Clinical trial NCT06940063: Active Music-Based Intervention in Patients With Chronic Low Back Pain
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?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Music therapy
Central sensitization
chronic low back pain
cognitive function
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Texas Woman's University
First posted: 2025-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trial with a single arm.
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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
* Infection
* Tumor
* 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

Primary outcomes:
measure: Cognitive function
timeFrame: This outcome measure (SCWT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
measure: Cognitive function
timeFrame: This outcome measure (CTMT2) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Secondary outcomes:
measure: Sensitivity to stimuli
timeFrame: This outcome measure (PPT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
measure: Pain catastrophizing
timeFrame: This outcome measure (PCS) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
measure: Health-related Quality of life
timeFrame: This outcome measure (PROMIS-29) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Texas Woman's University
name: Sharon Wang-Price, PhD
role: PRINCIPAL_INVESTIGATOR
References: