Effects of Kinesio Taping in Patients With Somatosensory Tinnitus
1 other identifier
interventional
37
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2018
CompletedFirst Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedDecember 20, 2018
December 1, 2018
7 months
December 17, 2018
December 18, 2018
Conditions
Keywords
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
EXPERIMENTALKinesio taping group * Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles. * Once a week , for 4 weeks
Shame taping group
PLACEBO COMPARATORShame 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
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.
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.
Eligibility Criteria
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
- Hitit Universitylead
Study Sites (1)
Tuğba Atan
Çorum, 19100, Turkey (Türkiye)
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.
PMID: 28099967RESULTVanneste 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.
PMID: 20505927RESULTRocha 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.
PMID: 23306563RESULTMichiels 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.
PMID: 27592038RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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