Physiotherapeutic Approach to Tinnitus

Charles University, Czech Republic

Status: Invitation-only

Conditions: Tinnitus

Treatments: Procedure: physiotherapy approach

Study type: Interventional

Funder types: Other

Identifiers

NCT05667168

FTVS

Details and patient eligibility

About

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.

Full description

Clients will be divided into individual (8) therapy groups. The proband groups formed will be treated by individual researchers according to a similar methodology, each with a different therapeutic intervention for tinnitus. The main dominant variables to be monitored will be tinnitus intensity assessed on a visual numerical scale from 0-10, and quality of life observed using different questionnaires (which questionnaires will be used will be addressed in the course of the research, as this is not standardly used for tinnitus in the Czech region). The questionnaires will measure the quality of life and intensity of tinnitus of probands at the beginning and the end of the experiment, regardless of their racial, political, social, religious, and philosophical views and classification. Sexual orientation and criminal offences will not be questioned or addressed. As part of the questionnaires, clients will be subjected to musculoskeletal diagnosis by kinesiological analysis and tinnitus diagnosis by examination and will be further assigned to appropriate therapy sections (8). The questionnaires will be given to probands in hard copy at the initial assessment, during which the proband will complete and submit the questionnaire. The exit questionnaire will be administered similarly at the exit examination, i.e. the proband's last visit to the research team.

The selected therapeutic interventions in each section will be a low-power laser, high-power laser, radiofrequency therapy, manual therapy of the temporomandibular joint, manual treatment of the cervical and adjacent thoracic spine, myofascial chain work in the context of closed and open kinematic patterns, psychological guidance mediated by a psychosomatic physician, and addressing healthy lifestyle issues. The therapy will take place 2-3 times a week; the therapeutic unit will be 45 min and will be oriented to 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). The therapy will take place at the clinical workplace of private practice (anonymise) and the practice rooms of the Department of Physiotherapy Faculty of Physiotherapy of Charles University. At the end 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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400 participants in 8 patient groups, including a placebo group

High power laser

Experimental group

Description:

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.

Treatment:

Procedure: physiotherapy approach

Low power laser

Experimental group

Description:

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.

Treatment:

Procedure: physiotherapy approach

Radio-frequention therapy

Experimental group

Description:

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.

Treatment:

Procedure: physiotherapy approach

Manual therapy of temporomandibular joint,.

Experimental group

Description:

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

Treatment:

Procedure: physiotherapy approach

Manual therapy of the cervical spine.

Experimental group

Description:

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

Treatment:

Procedure: physiotherapy approach

Physical exercising.

Active Comparator group

Description:

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.

Treatment:

Procedure: physiotherapy approach

Cognitive therapy

Active Comparator group

Description:

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

Treatment:

Procedure: physiotherapy approach

Life style.

Placebo Comparator group

Description:

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

Treatment:

Procedure: physiotherapy approach