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临床试验/NCT03782220
NCT03782220已完成不适用

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

Hitit University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
Neck Disability index score (NDI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Kinesio taping group

Experimental

Kinesio taping group

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

干预措施: Kinesio tape (Other)

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

干预措施: Shame tape (Other)

结局指标

主要结局

Neck Disability index score (NDI)

时间窗: 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

Tinnitus handicap Index (THI)

时间窗: 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.

Cervical pain (cervical-VAS)

时间窗: 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).

Tinnitus severity (tinnitus-VAS)

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğba Atan

Assoc. Prof.

Hitit University

研究点 (2)

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