- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776019
Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients
September 8, 2020 updated by: Rudolf Likar, Klinikum Klagenfurt am Wörthersee
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
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Klagenfurt, Austria, 9020
- Klinikum Klagenfurt am Wörthersee
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Modulated
modulated music
|
The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.
|
SHAM_COMPARATOR: Typical
typical music
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
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A 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.
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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
Time Frame: Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
|
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
Time Frame: Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
|
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
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rudolf Likar, head of department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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