Effects of Osteopathic Treatment in Patients With Somatosensory Tinnitus

Osteopathic Treatment Versus Sham in the Discomfort and Magnitude of Patients With Somatosensory Tinnitus

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Other: Placebo treatment; Other: osteopathic treatment

Detailed Description

Study Protocol The study is a randomized, single-blind, controlled clinical trial.

Sample The sample consisted of 54 patients treated at the Tinnitus Research Group of Hospital Clínicas Faculty of Medicine University of São Paulo (HCFMUSP) in Otoneurology Sector of the Department of Otorhinolaryngology (OSDO), with somatosensory subtype tinnitus.

The sample size calculation was performed using Gpower 3.1.9.2 software (University Dusseldorf, Germany), based on data from 12 patients collected through a pilot study with a start date of 10/19/2020 and an end date of data collection of 10/01/2021, whose compiled outcome was the Tinnitus Handicap Inventory Questionnaire (THI), to find an average difference of 20% in the score, with an alpha of 0.05 and a power of 80%, the calculated sample was equal to 27 patients per group.

Inclusion criteria: patients with unilateral or bilateral tinnitus for at least 6 months; both sexes; Patients aged 18 and over who exhibit modulation, that is, perceive changes in the psychoacoustic characteristics of tinnitus (intensity, frequency, and/or location) in response to active and/or resisted maneuvers in one or more regions: cervical spine, upper limbs, temporomandibular joint (TMJ), and eyes. As well as tinnitus modulation by activation of muscle trigger points in the regions of: skull, cervical spine, and upper limbs.

Patients who did not exhibit modulation but were classified as somatosensory tinnitus due to the following symptomatology were included: recurrent headaches, neck pain, or shoulder girdle pain; temporal coincidence in the onset of tinnitus with musculoskeletal pain; teeth grinding and trauma to the head and neck region; tinnitus resulting from 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.

Patients who had undergone physiotherapy and/or manual therapy for pain and tinnitus treatment up to 3 months prior to the initial assessment were excluded from the study. Patients with severe depression using medication, a clinical diagnosis of fibromyalgia, neurological diseases, and contraindications for physiotherapy treatment such as fractures, tumors, and acute rheumatological diseases were also excluded.

General Procedures All patients underwent otolaryngological and speech-language pathology evaluation, including anamnesis and physical examination, tonal and vocal audiometry, tympanometry, and tinnitus assessment. Laboratory and imaging tests were requested and performed when deemed necessary, according to the medical team's assessment.

After the completion of all examinations, the patients were referred by the medical team to the group of Physiotherapists specializing in Osteopathy. At this time, the study was explained in detail to the participants, and the Informed Consent Form (ICF) was presented for reading and signing. Next, the patients' personal and demographic data (sex, age, weight, height) were collected.

After inclusion in the study, patients were randomized into blocks using the website (http://www.randomization.com), where information such as sample size and number of groups was entered.

Patients who had complete examinations were randomized into two different groups. Group A receives Osteopathic Treatment (OT), associated with a series of home exercises and educational guidance on tinnitus. Group B receives 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.

Five researchers participated in the study: Researcher 1 (R1), Researcher 2 (R2), Researcher 3 (R3), Researcher 4 (R4), and Researcher 5 (R5). The roles and blinding were distributed as follows:

R1, an Otolaryngologist at OSDO of HCFMUSP, was responsible for delivering the questionnaires to the participants, clarifying any doubts during completion, as well as scoring the instruments THI, Neck Desability Index (NDI), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Insomnia severity index (ISI). She also performed assessments using the Visual Analog Scale (VAS), somatic modulation tests, and myofascial trigger point tests, and recorded the data in a table. The researcher remained blinded to the allocation of participants to the randomization groups.

R2, a speech therapist at OSDO of HCFMUSP, was responsible for performing the tonal and vocal audiometry, tympanometry, and tinnitus assessments, remaining blinded to the randomization of participants.

Researchers R3, R4, and R5 are Osteopathic Physiotherapists, trained at the Escuela de Osteopatia de Madrid, with a specialist title granted by the Federal Council of Physiotherapy and Occupational Therapy (FCPOT) with approximately 10 years of clinical practice. Working as collaborators of OSDO at HCFMUSP, they were responsible for randomization, blinding of patients, performing osteopathic assessment (General and Specific), and treatment of patients. These researchers were not blinded regarding group allocation, since they needed to perform the interventions corresponding to the OT or ST groups.

R1 used the following evaluative measures: THI and VAS as a tool for measuring discomfort in tinnitus. For the assessment of disability and cervical pain, the NDI questionnaire was used. Screening for symptoms of anxiety and depression was assessed respectively by the GAD-7 and PHQ-9 questionnaires. And insomnia was assessed by the IGI questionnaire. Somatic modulation maneuvers were performed by R1 and organized into mandibular, head and neck, shoulder, and eye groups. Mandibular somatic modulation maneuvers included active movements (performed by the patient) and movements against resistance (applied by R1) comprising: mouth opening and closing, mandibular protrusion, and mandibular dilation to the right and left. Head and neck somatic modulation maneuvers included active movements (performed by the patient) and movements against resistance (applied by R1): flexion and extension, right and left rotation, left and right lateral flexion. Shoulder elevation somatic modulation maneuvers against resistance and eye movements.

The muscles evaluated in the somatic tests were: upper trapezius fibers, splenius capitis/suboccipital muscles, scalenes, sternocleidomastoids, infraspinatus, levator scapulae, masseter muscles, anterior, medial and posterior temporal fibers, and posterior digastric muscles.

R2 underwent an audiological evaluation, consisting of pure-tone audiometry from 250Hz to 8kHz and speech audiometry, high-frequency audiometry from 9kHz to 16kHz, auditory discomfort threshold from 500Hz to 4kHz, tympanometry, and tinnitus measurement.

Tinnitus assessment investigated the frequency (pitch), intensity (loudness) of tinnitus, as well as the minimum masking loudness and residual inhibition, comprising the so-called Psychoacoustic Measures of Tinnitus (PMT). Its main objectives were: to determine the psychoacoustic characteristics of tinnitus perception and to measure the magnitude, allowing the evaluation of clinical evolution to treatment. For this reason, in this research, PMT was used in the initial audiological evaluation and at the end of the OT and ST.

Subsequently, researchers R3, R4, and R5, using their service scales, performed a general and specific (Osteopathic) evaluation. These researchers did not have access to the information collected by R1 and R2, including questionnaires, VAS, somatic modulation maneuvers, myofascial trigger point assessment, and audiological tests. They only had access to information regarding the allocation group of participants: Group A or Group B.

After inclusion in the study, patients signed the informed consent form. Subsequently, questionnaires, VAS, somatic tests, and myofascial trigger point assessments were applied. Then, participants were randomly assigned.

Patients allocated to Group A, after evaluation by researchers R3, R4, or R5, received occupational therapy intervention using selected techniques. The selection of techniques was carried out individually, at the researcher's discretion, according to the clinical needs of each patient in each session. Eight sessions were conducted, once a week. Patients in Group A also received guidance on performing a series of home exercises, as well as educational guidance on tinnitus. At each osteopathy session, patients were again instructed on how to perform the exercises and any questions were clarified.

Researchers R3, R4, or R5 performed ST on patients allocated to Group B after an initial assessment, which consisted of applying touches to body regions simulating the OT. Similar to Group A, these patients received instructions to perform the same series of home exercises, as well as educational guidance on tinnitus. In all sessions, instructions regarding the execution of the exercises were reinforced and questions about the tinnitus symptom were clarified.

The researchers conducted assessments using questionnaires, modulation tests: somatic and myofascial trigger points, in addition to examinations in Groups A and B.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05.403-905
      • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham treatment is a placebo treatment that simulates osteopathic treatment.; 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; 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.
Active Comparator: osteopathic treatment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Assessment: Pich	Tinnitus assessment, an examination performed by speech-language pathologists, aims primarily to determine the characteristics related to tinnitus perception. The examination investigates the frequency of the sound sensation (pitch) - high, medium, or low, measured in kilohretz (kHz).	Time period: Start of treatment, after 8 weeks (end of treatment).
Tinnitus Assessment: loudness	Acufenometry aims to determine the characteristics related to tinnitus perception, specifically the intensity (volume) of the tinnitus, measured in decibels (dB).	Evaluation period: Beginning of treatment, after 8 weeks (end of treatment).
Tinnitus Assessment: Masking	Acufenometry aims to determine the characteristics related to the magnitude of the tinnitus, as well as the minimum masking volume (MMV) and residual inhibition.	Evaluation period: Beginning of treatment, after 8 weeks (end of treatment).
Visual Analogue Scale (VAS)	The VAS (Visual Analogue Scale) is a metric scale for measuring the intensity or frequency of psychometric symptoms. It can be presented to the patient in various ways; however, the most common is a horizontal ruler with a fixed length of 100 mm or 10 cm. The patient chooses the point on the VAS that best represents their perception of the current state (in the last 24 hours) of their symptom. The scale ranges from 0 cm, which represents "absence of symptom," to 10 cm (worst imaginable symptom). The intensity of the symptom can be interpreted as follows: mild (up to 2 cm), moderate (3 to 7 cm), severe (8 to 10 cm). The scale needs to be shown to the patient so that they can see it, rather than hear it (it is visual and not auditory).	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)	The NDI is used to assess the functional capacity of the cervical region. It consists of 10 questions related to general activities and pain. Items are organized by activity type and followed by six different statements expressing progressive levels of functional capacity. Each item is composed of a scale ranging from 0 to 5, totaling a maximum of 50 points, with 0 corresponding to no disability and 5 to extreme disability. The total score ranges from 0 to 50, with scores between: 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25-34 = severe disability, and above 34 = complete disability. The total score results from the sum of the scores of all items and can be converted to a scale of 0 to 100 by multiplying by 2. It is only calculated when patients answer at least 8 items. If patients do not answer 3 items, the questionnaire should be considered invalid.	Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.
Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a questionnaire that allows for the assessment of depressive symptoms and their severity. It has nine questions that refer to the patient's perception of their emotional state over the past fourteen days. Each question presents answers on a graduated scale ranging from 0 to 3, with 0 being (never), 1 (on several days), 2 (on more than half the number of days), and 3 (on almost every day). The total score is calculated by adding the ratings of the nine symptom items (0-27). The severity ranges in this score are: absence of depressive symptoms 0 to 4; mild depressive symptoms 5 to 9; moderate depressive symptoms 10 to 14; moderately severe depressive symptoms 15 to 19; and severe depressive symptoms 20 to 27.	Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.
Generalized Anxiety Disorder Questionnaire 7 (GAD-7)	The GAD-7 questionnaire is used to assess the presence of anxiety symptoms. It has seven assessment questions that refer to the patient's perception of their emotional state over the past fourteen days. Each question has responses graded on a four-point scale from 0 to 3, where 0 (never), 1 (several days), 2 (more than half the days), and 3 (almost every day). The total score is calculated by adding the total scores of the seven questions from 0 to 21. The severity ranges in this score are: 0 to 7 no anxiety, score above 8 points probable anxiety disorder.	Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.
Insomnia Severity Index (ISI)	The questionnaire is used to assess the severity of insomnia. It has 5 questions, the first of which is divided into letters A, B, and C. The questions are graded on a five-point scale from 0 to 4, where 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe). The total score is calculated by adding up the total scores of the questions. The severity ranges are: 0 to 7 did not meet the criteria for insomnia, 8 to 14 lower limit for insomnia, 15 to 21 moderate clinical insomnia, and 22 to 28 severe clinical insomnia.	Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): November 7, 2025
• Study Completion (Actual): November 7, 2025

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: manual therapy; tinnitus; osteopathic manipulative treatment; somatosensory tinnitus
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations; Manipulation, Osteopathic
• Other Study ID Numbers: 61346772.3.0000.0068; 3jxtfm8 (Other Identifier: Brazilian Registry of Clinical Trials (ReBEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access criteria for sharing individual patient data will be through direct contact with researcher Alexandre de Mattos Rabello via email: alexandremrabello@yahoo.com.br.
• IPD Sharing Time Frame: March 2026 to March 2023
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No