CompletedNot Applicable

Effects of Osteopathic Treatment in Patients With Somatosensory Tinnitus

Brazil54 participantsStarted 2022-09-02

Plain-language summary

The aim of this clinical trial is to evaluate whether osteopathic treatment is effective in reducing the discomfort and magnitude of tinnitus symptoms in individuals with somatosensory tinnitus. In addition, the study seeks to investigate whether this approach promotes measurable changes in clinical and audiological outcomes. The main questions it aims to answer are: * Does osteopathic treatment reduce the intensity and impact of tinnitus perceived by participants? * Does osteopathic treatment promote changes in audiological and functional measures related to tinnitus? Researchers will compare osteopathic treatment to a sham treatment group to verify if the observed effects are specific to the intervention. Participants will be required to: * Participate in osteopathic treatment sessions or sham treatment throughout the study period. * Undergo clinical and audiological assessments before and after the interventions. * Answer questionnaires related to the perception and impact of tinnitus on quality of life.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Patients with unilateral or bilateral tinnitus for at least 6 months; * Both sexes; * Age over 18 years; * Present modulation, that is, perceive changes in the psychoacoustic characteristics of the tinnitus (intensity, frequency and/or location) in response to active and/or resisted maneuvers in one or more regions: cervical spine, upper limbs, TMJ and eyes; * Tinnitus modulation by activation of muscle trigger points in the regions: skull, cervical spine and upper limbs; * Patients who did not present modulation, but were classified as having somatosensory tinnitus due to the following symptomatology: recurrent headaches, pain in the cervical or scapular region; temporal coincidence of the onset of tinnitus with musculoskeletal pain; dental manipulation and trauma in the head and neck region; tinnitus due to inadequate postures and/or bruxism for long periods; dysfunction and/or alterations of the cervical spine associated with tinnitus; Patients with and without hearing loss were included. Exclusion Criteria: * Patients who had undergone physiotherapy and/or manual therapy for pain and tinnitus treatment up to 3 months prior to the initial assessment; * Severe depression requiring medication; * Clinical diagnosis of fibromyalgia; * Neurological diseases; * Contraindications for physiotherapy treatment, such as fractures, tumors; * Acute rheumatological diseases.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Questionnaire Tinnitus Handicap Inventory (THI)

Timeframe: Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.

Trial details

NCT IDNCT07486011

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-07

View on ClinicalTrials.gov More Tinnitus trials