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Music-Based Intervention for Chronic Low Back Pain

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What is being tested

Active music-based intervention

Procedure
Who is being recruted

Back Pain
+1

+ Neurologic Manifestations
+ Pain
From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorSharon Wang-Price
Study ContactSharon Wang-Price, PhDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2025Actual date on which the first participant was enrolled.

This clinical trial aims to explore how an active music-based intervention can influence various aspects of life for people suffering from chronic low back pain. Specifically, the study examines whether engaging in musical activities can improve cognitive function, reduce sensitivity to stimuli, lower pain-related anxiety, and enhance overall quality of life. Participants are divided based on their levels of central sensitization, which refers to the nervous system's heightened response to pain. This research is significant as it investigates non-traditional methods that might offer relief and improve life quality for those with persistent back pain. Participants in this study will attend five music-based sessions, where they can choose to engage in activities such as playing an instrument, singing, or songwriting. These sessions are conducted by trained music therapists in a well-equipped clinic. Before and after these sessions, participants will complete various tests to assess changes in cognitive abilities, pain sensitivity, and emotional responses to pain. The study collects initial information on demographics and pain characteristics, using tools like the Numerical Pain Rating Scale and the Central Sensitization Inventory to categorize participants. This approach helps determine the effectiveness of music therapy in managing chronic low back pain.

Official TitleDoes Active Music-Based Intervention Alter Cognitive Function, Sensitivity to Stimuli, Pain Catastrophizing and Quality of Life in Patients With Chronic Low Back Pain? 
NCT06940063
Principal SponsorSharon Wang-Price
Study ContactSharon Wang-Price, PhDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Back Pain
Neurologic Manifestations
Pain
Low Back Pain
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Active musical interventions include playing an instrument, singing, or songwriting.

Musical experience includes playing an instrument, singing, or songwriting.
Study Objectives
Primary Objectives

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 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.
Secondary Objectives

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.

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

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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