Effects of Kinesio Taping in Patients With Somatosensory Tinnitus

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

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Other: Kinesio tape; Other: Shame tape

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çorum, Turkey, 19100
    • Tuğba Atan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio taping group; Kinesio taping group; Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles.; Once a week , for 4 weeks	Other: Kinesio tape; 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.
Placebo Comparator: Shame taping group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hitit University

Publications and helpful links

General Publications

• Ralli M, Altissimi G, Turchetta R, Mazzei F, Salviati M, Cianfrone F, Orlando MP, Testugini V, Cianfrone G. Somatosensory Tinnitus: Correlation between Cranio-Cervico-Mandibular Disorder History and Somatic Modulation. Audiol Neurootol. 2016;21(6):372-382. doi: 10.1159/000452472. Epub 2017 Jan 19.
• Vanneste S, Plazier M, Van de Heyning P, De Ridder D. Transcutaneous electrical nerve stimulation (TENS) of upper cervical nerve (C2) for the treatment of somatic tinnitus. Exp Brain Res. 2010 Jul;204(2):283-7. doi: 10.1007/s00221-010-2304-5. Epub 2010 May 28.
• Rocha CB, Sanchez TG. Efficacy of myofascial trigger point deactivation for tinnitus control. Braz J Otorhinolaryngol. 2012 Dec;78(6):21-6. doi: 10.5935/1808-8694.20120028.
• Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016 Dec;26:125-131. doi: 10.1016/j.math.2016.08.005. Epub 2016 Aug 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): April 18, 2018
• Study Completion (Actual): September 7, 2018

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: neck pain; kinesio taping; somatosensory tinnitus
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 2018-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No