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Physiotherapeutic Approach to Tinnitus

Primary Purpose

Tinnitus

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
physiotherapy approach
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tinnitus focused on measuring headache, noise, laser, manual therapy, temporomandibular dysfunction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charles University, Faculty of physical education and sport

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

High power laser

Low power laser

Radio-frequention therapy

Manual therapy of temporomandibular joint,.

Manual therapy of the cervical spine.

Physical exercising.

Cognitive therapy

Life style.

Arm 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.

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.

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.

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

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

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.

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

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

Outcomes

Primary Outcome Measures

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.
Changing of life quality due to tinnitus.
According to the questionnaire survey (THI) the effect of the treatment will be shown.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
March 1, 2023
Sponsor
Charles University, Czech Republic
Collaborators
The Jerzy Kukuczka Academy of Physical Education in Katowice
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1. Study Identification

Unique Protocol Identification Number
NCT05667168
Brief Title
Physiotherapeutic Approach to Tinnitus
Official Title
Physiotherapeutic Diagnostic and Therapy of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 25, 2023 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
The Jerzy Kukuczka Academy of Physical Education in Katowice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
headache, noise, laser, manual therapy, temporomandibular dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
intervention study
Masking
ParticipantCare Provider
Masking Description
The participants and care providers will not know the checking data.
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High power laser
Arm Type
Experimental
Arm 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.
Arm Title
Low power laser
Arm Type
Experimental
Arm 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.
Arm Title
Radio-frequention therapy
Arm Type
Experimental
Arm 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.
Arm Title
Manual therapy of temporomandibular joint,.
Arm Type
Experimental
Arm Description
A manual physiotherapeutic approach to the temporomandibular joint will treat participants. Administration of tinnitus intensity on a scale of 0-10 and questionary.
Arm Title
Manual therapy of the cervical spine.
Arm Type
Experimental
Arm Description
A manual physiotherapeutic approach to the cervical spine will treat participants. Administration of tinnitus intensity on a scale of 0-10 and questionary.
Arm Title
Physical exercising.
Arm Type
Active Comparator
Arm 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.
Arm Title
Cognitive therapy
Arm Type
Active Comparator
Arm Description
Participants will be treated with cognitive therapy by a psychologist. Administration of tinnitus intensity on a scale of 0-10 and questionary.
Arm Title
Life style.
Arm Type
Placebo Comparator
Arm Description
Participants will be treated only by modulation of their lifestyle. Administration of tinnitus intensity on a scale of 0-10 and questionary.
Intervention Type
Procedure
Intervention Name(s)
physiotherapy approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decreasing of sensoric feeling of tinnitus.
Description
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.
Time Frame
3 month
Title
Changing of life quality due to tinnitus.
Description
According to the questionnaire survey (THI) the effect of the treatment will be shown.
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jitka Malá, PhD.
Organizational Affiliation
Charles University Prague, Czech Republic
Official's Role
Study Director
Facility Information:
Facility Name
Charles University, Faculty of physical education and sport
City
Praha
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

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Physiotherapeutic Approach to Tinnitus

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