain as measured by the numerical rating scale (NRS)
Description
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.
Time Frame
post intervention (day 5)
Title
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
Description
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
Time Frame
Baseline
Title
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
Description
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
Time Frame
Baseline
Title
Change in brain activation in the motor and somatosensory cortex as measured by functional near-infrared spectroscopy (fNIRS)
Description
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.
Time Frame
Baseline and post-intervention (Day 5)
Title
Change in conditioned pain modulation (CPM)
Description
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
Time Frame
Baseline and post-intervention (Day 5)
Title
Change in heart rate variability (HRV)
Description
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.).
Time Frame
Baseline and post-intervention (Day 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Setor K Sorkpor, MPH,MSN,RN-BC
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility and Efficacy of Remotely Monitored Home-based Listening to Preferred Music for Pain in Older Adults With Low Back Pain
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