Sensation Disorders
Conditions
Interventions
The study will be a randomized, single-blind, controlled clinical trial. A sample of 54 patients, regularly seen at the Tinnitus Research Group at the Hospital das Clínicas Faculdade de Medicina Unive
E02.190.599.280
Sponsors
Hospital das Clínica da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínica da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must present uni or bilateral tinnitus for at least 6 months; both sexes; age group above 18 years; that present modulation, that is, perceive alteration in the psychoacoustic characteristics of tinnitus (intensity, frequency and/or location) to active and/or resisted maneuvers in one or more regions: cervical spine, upper limbs, temporal mandibular joint (TMJ) and eyes; as well as modulation of tinnitus by activating muscle trigger points.Other influencing factors are: recurrent headaches, neck or shoulder girdle pain; temporal coincidence in the onset or increase of tinnitus with musculoskeletal pain; handling teeth and head and neck trauma; tinnitus increase due to inadequate postures and/or bruxism for long periods; dysfunction and/or changes in the cervical spine associated with the symptom; patients with and without hearing loss will be included
Exclusion criteria
Exclusion criteria: Patients who underwent physiotherapeutic treatment and/or manual therapies to treat pain and tinnitus up to 3 months before the initial assessment; severe depression in use of medication; clinical diagnosis of fibromyalgia; neurological diseases; and contraindications for physiotherapeutic treatment such as fractures, tumors and rheumatological diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in the tinnitus symptom, through the use of the tinnitus discomfort measurement questionnaire, Tinnitus Handicap Inventory (THI). The THI is a questionnaire used to assess the degree of tinnitus discomfort, quantifying the functional and psycho-emotional problems caused by tinnitus. The questionnaire is easy to apply and understand, consisting of 25 questions divided into three scales: functional, emotional and catastrophic. The functional scale (F) measures the discomfort caused by tinnitus in mental, social, occupational and physical functions with 11 questions. The emotional scale (E) measures affective responses such as anxiety, anger and depression, there are 9 questions for this scale. The catastrophic scale (C) quantifies the despair and inability reported by the affected person to live with or get rid of the symptom, with 5 questions selected for this item. There are three response options for each question, scored as follows: yes (4 points), sometimes (2 points) and no (no points). Responses are scored from zero, when tinnitus does not interfere with the patient's life, to 100 (points or %), when the degree of discomfort 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%). An improvement is expected and we will be able to observe in patients who undergo pragmatic osteopathic treatment an improvement of 11-20 points, compared to patients in the sham group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate tinnitus discomfort using the visual analogue scale (VAS). It is a metric scale for intensity or frequency of psychometric symptoms. It can be presented to the patient in different ways; however, the most common is a horizontal line ruler with a fixed length of 100mm or 10cm. The patient himself chooses on the VAS the point that best represents the perception of the current state (in the last 24 hours) of his symptom. A line with endpoints marked with two faces drawn: a smiley face indicating no annoyance/no perception of tinnitus (painted under the left endpoint of a line) and a sad one indicating extreme annoyance or extremely loud tinnitus (painted under the left endpoint of a line) right of a line). The scale varies from 0 cm, which represents “no symptom”, to 10 cm (worst imaginable symptom). The intensity of the symptom can be interpreted as follows: mild (up to 2 cm), moderate (from 3 to 7 cm), severe (from 8 to 10 cm). The scale needs to be shown to the patient so that he can see it rather than hear it (it is visual not auditory). An improvement of 1.5cm is expected in the pragmatic osteopathic treatment group, when compared to the sham group;Using the Neck Disability Index (NDI-BR) questionnaire, assess limitations related to neck pain in activities of daily living (ADL). The NDI is used to assess the functional capacity of the cervical region. Composed of 10 questions referring to general activities and pain. With items organized by type of activity and followed by six different statements expressing progressive levels of functional capacity. The average application time is three minutes. Each of the items 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, with the patient selecting the option that best suits and describes their situation. The total score varies between 0 and 50, considering that, for scores between: 0-4 = no disability, 5-14 = mild disabi | — |
Countries
Brazil
Contacts
Public ContactAlexandre Rabello
Alexandre de Mattos Rabello
Outcome results
None listed