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NCT Number: NCT03782220

Effects of Kinesio Taping in Patients With Somatosensory Tinnitus

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.

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Key information

Conditions

Tinnitus, Subjective Ear Diseases Hearing Disorders Neck Pain Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesio Tape

Other

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.

Shame tape

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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