Active Music-Based Intervention in Patients With Chronic Low Back Pain

NCT06940063 | Recruiting

• 1 other identifier: IRB-FY2025-89
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Does active music-based intervention improve cognitive function?
2. 2.Does active music -based intervention improve sensitivity to stimuli?
3. 3.Does active music-based intervention improve pain catastrophizing behavior?
4. 4.Does active music-based intervention improve quality of life?

Conditions

Chronic Low Back Pain

Keywords

Music therapy; Central sensitization; chronic low back pain; cognitive function

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  This outcome measure (PPT) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.

• Pain catastrophizing

  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

  This outcome measure (PROMIS-29) will be administered twice, before the start of treatment and after the end of treatment at 2 weeks.

Study Arms (1)

Active music-based in tervention

EXPERIMENTAL

Active musical interventions include playing an instrument, singing, or songwriting.

Procedure: Active music-based intervention

Interventions

Active music-based intervention PROCEDURE

Musical experience includes playing an instrument, singing, or songwriting.

Active music-based in tervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Woman's University: collaborator
• Sharon Wang-Price: lead

Study Sites (1)

Texas Woman's University, Department of Music

Denton, Texas, 76204, United States

RECRUITING

Study Officials

• Sharon Wang-Price, PhD

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Wang-Price, PhD

CONTACT

1 214-689-7725; swang@twu.edu

Della Molloy-Daugherty, PhD

CONTACT

1 940-898-2491; swang@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor/Faculty

Model Details: Clinical trial with a single arm.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 23, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)