Neck Kinesiotherapy and Massage in Tinnitus Treatment

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the effectiveness of cervical spine kinesiotherapy and massage in tinnitus treatment. Furthermore, we investigate if there is a link between cervical spine range of motion and cervical muscles tension and tinnitus.

Detailed Description
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The study is planned with power of 80%. A total of 118 adult patients with subjective tinnitus are divided into two groups: Kinesiotherapy group (n=59) and Waiting list group (n=59).Kinesiotherapy group receives a complex set of cervical spine exercises and neck massage for consecutive 10 working days (entire treatment takes two weeks). Each visit lasts around 30 minutes. Patients from kinesiotherapy group will fill the outcome measures on the following time points: (a) Time point 0 - baseline (b) Time point 1- Two weeks after the baseline (c) Time point 2- Four weeks after the baseline. Individuals from waiting list group are enrolled on a waiting list and do not receive any treatment. They undergo assessment at three time points corresponding to Kinesiotherapy group i.e Time point 0, Time point 1 and Time point 2. .

Official Title
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Physiotherapy Methods in Tinnitus Treatment

Conditions
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Subjective Tinnitus

Intervention / Treatment
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* Other: Complex set of kinesiotherapy of cervical spine and delicate massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Adult patients with subjective tinnitus experienced in the ears or in the head (temporary and constant tinnitus) with and without sensorineural hearing loss. Exclusion Criteria: Other tinnitus treatment in last 6 months, Objective tinnitus, External and middle ear pathology, Acute infections, conditions with fever Bleedings or risk of bleeding Severe respiratory and circulatory insufficiency vasculitis, thrombophlebitis, Pregnancy Acute arthritis and periarticular soft tissues inflammation in the cervical region, Severe pains in different locations, Advanced osteoporosis Uniformed services. Cervical spine instability, cervical disc herniation, cervical radiculopathy. Status post cervical spine surgery. Status post lumbar puncture, status post computed tomography with contrast. Lack of cooperation between the patient and the therapist, cognitive impairment. Atherosclerosis, vertebrobasilar insufficiency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a non randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesiotherapy group<br>This is the group (n=59) receives treatment i.e complex set of neck exercises and massage | Other: Complex set of kinesiotherapy of cervical spine and delicate massage<br>* Intervention:- A complex neck therapy.Treatment comprises 10 sessions performed on consecutive working days, includes four parts. Active exercises of the neck, 5 minutes, first demonstrated by the physiotherapist and next the patient performs them under supervision, 5 repetitions of each of the following: cervical flexion, rotation to the left and to the right, side bending to the left and to the right, torsion to left and right. Massage of cervical interspinales muscles performed by therapist 3 minutes. Post Isometric Relaxation (PIR) performed by physiotherapist. 15 minutes. Active neck exercises - the same as mentioned in step 1. 5 minutes. Total duration of one treatment session is around 30 minutes.<br>|
| No Intervention: Waiting List group<br>Individuals registered in the waiting list for receiving the treatment specified for kinesiotherapy group (n=59).These patients receive no treatment for tinnitus. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index (TFI), a Polish validated version (Wrzosek et al., 2016). | The Tinnitus Functional Index is a comprehensive scale, assessing tinnitus severity, comprising 25 questions. It has eight subscales: intrusiveness, sense of control, cognitive, sleep, auditory, relaxation, quality of life, and emotion. Patients can mark their response on a scale starting from zero (0) to maximum response (10). Maximum possible score of TFI is 250 if the respondent were to mark all 25 TFI items at the maximum value of 10. High scores on TFI scale are interpreted as increased severity of tinnitus and negative impact on patients life. Total TFI score is analyzed at three time points as described above. Statistical analysis is performed using repeated measures ANOVA to evaluate if there is a significant difference in the mean TFI score at the three time points. | Time point 0: Baseline, Time point 1: 2 weeks after baseline, Time point 2: 4 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory (THI), Polish validated version | 2. Tinnitus Handicap Inventory (THI), Polish validated version Tinnitus Handicap Inventory measures the impact of tinnitus on the daily life of the patients. The questionnaire is subdivided into categories functional (11 questions), emotional (9 questions) and catastrophic (5 questions) :Tinnitus Handicap Inventory comprises 25 questions with three options for answer: Yes, NO, Sometimes. The scoring for these options is Yes= 4,NO =0 ,sometimes=2. The possible score for Tinnitus Handicap Inventory can range from 0 to 100. Higher scores are interpreted as greater handicap due to tinnitus.Total THI score will be analyzed at three time points as for TFI. | as for TFI | 
| Visual Analogue Scale (VAS) | The Visual Analogue Scale (was used to asses subjective tinnitus loudness). The patient will report averaged loudness of their tinnitus in the past week on a 10 centimeter line. The left end of the line was marked with 0 indicating no tinnitus, while the right end was marked with 10, indicating maximum loudness of tinnitus. Visual Analogue scale score will be assessed on three time points - as for TFI. Visual Analogue scale score will be assessed on three time points - as for TFI. | as for TFI | 
| Range of motion of cervical spine | This is the range of neck movements that the patient can actively perform, measured from the neutral to maximum position (cervical flexion, cervical rotation to left and to right, cervical side bending to left and right. The SFTR method where S represents - sagittal (sagittal plane); - Page 3 of 6 [DRAFT] - F - Frontal plane; T - transverse (transverse plane); R - rotation (rotational movements) will be used for assessment and recording cervical spine range of movement (Gerhardt,1983). The normal range of movement of cervical spine according to SFTR method in centimetres, is as follows: Cervical Spine flexion 18-40 years adults- 3 cm. 41-60 years adults- 2.5 cm. 61-85 years adults- 2 cm Cervical Side bending 18-40 years adults- 6.5 cm. 41-60 years adults- 5 cm. 61-85 years adults- 4 cm Cervical rotation 18-40 years adults- 8 cm. 41-60 years adults- 7.5 cm. 61-85 years adults- 6 cm. | as for TFI | 
| Cervical muscle tension (MST) | The cervical muscle tension will be assessed by palpation. Palpation is widely used as a physiotherapy assessment tool in patient examination (MAITLAND, 1982). Muscle tension will be graded using the dichotomous scale of 0 and 1 where 0 will be interpreted as normal and 1 will be interpreted as presence of pathological muscle tension. | same as for TFI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjective tinnitus,, massage, Post Isometric Relaxation Exercises, Kinesiotherapy