Osteopathic Treatment Versus Sham in the Discomfort and Magnitude of 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:
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:
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.
Inclusion criteria:
Exclusion Criteria: