Back to results

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

Primary Purpose

Pain, Stress

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

AVWF device

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Stress, AVWF, Audio-Visual-Perception-Enhancement

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinikum Klagenfurt am Wörthersee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Modulated

Typical

Arm Description

modulated music

typical music

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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).

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

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.

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

Salival Cortisol level

Immunoassay for in vitro quantitative determination of cortisol in saliva

Full Information

NCT ID

NCT03776019

First Posted

December 10, 2018

Last Updated

September 8, 2020

Sponsor

Klinikum Klagenfurt am Wörthersee

1. Study Identification

Unique Protocol Identification Number

NCT03776019

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

February 15, 2019 (Actual)

Primary Completion Date

December 20, 2019 (Actual)

Study Completion Date

December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Klinikum Klagenfurt am Wörthersee

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Stress

Keywords

Pain, Stress, AVWF, Audio-Visual-Perception-Enhancement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modulated

Arm Type

Experimental

Arm Description

modulated music

Arm Title

Typical

Arm Type

Sham Comparator

Arm Description

typical music

Intervention Type

Device

Intervention Name(s)

AVWF device

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Numeric Rating Scale of Pain Severity

Description

Time Frame

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 Measure Information:

Title

Health related quality of life

Description

Health related quality of life will be measured by euroQol-5D questionnaire. It contains two sections, a descriptive section and a valuation section

Time Frame

Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention

Title

Hospital Anxiety and Depression Scale

Description

Time Frame

Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention

Title

Pittsburgh Sleep Quality Index

Description

Self-report questionnaire that assesses sleep Quality through the measure of 19 individual items, creating 7 components that produce one global score

Time Frame

Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention

Title

Depression Anxiety Stress Scales

Description

A 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.

Time Frame

Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention

Title

Pain Disability Index

Description

Time Frame

Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention

Title

Salival Cortisol level

Description

Immunoassay for in vitro quantitative determination of cortisol in saliva

Time Frame

Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudolf Likar

Organizational Affiliation

Head of department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum Klagenfurt am Wörthersee

City

Klagenfurt

ZIP/Postal Code

9020

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs