Osteopathic Treatment Versus Sham in the Discomfort and Magnitude of Patients With Somatosensory Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Questionnaire Tinnitus Handicap Inventory (THI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Questionnaire Tinnitus Handicap Inventory (THI)
时间窗: Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.
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%).
次要结局
- 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.)
- Patient Health Questionnaire (PHQ-9)(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)(Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.)
- Insomnia Severity Index (ISI)(Time period: Start of treatment, after 8 weeks (end of treatment), 3-month follow-up, and 6-month follow-up.)
研究者
Jeanne Oiticica
Medical Doctor specializing in Otolaryngology and Otoneurology, PhD in Otolaryngology from USP.
University of Sao Paulo General Hospital