PainNCT03776019
Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients
A study testing AVWF device in people with Pain and Stress, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- AVWF device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteAustria
- Study dates
- 15 Feb 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain with a numeric rating scale of pain >= 4 for > 6 month
- patients >18 years
Who cannot join
- psychosis
- drug addiction
- pension process
- pregnant women
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- AVWF device
- Keywords
- Pain, Stress, AVWF, Audio-Visual-Perception-Enhancement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVWF deviceDevice
The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Modulated | Experimental | modulated music Receives: Device: AVWF device |
| Typical | Sham comparator | typical music Receives: Device: AVWF device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (6)
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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start15 Feb 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Klagenfurt am Wörthersee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudolf Likar, Klinikum Klagenfurt am Wörthersee
- Investigators
- Rudolf Likar, Principal investigator, Head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776019
- Sponsor's protocol ID
- AVWF 2019
- Status last verified
- Sep 2020
- First submitted
- 10 Dec 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03776019
- Acronym / sponsor ID
- AVWF 2019
- Keywords
- Pain, Stress, AVWF, Audio-Visual-Perception-Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Klinikum Klagenfurt am WörtherseeUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modulated | Experimental | Device: AVWF devicemodulated music |
| Typical | Sham comparator | Device: AVWF devicetypical music |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic low back pain with a numeric rating scale of pain >= 4 for > 6 month
- patients >18 years
Key exclusion criteria (5 listed)
- psychosis
- drug addiction
- pension process
- pregnant women
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVWF deviceThe AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve. | Device | Modulated, Typical |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf Likar principal investigator
Head of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVWF device in people with Pain and Stress, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.