Chronic Low Back PainNCT06940063
Active Music-Based Intervention in Patients With Chronic Low Back Pain
A study testing Active music-based intervention in people with Chronic Low Back Pain, run by Sharon Wang-Price at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if active music-based intervention works to treat patients with chronic low back pain. The main questions it aims to answer are: 1. Does active music-based intervention improve cognitive function? 2. Does active music -based intervention improve sensitivity to stimuli? 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Active music-based intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18-65 years of age
- have chronic low back pain (CLBP) primarily in the L4-5 area. The CLBP is defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.
Who cannot join
- Participants will be excluded if their low back pain (LBP) is due to a non-musculoskeletal origin or they have any medical conditions that may affect the results:
- Previous back surgery
- Systemic arthritis (e.g., rheumatoid arthritis, psoriatic arthritis).
- Fracture of thoracic and lumbar spine, pelvis
- Infection
- Tumor
Show all 14Show fewer
- Traumatic brain injury
- Stroke
- Seizures/epilepsy
- Any other neurological disease (e.g., multiple sclerosis, muscular dystrophy, - Parkinson's)
- Circulation/vascular problems (e.g., Raynaud's)
- Cancer
- Uncontrolled diabetes/high blood sugar
- Currently pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Woman's University, Department of Music
Denton, Texas, 76204
Della Molloy-Daugherty, PhD, 214-898-2491, dmolloydaugherty@twu.edu
Sharon Wang-Price, PhD, 214-689-7715, swang@twu.edu
About this study
Official title: Does Active Music-Based Intervention Alter Cognitive Function, Sensitivity to Stimuli, Pain Catastrophizing and Quality of Life in Patients With Chronic Low Back Pain?
The goal of this clinical trial is to learn if active music-based intervention works to treat patients with chronic low back pain. The main questions it aims to answer are:
- Does active music-based intervention improve cognitive function?
- Does active music -based intervention improve sensitivity to stimuli?
- Does active music-based intervention improve pain catastrophizing behavior?
- Does active music-based intervention improve quality of life?
Participant will visit the clinic for 5 sessions of assessments and active music-based intervention over 2 weeks. On the first visit, it will take each participant 45 minutes to complete the pre-intervention assessments followed by a 45-minute active music-based intervention. The active music-based intervention will last about an hour for the remaining 4 visits. On the 5th or last visit, after the one-hour intervention, it will take another 30 minutes for each participant to complete the post-intervention assessments.
Read the detailed description
A prospective pre- and post-test research design will be used to compare outcome measures before and after the active music-based intervention (MBI) for the primary purpose of this study: to examine the effects of active MBI on cognitive function, sensitivity to stimuli, pain catastrophizing behavior and quality of life in individuals with chronic low back pain (CLBP). The secondary purpose of the study is to determine if there is a difference in cognitive function between participants with high vs. low levels of central sensitization, and to examine whether active music-based intervention (MBI) has differential effects on cognitive function and sensitivity to pressure stimuli.
After the eligible participants are enrolled in the study, each participant will be asked to complete an intake form to collect their demographic data (e.g., age, sex, race, height, weight, and occupation), past medical history, and questions related to their low back pain (onset, injury mechanism if any, location, duration, type, and nature). In addition, pain intensity and disability level will be determined using the Numerical Pain Rating Scale (NPRS) and the Modified Oswestry Low Back Pain Disability Questionnaire (OSW), respectively. The data collected will be used to describe the participants' characteristics of the study sample. Lastly, the severity of central sensitization will be determined by the Central Sensitization Inventory (CSI). A cutoff score of 33.5 from the CSI will be used to dichotomize the participants into the high vs. low level of CS. The target sample size is 40, 20 with a high level of central sensitization (CSI score of 33.5 or higher) and 20 with a low level of central sensitization (CSI score < 33.5).
Each participant will complete the outcome measurements before and after 5 sessions of active MBI. The primary outcome measures include cognitive tests, the pressure pain threshold (PPT) test, the Pain Catastrophizing Scale and the Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29) - see details in the Outcome Measure section.
There will be 5 intervention sessions. The first intervention will be administered after the outcome measure assessments and will last about 45 minutes. The other 4 intervention sessions will be one hour in length. During the first session, each participant will choose a preferred active musical experience in which they will engage for the entire study, including playing an instrument, singing, or songwriting. When the participants choose instrument playing or singing, they also will be given options to play a music piece or sing a song that they already know or that they can improvise. An example of improvisation is playing on a piano a piece of music which was written for violin.
All of the intervention sessions will be conducted by research assistants who are board-certified, credentialed music therapists. These researchers are trained in assessment, intervention planning, and treatment implementation. All of the intervention sessions will occur in a music therapy clinic at Texas Woman's University - Denton, Department of Music Therapy that is equipped with a wide variety of musical instruments, playback equipment, and ambient lighting.
- Conditions
- Chronic Low Back Pain
- Being tested
- Active music-based intervention
- Keywords
- Music therapy, Central sensitization, chronic low back pain, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active music-based interventionProcedure or surgery
Musical experience includes playing an instrument, singing, or songwriting.
| Study group | Role | What they receive |
|---|---|---|
| Active music-based in tervention | Experimental | Active musical interventions include playing an instrument, singing, or songwriting. Receives: Procedure: Active music-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Cognitive function will be assessed using the Stroop Color and Word Test (SCWT).
The SCWT is used to measure a person's attentional interference or the ability to inhibit the interference of a second stimulus while continuing to process an original stimulus. A computerized version of the SCWT via a software program DirectRT (Empirisoft Corp., New York, NY) will be used. The SCWT consists of 3 parts, each containing 24 consecutive stimuli. A reaction time will be computed in software based on the speed of the participant's response.
Measured: This outcome measure (SCWT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Cognitive function
Cognitive function will be assessed using the Comprehensive Trail Making Test - Second Edition (CTMT2).
The CTMT2 consists of 5 trails requiring cognitive control between competing stimuli and schemas. Trails 1-3 measure inhibitory control by completing trails with increasing numbers of distractors. Trails 4-5 measure set-shifting by requiring participants to shift between opposing mental sets (i.e., numbers and letters). The test will use standardized instructions.
Measured: This outcome measure (CTMT2) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Secondary outcomes (3)
Sensitivity to stimuli
Pressure pain threshold (PPT) will be used to determine the level of sensitivity to stimuli using a hand-held computerized pressure algometer (Medoc ltd., Ramat Yishai, Israel). The algometer will be pressed vertically on the most tender point of the participant's low back. To provoke the participant's pain or discomfort, pressure will be increased at a rate of 40 kPa/sec until the participant feels pain as indicated by pressing the patient safety button. Three trials of PPT testing will be administered.
Measured: This outcome measure (PPT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Pain catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item questionnaire that requires the participants to select their level of agreement for each item on a 5-point Likert scale. The total score ranges from 0-52, with a higher score indicating greater levels of pain catastrophizing
Measured: This outcome measure (PCS) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Health-related Quality of life
Health-related quality of life will be determined by the Patient-Reported Outcomes Measurement Information System -29 (PROMIS-29). The PROMIS-29 is a 29-item questionnaire that assesses general health-related quality of life across 7 domains (i.e., physical function, pain interference, anxiety, depression, fatigue, sleep disturbance, and social roles) and pain intensity.
Measured: This outcome measure (PROMIS-29) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start7 Aug 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trial with a single arm.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharon Wang-Price
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Woman's University
- Responsible party
- Sponsor-investigator, Sharon Wang-Price, Texas Woman's University
- Investigators
- Sharon Wang-Price, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940063
- Sponsor's protocol ID
- IRB-FY2025-89
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD raises ethical concerns about participant privacy and the potential for misuse of sensitivity data. Data protection laws and regulations can restrict the sharing of personal data, even for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Active Music-Based Intervention Alter Cognitive Function, Sensitivity to Stimuli, Pain Catastrophizing and Quality of Life in Patients With Chronic Low Back Pain?
- ClinicalTrials.gov ID
- NCT06940063
- Acronym / sponsor ID
- IRB-FY2025-89
- Conditions
- Chronic Low Back Pain
- Keywords
- Music therapy, Central sensitization, chronic low back pain, cognitive function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sharon Wang-PriceUniversity, hospital or other
- Collaborators
- Texas Woman's University
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 Apr 2025 (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 goal of this clinical trial is to learn if active music-based intervention works to treat patients with chronic low back pain. The main questions it aims to answer are:
- Does active music-based intervention improve cognitive function?
- Does active music -based intervention improve sensitivity to stimuli?
- Does active music-based intervention improve pain catastrophizing behavior?
- Does active music-based intervention improve quality of life?
Participant will visit the clinic for 5 sessions of assessments and active music-based intervention over 2 weeks. On the first visit, it will take each participant 45 minutes to complete the pre-intervention assessments followed by a 45-minute active music-based intervention. The active music-based intervention will last about an hour for the remaining 4 visits. On the 5th or last visit, after the one-hour intervention, it will take another 30 minutes for each participant to complete the post-intervention assessments.
Detailed description
A prospective pre- and post-test research design will be used to compare outcome measures before and after the active music-based intervention (MBI) for the primary purpose of this study: to examine the effects of active MBI on cognitive function, sensitivity to stimuli, pain catastrophizing behavior and quality of life in individuals with chronic low back pain (CLBP). The secondary purpose of the study is to determine if there is a difference in cognitive function between participants with high vs. low levels of central sensitization, and to examine whether active music-based intervention (MBI) has differential effects on cognitive function and sensitivity to pressure stimuli.
After the eligible participants are enrolled in the study, each participant will be asked to complete an intake form to collect their demographic data (e.g., age, sex, race, height, weight, and occupation), past medical history, and questions related to their low back pain (onset, injury mechanism if any, location, duration, type, and nature). In addition, pain intensity and disability level will be determined using the Numerical Pain Rating Scale (NPRS) and the Modified Oswestry Low Back Pain Disability Questionnaire (OSW), respectively. The data collected will be used to describe the participants' characteristics of the study sample. Lastly, the severity of central sensitization will be determined by the Central Sensitization Inventory (CSI). A cutoff score of 33.5 from the CSI will be used to dichotomize the participants into the high vs. low level of CS. The target sample size is 40, 20 with a high level of central sensitization (CSI score of 33.5 or higher) and 20 with a low level of central sensitization (CSI score < 33.5).
Each participant will complete the outcome measurements before and after 5 sessions of active MBI. The primary outcome measures include cognitive tests, the pressure pain threshold (PPT) test, the Pain Catastrophizing Scale and the Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29) - see details in the Outcome Measure section.
There will be 5 intervention sessions. The first intervention will be administered after the outcome measure assessments and will last about 45 minutes. The other 4 intervention sessions will be one hour in length. During the first session, each participant will choose a preferred active musical experience in which they will engage for the entire study, including playing an instrument, singing, or songwriting. When the participants choose instrument playing or singing, they also will be given options to play a music piece or sing a song that they already know or that they can improvise. An example of improvisation is playing on a piano a piece of music which was written for violin.
All of the intervention sessions will be conducted by research assistants who are board-certified, credentialed music therapists. These researchers are trained in assessment, intervention planning, and treatment implementation. All of the intervention sessions will occur in a music therapy clinic at Texas Woman's University - Denton, Department of Music Therapy that is equipped with a wide variety of musical instruments, playback equipment, and ambient lighting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trial with a single arm.
| Arm | Type | Receives |
|---|---|---|
| Active music-based in tervention | Experimental | Procedure: Active music-based interventionActive musical interventions include playing an instrument, singing, or songwriting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults 18-65 years of age
- have chronic low back pain (CLBP) primarily in the L4-5 area. The CLBP is defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.
Key exclusion criteria (14 listed)
- Participants will be excluded if their low back pain (LBP) is due to a non-musculoskeletal origin or they have any medical conditions that may affect the results:
- Previous back surgery
- Systemic arthritis (e.g., rheumatoid arthritis, psoriatic arthritis).
- Fracture of thoracic and lumbar spine, pelvis
- Infection
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 |
|---|---|---|
| Active music-based interventionMusical experience includes playing an instrument, singing, or songwriting. | Procedure or surgery | Active music-based in tervention |
Primary outcome
Cognitive function
Time frame: This outcome measure (SCWT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Cognitive function will be assessed using the Stroop Color and Word Test (SCWT). The SCWT is used to measure a person's attentional interference or the ability to inhibit the interference of a second stimulus while continuing to process an original stimulus. A computerized version of the SCWT via a software program DirectRT (Empirisoft Corp., New York, NY) will be used. The SCWT consists of 3 parts, each containing 24 consecutive stimuli. A reaction time will be computed in software based on the speed of the participant's response.
Cognitive function
Time frame: This outcome measure (CTMT2) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Cognitive function will be assessed using the Comprehensive Trail Making Test - Second Edition (CTMT2). The CTMT2 consists of 5 trails requiring cognitive control between competing stimuli and schemas. Trails 1-3 measure inhibitory control by completing trails with increasing numbers of distractors. Trails 4-5 measure set-shifting by requiring participants to shift between opposing mental sets (i.e., numbers and letters). The test will use standardized instructions.
3 secondary outcomes
Sensitivity to stimuli
Time frame: This outcome measure (PPT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Pain catastrophizing
Time frame: This outcome measure (PCS) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Health-related Quality of life
Time frame: This outcome measure (PROMIS-29) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No. Sharing IPD raises ethical concerns about participant privacy and the potential for misuse of sensitivity data. Data protection laws and regulations can restrict the sharing of personal data, even for research purposes.
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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.
Sharon Wang-Price, PhD principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active music-based intervention in people with Chronic Low Back Pain, run by Sharon Wang-Price 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 2 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Wang-Price, PhD (1 214-689-7725, swang@twu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: This outcome measure (SCWT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.). The study lists 2 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 9 Jan 2026.