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Effects of Kinesio Taping in Patients With Somatosensory Tinnitus

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ClinicalTrials.gov Identifier: NCT03782220
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Tuğba Atan, Hitit University

Brief 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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Other: Kinesio tape Other: Shame tape Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Kinesio Taping in Patients With Somatosensory Tinnitus: A Randomized Controlled Trial
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : September 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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.




Primary Outcome Measures :
  1. Tinnitus handicap Index (THI) [ Time Frame: 4 weeks ]
    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.

  2. Tinnitus severity (tinnitus-VAS) [ Time Frame: 4 weeks ]
    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)

  3. Cervical pain (cervical-VAS) [ Time Frame: 4 weeks ]
    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. Neck Disability index score (NDI) [ Time Frame: 4 weeks ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782220


Locations
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Turkey
Tuğba Atan
Çorum, Turkey, 19100
Sponsors and Collaborators
Hitit University

Publications of Results:
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Responsible Party: Tuğba Atan, Assoc. Prof., Hitit University
ClinicalTrials.gov Identifier: NCT03782220     History of Changes
Other Study ID Numbers: 2018-12
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tuğba Atan, Hitit University:
somatosensory tinnitus
neck pain
kinesio taping

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms