Effects of Kinesio Taping in Patients With Somatosensory Tinnitus
Primary Purpose
Tinnitus, Subjective
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape
Shame tape
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective focused on measuring somatosensory tinnitus, neck pain, kinesio taping
Eligibility 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
Sites / Locations
- Tuğba Atan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Kinesio taping group
Shame taping group
Arm Description
Kinesio taping group Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles. Once a week , for 4 weeks
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
Outcomes
Primary Outcome Measures
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.
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)
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).
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03782220
Brief Title
Effects of Kinesio Taping in Patients With Somatosensory Tinnitus
Official Title
Effects of Kinesio Taping in Patients With Somatosensory Tinnitus: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
September 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
Keywords
somatosensory tinnitus, neck pain, kinesio taping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinesio taping group
Arm Type
Experimental
Arm Description
Kinesio taping group
Application of kinesio taping to sternocleidomastoid, upper trapezium, levator scapulae muscles.
Once a week , for 4 weeks
Arm Title
Shame taping group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Kinesio tape
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Shame tape
Intervention Description
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 Measure Information:
Title
Tinnitus handicap Index (THI)
Description
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
Title
Tinnitus severity (tinnitus-VAS)
Description
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
Title
Cervical pain (cervical-VAS)
Description
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
Title
Neck Disability index score (NDI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tuğba Atan
City
Çorum
ZIP/Postal Code
19100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
28099967
Citation
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.
Results Reference
result
PubMed Identifier
20505927
Citation
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.
Results Reference
result
PubMed Identifier
23306563
Citation
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.
Results Reference
result
PubMed Identifier
27592038
Citation
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.
Results Reference
result
Learn more about this trial
Effects of Kinesio Taping in Patients With Somatosensory Tinnitus
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