NCT06940063 · Sharon Wang-Price
Active Music-Based Intervention in Patients With Chronic Low Back Pain
What this study is about
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. Does active music-based intervention improve pain catastrophizing behavior? 4.
View original scientific description
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. Does active music-based intervention improve pain catastrophizing behavior? 4. 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.
Interventions
PROCEDURE
Active music-based intervention
Musical experience includes playing an instrument, singing, or songwriting.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Traumatic brain injury
- Seizures/epilepsy
- Any other neurological disease (e.g., multiple sclerosis, muscular dystrophy, - Parkinson's)
- Circulation/vascular problems (e.g., Raynaud's)
- Uncontrolled diabetes/high blood sugar
- Currently pregnant
Where
- Denton, Texas
Collaborators
Texas Woman's University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2026 · Source of record for eligibility and locations