Effects of Osteopathic Treatment in Patients With Somatosensory Tinnitus

NCT07486011 | Completed

• 2 other identifiers: 61346772.3.0000.00683jxtfm8
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Keywords

tinnitus; somatosensory tinnitus; osteopathic manipulative treatment; manual therapy

Outcome Measures

Primary Outcomes (1)

• Questionnaire Tinnitus Handicap Inventory (THI)

  The THI is a questionnaire used to measure the degree of annoyance caused by tinnitus. The questionnaire consists of 25 questions divided into three scales: functional, emotional, and catastrophic. There are three possible answers for each question, scored as follows: yes (4 points), sometimes (2 points), and no (no points). Answers are scored from zero, when tinnitus does not interfere with the patient's life, to 100 (points or %), when the degree of annoyance is severe. The sum of the points resulting from the questions is categorized into five groups or degrees of severity. Tinnitus can be: negligible (0-16%), mild (18-36%), moderate (38-56%), severe (58-76%), or catastrophic (78-100%).

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

Secondary Outcomes (8)

• Tinnitus Assessment: Pich

  Time period: Start of treatment, after 8 weeks (end of treatment).

• Tinnitus Assessment: loudness

  Evaluation period: Beginning of treatment, after 8 weeks (end of treatment).

• Tinnitus Assessment: Masking

  Evaluation period: Beginning of treatment, after 8 weeks (end of treatment).

• Visual Analogue Scale (VAS)

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

• Questionnaire Neck Disability Index (NDI)

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

Study Arms (2)

Sham treatment is a placebo treatment that simulates osteopathic treatment.

PLACEBO COMPARATOR

The sham treatment consisted of applying a placebo that simulated osteopathic treatment. Manual touches were applied to areas of the head, neck, chest, and abdomen for 30 minutes per session. Eight placebo sessions were conducted with a one-week interval between them. The total treatment period was 2 months, and after treatment completion, patients returned at 3 and 6 months for evaluations. Assessment measurements were collected before, after treatments, and at the 3- and 6-month follow-ups.

Other: Placebo treatment

osteopathic treatment

ACTIVE COMPARATOR

The researchers employed individually selected manual techniques, based on the type of tissue and region to be treated according to a prior osteopathic assessment. Eight thirty-minute sessions were conducted, with a one-week interval between them. The total treatment period was two months, and after treatment, patients returned at three and six months for evaluations. Evaluative measurements were taken before, after treatment, and at the three- and six-month follow-up appointments.

Other: osteopathic treatment

Interventions

osteopathic treatment OTHER

Researchers employ individually selected manual techniques, according to the type of tissue and region to be treated, based on a prior assessment. Functional techniques for: muscles, viscera, membranes, and cranial sutures, bringing the insertions of these tissues closer together to reduce tension. Connective tissue techniques, with sustained and rhythmic stretching, muscle energy, and neuromuscular techniques, working primarily on the fascia and muscles. Impulse techniques (high speed and low amplitude) are used to trigger afferent reflexes, up to the spinal cord or brainstem, depending on the structure being worked on, to improve pain and range of motion in the joints of the cervical and thoracic spine, as well as in the TMJ and ribs. Articular techniques in the cranial sutures, TMJ, and cervical spine, aiming to use rhythmic movements to treat dysfunctions in the articular tissues of the cervical spine, ribs, TMJ, and cranial sutures.

osteopathic treatment

Placebo treatment OTHER

Sham treatment is a placebo simulating osteopathic treatment. Prior patient assessments were conducted to identify somatic dysfunctions. Unlike osteopathic treatment, where the patient was treated directly, sham treatment used manual touches on predetermined areas of the patient's body. The areas where patients presented the main somatic dysfunctions were: head, neck, temporomandibular joint, thorax, and abdomen. The treatment consisted of touches on these areas through a predetermined sequence, lasting a total of thirty minutes.

Sham treatment is a placebo treatment that simulates osteopathic treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05.403-905, Brazil

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor specializing in Otolaryngology and Otoneurology, PhD in Otolaryngology from USP.

Model Details: Patients were randomized into two different groups. Group A received Osteopathic Treatment (OT), associated with a series of home exercises and educational guidance on tinnitus. Group B received Sham Treatment (ST), also associated with a series of home exercises and educational guidance on tinnitus. In both groups (A and B), a general and specific osteopathic assessment was performed by the Osteopathic Physiotherapist. The treatments consisted of eight sessions, with a frequency of one session per week. Each session lasted thirty minutes in both groups. Before the start of treatment, an osteopathic assessment lasting thirty minutes was performed, and on the same day, the first session was initiated, also lasting thirty minutes. Both patients were followed up at 3 and 6 months without intervention.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 20, 2026
• Study Start: September 2, 2022
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: March 2026 to March 2023
• Access Criteria: Access criteria for sharing individual patient data will be through direct contact with researcher Alexandre de Mattos Rabello via email: alexandremrabello@yahoo.com.br.

Locations

BR (1)