SOMATINMultimodal Treatment for Somatosensory Tinnitus: Physiotherapy, Exercise, and Psychological Intervention
This study aims to evaluate the effectiveness of a multimodal treatment, combining physiotherapy, exercise, and psychological intervention, in reducing the impact of tinnitus on your daily life, as measured by the Tinnitus Handicap Inventory (THI) score.
Multimodal physiotherapy for TMJ and Cervical spine
+ Combined Exercise Program (Aerobic + Resistance + Breathing)
+ Tinnitus-Specific Psychological Support
Brain Diseases+19
+ Central Nervous System Diseases
+ Ear Diseases
Treatment Study
Summary
Study start date: January 1, 2027
Actual date on which the first participant was enrolled.This study focuses on a specific type of tinnitus, known as somatosensory tinnitus, where the ringing in the ears is influenced by movements like jaw clenching, neck rotation, or trigger point pressure. The aim is to explore a multimodal treatment approach that combines physiotherapy, a structured exercise program, and psychological intervention. This research is important as it addresses a gap in clinical practice in the Czech Republic, despite evidence suggesting the effectiveness of such multimodal approaches for this condition. The study involves a single-centre randomized controlled trial with a longitudinal follow-up and a crossover substudy. Participants will engage in an 8-week program that includes physiotherapy sessions, a supervised and home-based exercise program, and psychological support. The physiotherapy involves manual therapy of the jaw and neck, while the exercise program combines aerobic, resistance, and relaxation training. The psychological support includes a group psychoeducation session, weekly self-help materials, and on-demand psychological support. The primary outcome measured is the change in tinnitus-related handicap using the Tinnitus Handicap Inventory (THI) score from baseline to 3, 12, and 24 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Charles University Faculty of physical education and sport
Prague, CzechiaOpen Charles University Faculty of physical education and sport in Google Maps