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

NCT03776019 | Completed DMC

• 1 other identifier: AVWF 2019
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Stress

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Health related quality of life

  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

  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

  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

  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

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

Study Arms (2)

Modulated

EXPERIMENTAL

modulated music

Device: AVWF device

Typical

SHAM COMPARATOR

typical music

Device: AVWF device

Interventions

AVWF device DEVICE

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

Modulated; Typical

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic low back pain with a numeric rating scale of pain \>= 4 for \> 6 month
• patients \>18 years

You may not qualify if:

• psychosis
• drug addiction
• pension process
• pregnant women
• epilepsy

Sponsors & Collaborators

• Klinikum Klagenfurt am Wörthersee: lead

Study Sites (1)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudolf Likar

  Head of department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim.Univ.Prof.Dr.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 14, 2018
• Study Start: February 15, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)