Low Back PainNCT04785963
Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults
A study testing Music with Suggestion, Pain Information and Music in people with Low Back Pain and Chronic Pain, run by Baylor University at 1 site in United States.
Trial summary
The long-range goal is to reduce suffering and establish alternative options for older adults experiencing pain. This is a randomized controlled study examining the effect of music on pain management in older adults. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Low Back Pain, Chronic Pain, Sleep
- What is being tested?
- Music with Suggestion, Pain Information and Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 4 May 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be at least 50 years of age
- Participant must regularly experience moderate to severe chronic, lower back pain as determined by a self-reported pain rating of ≥ 5 on 11-point numerical rating scale
- Duration of pain must be ≥ 6 months
- Participant must be proficient and able to speak, read, and write in English
- Participant must have access to a computer or mobile device, Internet, and be willing to participate in virtual sessions and use electronic platforms to complete materials
Who cannot join
- Presence of any psychiatric condition or symptom that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking
- History of mental illness (i.e., psychosis, schizophrenia)
- Non-English speaker
- Pain classified as neuropathic as detected by the Pain Detect Questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults: A Randomized Controlled Study
The long-range goal is to reduce suffering and establish alternative options for older adults experiencing pain. This is a randomized controlled study examining the effect of music on pain management in older adults.
Read the detailed description
Study Objectives:
- Evaluate the efficacy of the music with suggestion intervention for chronic lower back pain in aging adults, with the indication that music with suggestion will significantly decrease subjective measures of pain compared to controls of music without suggestion or an informational recording about chronic pain.
- Evaluate the efficacy of the music with suggestion intervention for sleep in aging adults, with the indication that music with suggestion will significantly improve subjective measures of sleep compared to controls of music without suggestion or an informational recording about chronic pain.
- Evaluate the efficacy of the music with suggestion intervention for mood in aging adults, with the indication that music with suggestion will significantly improve subjective measures of mood compared to controls of music without suggestion or an informational recording about chronic pain.
Recruitment Plan
There will be 66 participants who wish to utilize mind-body interventions as treatment for chronic lower back pain.
The individual's eligibility will be determined using an Inclusion/Exclusion Criteria Screening Checklist containing the criteria listed above. If an individual appears to be eligible, he/she will be educated about the study purpose, procedures, and requirements. If the individual is interested in participating, they will sign a consent form, which may be signed through mail, through electronic platforms such as DocuSign, or in-person. The participant will be scheduled for their first formal education session and informed consent will take place during this session. This education session will take place through a video conference platform. All three groups will meet with a research staff member approximately five times (once during the education session and approximately once per week each following week) throughout the duration of the study. These sessions will take place through a video conference platform.
- Conditions
- Low Back Pain, Chronic Pain, Sleep, Aging
- Being tested
- Music with Suggestion, Pain Information, Music
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music with SuggestionBehavioural
A nonpharmacological, short-term treatment that poses minimal risk and places very limited burden on patients seems ideal for this population, and music with suggestions is one such treatment option.
Pain InformationBehavioural
The comparison condition of informational recordings about chronic pain are structured to account for non-specific effects of general time and attention and to evaluate whether the treatments of music alone, and music in combination with suggestion are effective in the reduction of pain intensity more than an appropriate control group.
MusicBehavioural
The comparison condition of the music only is structured to account for the effect of music listening, and to evaluate whether the addition of suggestion optimizes its effectiveness in the reduction of pain intensity.
| Study group | Role | What they receive |
|---|---|---|
| Music with Suggestion | Experimental | Active condition where participants will be provided with recordings of pre-determined music in addition to recorded suggestions instructing the participant on how to listen to the music. Receives: Behavioral: Music with Suggestion |
| Music | Active comparator | Control group where participants will be provided recordings of pre-determined music Receives: Behavioral: Pain Information |
| Pain Information | Active comparator | Non-arts group receiving structured attention and standard care Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Scale
Subjective measures of pain intensity, which will be determined using a Pain Intensity Scale. This measure will be completed daily where participants will be asked to rate the intensity of their pain on a scale from 0 (No Pain) to 10 (Very Intense Pain). Higher scores will indicate greater pain intensity.
Measured: Daily
Secondary outcomes (6)
Pain Suffering Visual Analogue Scale (VAS)
To measure pain suffering. Participants will be asked to rate their level of suffering from pain on a 0 (No Suffering) to 10 (Extreme Suffering) scale. Higher scores will indicate greater pain suffering.
Measured: Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
To measure sleep disturbance. This scale measures self-report 1) sleep quality, 2) sleep depth, and 3) restoration associated with sleep. This scale includes 8 items measured on a 5-point scale.
Measured: Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form
To measure depression. This measure assesses self-reported experiences of negative mood, decreased positive affect and decreased engagement over the past 7 days on a 1 (never) to 5 (always) scale. This scale includes 8 items with higher scores indicating greater depressive symptoms.
Measured: Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form
To measure anxiety. This measure assesses self-reported fear, worry, dread, hyperarousal, and somatic symptoms related to arousal over the past 7 days on a 1 (never) to 5 (always) scale. This scale includes 8 items with higher scores indicating greater anxiety symptoms.
Measured: Weekly up to 4 weeks
Relaxation Visual Analog Scale
To measure relaxation. Participants will be asked to rate their level of relaxation on a scale from 0 (Not Relaxed at All) to 10 (Very Relaxed). Higher scores will indicate greater relaxation.
Measured: Weekly up to 4 weeks
Self-report of medication use
Medication use measured by participants' daily self-report of medication use.
Measured: Daily up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start23 Feb 2021
- Primary completion3 Jul 2022
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary R. Elkins, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785963
- Sponsor's protocol ID
- 1863320-38
- Status last verified
- Jul 2023
- First submitted
- 25 Feb 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04785963
- Acronym / sponsor ID
- 1863320-38
- Conditions
- Low Back Pain, Chronic Pain, Sleep, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 3 Jul 2022 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 8 Mar 2021 (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 long-range goal is to reduce suffering and establish alternative options for older adults experiencing pain. This is a randomized controlled study examining the effect of music on pain management in older adults.
Detailed description
Study Objectives:
- Evaluate the efficacy of the music with suggestion intervention for chronic lower back pain in aging adults, with the indication that music with suggestion will significantly decrease subjective measures of pain compared to controls of music without suggestion or an informational recording about chronic pain.
- Evaluate the efficacy of the music with suggestion intervention for sleep in aging adults, with the indication that music with suggestion will significantly improve subjective measures of sleep compared to controls of music without suggestion or an informational recording about chronic pain.
- Evaluate the efficacy of the music with suggestion intervention for mood in aging adults, with the indication that music with suggestion will significantly improve subjective measures of mood compared to controls of music without suggestion or an informational recording about chronic pain.
Recruitment Plan
There will be 66 participants who wish to utilize mind-body interventions as treatment for chronic lower back pain.
The individual's eligibility will be determined using an Inclusion/Exclusion Criteria Screening Checklist containing the criteria listed above. If an individual appears to be eligible, he/she will be educated about the study purpose, procedures, and requirements. If the individual is interested in participating, they will sign a consent form, which may be signed through mail, through electronic platforms such as DocuSign, or in-person. The participant will be scheduled for their first formal education session and informed consent will take place during this session. This education session will take place through a video conference platform. All three groups will meet with a research staff member approximately five times (once during the education session and approximately once per week each following week) throughout the duration of the study. These sessions will take place through a video conference platform.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music with Suggestion | Experimental | Behavioral: Music with SuggestionActive condition where participants will be provided with recordings of pre-determined music in addition to recorded suggestions instructing the participant on how to listen to the music. |
| Music | Active comparator | Behavioral: Pain InformationControl group where participants will be provided recordings of pre-determined music |
| Pain Information | Active comparator | Behavioral: MusicNon-arts group receiving structured attention and standard care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be at least 50 years of age
- Participant must regularly experience moderate to severe chronic, lower back pain as determined by a self-reported pain rating of ≥ 5 on 11-point numerical rating scale
- Duration of pain must be ≥ 6 months
- Participant must be proficient and able to speak, read, and write in English
- Participant must have access to a computer or mobile device, Internet, and be willing to participate in virtual sessions and use electronic platforms to complete materials
Key exclusion criteria (4 listed)
- Presence of any psychiatric condition or symptom that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking
- History of mental illness (i.e., psychosis, schizophrenia)
- Non-English speaker
- Pain classified as neuropathic as detected by the Pain Detect Questionnaire
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 with SuggestionA nonpharmacological, short-term treatment that poses minimal risk and places very limited burden on patients seems ideal for this population, and music with suggestions is one such treatment option. | Behavioural | Music with Suggestion |
| Pain InformationThe comparison condition of informational recordings about chronic pain are structured to account for non-specific effects of general time and attention and to evaluate whether the treatments of music alone, and music in combination with suggestion are effective in the reduction of pain intensity more than an appropriate control group. | Behavioural | Music |
| MusicThe comparison condition of the music only is structured to account for the effect of music listening, and to evaluate whether the addition of suggestion optimizes its effectiveness in the reduction of pain intensity. | Behavioural | Pain Information |
Primary outcome
Pain Intensity Scale
Time frame: Daily
Subjective measures of pain intensity, which will be determined using a Pain Intensity Scale. This measure will be completed daily where participants will be asked to rate the intensity of their pain on a scale from 0 (No Pain) to 10 (Very Intense Pain). Higher scores will indicate greater pain intensity.
6 secondary outcomes
Pain Suffering Visual Analogue Scale (VAS)
Time frame: Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
Time frame: Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form
Time frame: Weekly up to 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form
Time frame: Weekly up to 4 weeks
Relaxation Visual Analog Scale
Time frame: Weekly up to 4 weeks
Self-report of medication use
Time frame: Daily up to 4 weeks
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 1 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 with Suggestion, Pain Information and Music in people with Low Back Pain and Chronic Pain, run by Baylor University 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 5 inclusion and 4 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 1 Aug 2023. 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?
Pain Intensity Scale (time frame: Daily). 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 1 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.