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Completed

NCT Number: NCT03776019

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVWF device

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. 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

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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Klinikum Klagenfurt am Wörthersee

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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