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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776019
• Other study ID #: AVWF 2019
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: September 2020
• Source: Klinikum Klagenfurt am Wörthersee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain
• Stress

Intervention

Device:
• AVWF device
The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Klagenfurt am Wörthersee

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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