Clinical trial NCT05667168: Physiotherapeutic Approach to Tinnitus
Official title: Physiotherapeutic Diagnostic and Therapy of Tinnitus
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tinnitus
Keywords: headache
noise
laser
manual therapy
temporomandibular dysfunction
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: The Jerzy Kukuczka Academy of Physical Education in Katowice
First posted: 2022-12-28
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: intervention study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Decreasing of sensoric feeling of tinnitus.
timeFrame: 3 month
measure: Changing of life quality due to tinnitus.
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Charles University, Faculty of physical education and sport
Study officials:
affiliation: Charles University Prague, Czech Republic
name: Jitka Malá, PhD.
role: STUDY_DIRECTOR
References: