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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Stress
• Intervention / Treatment: Device: AVWF device

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Modulated; modulated music	Device: AVWF device; The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.
SHAM_COMPARATOR: Typical; typical music	Device: AVWF device; The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Klinikum Klagenfurt am Wörthersee
• Investigators: Principal Investigator: Rudolf Likar, Head of Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): December 20, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (ACTUAL): December 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Stress; AVWF; Audio-Visual-Perception-Enhancement
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: AVWF 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No