Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients

Study Overview
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Brief Summary
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It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain reduction and a decrease of inflammatory markers in chronic pain patients. Also an improvement of quality of life, self-perceived disability and depression in chronic pain patients is expected.

Official Title
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Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients

Conditions
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Pain, Stress

Intervention / Treatment
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* Device: AVWF device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic low back pain with a numeric rating scale of pain >= 4 for > 6 month patients >18 years Exclusion Criteria: psychosis drug addiction pension process pregnant women epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modulated<br>modulated music | Device: AVWF device<br>* The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.<br>|
| Sham Comparator: Typical<br>typical music | Device: AVWF device<br>* The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Rating Scale of Pain Severity | Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain Level. | Change from baseline Numeric Rating Scale of Pain Severity after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Health related quality of life will be measured by euroQol-5D questionnaire. It contains two sections, a descriptive section and a valuation section | Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 
| Hospital Anxiety and Depression Scale | Anxiety and depression is evaluated by the the Hospital Anxiety and Depression Scale.It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items). It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress). | Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 
| Pittsburgh Sleep Quality Index | Self-report questionnaire that assesses sleep Quality through the measure of 19 individual items, creating 7 components that produce one global score | Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 
| Depression Anxiety Stress Scales | A 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. | Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 
| Pain Disability Index | The Pain Disability Index is an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Minimal index: 0; maximal index: 70; The higher the index the greater the person's disability due to pain | Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 
| Salival Cortisol level | Immunoassay for in vitro quantitative determination of cortisol in saliva | Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Stress, AVWF, Audio-Visual-Perception-Enhancement