Physiotherapeutic Approach to Tinnitus

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05667168
Collaborator
(none)
400
1
8
33.9
11.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: physiotherapy approach
N/A

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, TRT or 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 Rehamil (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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
intervention studyintervention study
Masking:
Double (Participant, Care Provider)
Masking Description:
The participants and care providers will not know the checking data.
Primary Purpose:
Supportive Care
Official Title:
Physiotherapeutic Diagnostic and Therapy of Tinnitus
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Apr 25, 2023
Anticipated Study Completion Date :
Aug 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: High power laser

Participants will be treated by high-power laser application.

Procedure: physiotherapy approach
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.

Experimental: Low power laser

Participants will be treated by low-power laser application.

Procedure: physiotherapy approach
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.

Experimental: Radiofrequention therapy

Participants will be treated by Targeted radiofrequention therapy.

Procedure: physiotherapy approach
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.

Experimental: Manual therapy of temporomandibular joint,.

A manual physiotherapeutic approach to the temporomandibular joint will treat participants.

Procedure: physiotherapy approach
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.

Experimental: Manual therapy of the cervical spine.

A manual physiotherapeutic approach to the cervical spine will treat participants.

Procedure: physiotherapy approach
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.

Active Comparator: Physical exercising.

Participants will be treated by physical exercising in closing and opening muscle chains.

Procedure: physiotherapy approach
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.

Active Comparator: Cognitive therapy

Participants will be treated with cognitive therapy by a psychologist.

Procedure: physiotherapy approach
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.

Placebo Comparator: Life style.

Participants will be treated only by modulation of their lifestyle.

Procedure: physiotherapy approach
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.

Outcome Measures

Primary Outcome Measures

  1. Decreasing of sensoric feeling of tinnius. [3 month]

    Due to analog numeric scale will be find the most effective approach to decreasing hearable sound typical for tinnitus.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

neurologically diagnosed tinnitus, voluntary participation in the study, 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, psychological or psychiatric treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charles University, Faculty of physical education and sport Praha Czechia

Sponsors and Collaborators

  • Charles University, Czech Republic

Investigators

  • Study Director: Jitka Malá, PhD., Charles University Prague, Czech Republic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Malá Jitka, PhDr.Jitka Malá, Ph.D., Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT05667168
Other Study ID Numbers:
  • FTVS
First Posted:
Dec 28, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Malá Jitka, PhDr.Jitka Malá, Ph.D., Charles University, Czech Republic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2022