Lower Back PainNCT04644757
Feasibility and Efficacy of Remotely Monitored Home-based Listening to Preferred Music for Pain in Older Adults With Low Back Pain
A study testing Music Listening in people with Lower Back Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Music Listening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2021to 13 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
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)
- Conditions
- Lower Back Pain
- Being tested
- Music Listening
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
Measured: 6 months from start of study
Attrition rate
Assessed as number not completing the study divided by number enrolled at baseline
Measured: 6 months from start of study
Adherence rate
Assessed as number completing all measures divided by number enrolled
Measured: 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).
Measured: 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).
Measured: 5 days after baseline(1 day after completion of intervention)
Secondary outcomes (11)
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.
Measured: Baseline
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.
Measured: day 1
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.
Measured: day 2
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.
Measured: day 3
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.
Measured: day 4
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.
Measured: post intervention (day 5)
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
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline and post-intervention (Day 5)
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
Measured: Baseline and post-intervention (Day 5)
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.).
Measured: Baseline and post-intervention (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start13 May 2021
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Martel Scholarship
- Responsible party
- Principal investigator, Setor K. Sorkpor, The University of Texas Health Science Center, Houston
- Investigators
- Setor K Sorkpor, MPH,MSN,RN-BC, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644757
- Sponsor's protocol ID
- HSC-SN-20-1092
- Status last verified
- Jul 2021
- First submitted
- 20 Nov 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04644757
- Acronym / sponsor ID
- HSC-SN-20-1092
- Conditions
- Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Martel Scholarship
- Study start
- 13 May 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Music Listening |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ListeningThe 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. | Other | Treatment |
Primary outcome
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
Time frame: 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
Adherence rate
Time frame: 6 months from start of study
Assessed as number completing all measures divided by number enrolled
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).
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).
11 secondary outcomes
Pain as measured by the numerical rating scale (NRS)
Time frame: Baseline
Pain as measured by the numerical rating scale (NRS)
Time frame: day 1
Pain as measured by the numerical rating scale (NRS)
Time frame: day 2
Pain as measured by the numerical rating scale (NRS)
Time frame: day 3
Pain as measured by the numerical rating scale (NRS)
Time frame: day 4
Pain as measured by the numerical rating scale (NRS)
Time frame: post intervention (day 5)
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form
Time frame: Baseline
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
Time frame: 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)
Change in conditioned pain modulation (CPM)
Time frame: Baseline and post-intervention (Day 5)
Change in heart rate variability (HRV)
Time frame: Baseline and post-intervention (Day 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Setor K Sorkpor, MPH,MSN,RN-BC principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening in people with Lower Back Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria (time frame: 6 months from start of study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.