Skip to main content
OpenTrials
Completed

NCT Number: NCT04644757

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Music listening

Other

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 outcomes

  1. Enrollment rate: Assessed as number enrolled or number who met inclusion criteria

    Time frame: 6 months from start of study

  2. Attrition rate

    Time frame: 6 months from start of study

    Assessed as number not completing the study divided by number enrolled at baseline

  3. Adherence rate

    Time frame: 6 months from start of study

    Assessed as number completing all measures divided by number enrolled

  4. 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).

  5. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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.).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Martel Scholarship

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.