NCT03782220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

December 17, 2018

Last Update Submit

December 18, 2018

Conditions

Keywords

somatosensory tinnitusneck painkinesio taping

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Kinesio taping group

EXPERIMENTAL

Kinesio taping group * Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles. * Once a week , for 4 weeks

Other: Kinesio tape

Shame taping group

PLACEBO COMPARATOR

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

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.

Kinesio taping group

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.

Shame taping group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

TinnitusNeck Pain

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 20, 2018

Study Start

September 20, 2017

Primary Completion

April 18, 2018

Study Completion

September 7, 2018

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations