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CompletedNCT03782220Updated Dec 20, 2018

Effects of Kinesio Taping in Patients With Somatosensory Tinnitus

An interventional study of Kinesio tape and Shame tape in Tinnitus, Subjective, sponsored by Hitit University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-20.

Sponsored by Hitit University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2017, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Tinnitus, Subjective

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Keywords

  • somatosensory tinnitus
  • neck pain
  • kinesio taping
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In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 37 is below the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Hitit University is the lead sponsor of 79 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
37 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherKinesio 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.

  • OtherShame 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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)

    Time frame: 4 weeks

  3. 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).

    Time frame: 4 weeks

  4. 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

    Time frame: 4 weeks

07

Study locations

1 site
  • Tuğba Atan
    Çorum, 19100, Turkey
08

References and documents

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. PubMed 28099967 ↗
  • 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. PubMed 20505927 ↗
  • 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. PubMed 23306563 ↗
  • 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. PubMed 27592038 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03782220
Lead sponsor
Hitit University
Responsible party
Tuğba Atan (Assoc. Prof., Hitit University) — Principal investigator
First posted
Dec 20, 2018
Start date
Sep 20, 2017
Primary completion
Apr 18, 2018
Completion
Sep 7, 2018
Last update
Dec 20, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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