Effects of Kinesio Taping in Patients With Somatosensory Tinnitus

Study Overview
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Brief Summary
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There is no specific treatment that can cure somatosensory tinnitus and usually conservative physical therapy modalities are used in the literature. The aim of the study is to investigate the effect of kinesio taping applied to sternocleidomastoid, upper trapezium and levator scapulae muscles on the somatosensory tinnitus associated with neck complaints.

Detailed Description
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The study was designed as a prospective, randomized controlled and double blind trial. Patients complaining of tinnitus were firstly subjected to otologic and audiologic evaluation by an otolaryngologist. Tinnitus characteristics, such as severity (Tinnitus handicap Index, tinnitus Visual Analog Scale- tinnitus VAS) , type (pulsatile/non-pulsatile), localization (unilateral/ bilateral) and the frequency (number of days with symptoms) were recorded. Patients were excluded if they had objective tinnitus, subjective tinnitus with hearing loss or Meniere's disease, vertigo, middle ear pathologies, intracranial pathologies, whiplash injury, previous cervical spinal surgery, pregnancy, infection, malignancy and if they received cervical physical rehabilitation program in the past 3 months. Patients who diagnosed with somatosensory tinnitus and concomitant neck complaints (cervical-VAS score >2) at least 6 weeks were referred to physical medicine and rehabilitation outpatient clinic. Before the treatment, participants' demographics data including age, gender, Body-Mass Index (BMI) and cervical pain VAS score were recorded and physical examinations (cervical joint range of motion (cervical-ROM), cervical manual muscle testing (cervical-MMT) and myofascial trigger points for sternocleidomastoid, upper trapezium and levator scapulae muscles) were performed by one investigator. Banding application performed for both groups once a week for four weeks. Tinnitus handicap index score, tinnitus VAS, ROM of the cervical joint, cervical MMT, cervical pain VAS, Neck Disability index score and myofascial trigger points of sternocleidomastoid, upper trapezium, levator scapula was evaluated in all subjects by the same investigator.

Official Title
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Effects of Kinesio Taping in Patients With Somatosensory Tinnitus: A Randomized Controlled Trial

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Other: Kinesio tape
* Other: Shame tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has somatosensory tinnitus Subject has concomitant neck complaints (cervical-VAS score >2) at least 6 weeks Subject were referred to physical medicine and rehabilitation outpatient clinic Exclusion Criteria: History of objective tinnitus History of subjective tinnitus with hearing loss History of Meniere's disease History of vertigo Hiistory of middle ear pathologies History of intracranial pathologies History of whiplash injury History of previous cervical spinal surgery History of infection or malignancy Pregnancy History of having received cervical physical rehabilitation program in the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesio taping group<br>Kinesio taping group Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles. Once a week , for 4 weeks | Other: Kinesio tape<br>* The Kinesio taping ( Kinesio Tex Gold, 2in x103.3 ft) was applied to sternocleidomastoid, upper trapezium and levator scapulae muscles by the muscle inhibition technique ( from insertion to origin of a muscle) for experimental group.<br>|
| Placebo Comparator: Shame taping group<br>Shame taping group Application of kinesio band to same muscles except for the defined method which is considered to be ineffective. Once a week , for 4 weeks | Other: Shame tape<br>* For the Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension and with the neck in neutral position was used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus handicap Index (THI) | The questionnaire comprises 25 items with a functional subscale (11 items), emotional subscale (9 items), and catastrophic subscale (5 items). Each question is rated as 0 (none), 2 (sometimes), or 4 (always). Total score range from 0 to 100, with higher scores indicating higher levels of perceived tinnitus handicap. | 4 weeks | 
| Tinnitus severity (tinnitus-VAS) | The loudness of tinnitus was graded with a10 cm of visual analog scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely loud tinnitus) | 4 weeks | 
| Cervical pain (cervical-VAS) | Pain intensity was measured with VAS which is used to measure musculoskeletal pain with very good reliability and validity (VAS, 0-10 cm; 0 means no pain, 10 means severe pain). | 4 weeks | 
| Neck Disability index score (NDI) | The NDI is designed to assess self - reported neck functional status. The questionnaire comprises 10 items related to pain, activities of daily living, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation, each rated on a 6-point Likert scale with a final score range of 0 (no disability) to 50 (major disability). Higher scores represent greater disability | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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somatosensory tinnitus, neck pain, kinesio taping