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

Lower Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644757
• Other study ID #: HSC-SN-20-1092
• Status: Completed
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: July 13, 2021

Study information

• Verified date: July 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Martel Scholarship

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate: Assessed as number enrolled or number who met inclusion criteria		6 months from start of study
Primary	Attrition rate	Assessed as number not completing the study divided by number enrolled at baseline	6 months from start of study
Primary	Adherence rate	Assessed as number completing all measures divided by number enrolled	6 months from start of study
Primary	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).	Baseline
Primary	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).	5 days after baseline(1 day after completion of intervention)
Secondary	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.	Baseline
Secondary	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.	day 1
Secondary	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.	day 2
Secondary	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.	day 3
Secondary	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.	day 4
Secondary	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.	post intervention (day 5)
Secondary	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	Baseline
Secondary	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	Baseline
Secondary	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.	Baseline and post-intervention (Day 5)
Secondary	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	Baseline and post-intervention (Day 5)
Secondary	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.).	Baseline and post-intervention (Day 5)