Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05667168 |
| Other study ID # |
FTVS |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
August 30, 2025 |
Study information
| Verified date |
December 2022 |
| Source |
Charles University, Czech Republic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
