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临床试验/NCT05667168
NCT05667168Enrolling By Invitation不适用

Physiotherapeutic Diagnostic and Therapy of Tinnitus

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
400
试验地点
1
主要终点
Decreasing of sensoric feeling of tinnitus.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

The participants and care providers will not know the checking data.

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Decreasing of sensoric feeling of tinnitus.

时间窗: 3 month

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.

时间窗: 3 month

According to the questionnaire survey (THI) the effect of the treatment will be shown.

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malá Jitka

Clincial Professor

Charles University, Czech Republic

研究点 (1)

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