Physiotherapeutic Approach to Tinnitus

NCT05667168 | Unknown

• 1 other identifier: FTVS
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Intervention experiments in the physiotherapeutic field targeted diagnostics and therapy of tinnitus. The goal is to find various groups of tinnitus patients and an ideal therapeutic approach between physical therapy means, manual techniques and physical education approach.

Conditions

Tinnitus

Keywords

headache; noise; laser; manual therapy; temporomandibular dysfunction

Outcome Measures

Primary Outcomes (2)

• Decreasing of sensoric feeling of tinnitus.

  Due to analog numeric scale (0-10 where 0 mean without tinnitus and 10 maximum intensity of tinnitus), will be find the most effective approach to decreasing hearable sound typical for tinnitus.

  3 month

• Changing of life quality due to tinnitus.

  According to the questionnaire survey (THI) the effect of the treatment will be shown.

  3 month

Study Arms (8)

High power laser

EXPERIMENTAL

The application of high-intensity laser on cervical muscles, 50J/cm2, 980nm, 0 Hz, on processus mastoideus and porus acusticus externus. Administration of tinnitus intensity on scale 0-10 and questionary.

Procedure: physiotherapy approach

Low power laser

EXPERIMENTAL

The application of low-intensity laser on cervical muscles, 4J/cm2, 980nm, 0 Hz, on processus mastoideus and porus acusticus externus. Administration of tinnitus intensity on scale 0-10 and questionary.

Procedure: physiotherapy approach

Radio-frequention therapy

EXPERIMENTAL

Applying radio-frequentation current on cervical muscles, 10-50% of intensity, 0 Hz. Administration of tinnitus intensity on a scale of 0-10 and questionary.

Procedure: physiotherapy approach

Manual therapy of temporomandibular joint,.

EXPERIMENTAL

A manual physiotherapeutic approach to the temporomandibular joint will treat participants. Administration of tinnitus intensity on a scale of 0-10 and questionary.

Procedure: physiotherapy approach

Manual therapy of the cervical spine.

EXPERIMENTAL

A manual physiotherapeutic approach to the cervical spine will treat participants. Administration of tinnitus intensity on a scale of 0-10 and questionary.

Procedure: physiotherapy approach

Physical exercising.

ACTIVE COMPARATOR

Participants will be treated by physical exercising in closing and opening muscle chains. Administration of tinnitus intensity on a scale of 0-10 and questionary.

Procedure: physiotherapy approach

Cognitive therapy

ACTIVE COMPARATOR

Participants will be treated with cognitive therapy by a psychologist. Administration of tinnitus intensity on a scale of 0-10 and questionary.

Procedure: physiotherapy approach

Life style.

PLACEBO COMPARATOR

Participants will be treated only by modulation of their lifestyle. Administration of tinnitus intensity on a scale of 0-10 and questionary.

Procedure: physiotherapy approach

Interventions

physiotherapy approach PROCEDURE

The therapy will take place 2-3 times a week; the therapeutic unit will last 45 minutes and will be oriented towards one therapeutic approach from the above list. The total number of therapy sessions will be limited to 3 months (i.e. three months, 2-3 times a week). After completion of the 3-month therapy, a follow-up examination will be performed again by kinesiological analysis, questions about the intensity of tinnitus according to a numerical scale and quality of life by a selected questionnaire.

Cognitive therapy; High power laser; Life style.; Low power laser; Manual therapy of temporomandibular joint,.; Manual therapy of the cervical spine.; Physical exercising.; Radio-frequention therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• neurologically diagnosed tinnitus
• age 20-80 years
• tinnitus of any nature persisting for more than 3 months

You may not qualify if:

• acute or chronic medical conditions requiring medication
• history of head and cervical spine trauma
• oncologic therapy
• psychological or psychiatric treatment

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• The Jerzy Kukuczka Academy of Physical Education in Katowice: collaborator

Study Sites (1)

Charles University, Faculty of physical education and sport

Prague, Czechia

Location

MeSH Terms

Conditions

Tinnitus; Headache; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Jitka Malá, PhD.

  Charles University Prague, Czech Republic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants and care providers will not know the checking data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clincial Professor

Model Details: intervention study

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: November 1, 2022
• Primary Completion: April 25, 2023
• Study Completion: August 30, 2025
• Last Updated: March 2, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)