跳至主要内容
临床试验/NCT07021586
NCT07021586招募中不适用

Tongue Pressure in Middle-Aged and Elderly Individuals With Chronic Cervical Pain

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Maximal tongue pressure

研究概览

简要总结

The goal of the cross-sectional study is to explore the impact of neck pain on tongue pressure in the middle-aged and elderly population and analyze the effects of different cranio-cervical positioning on tongue pressure performance.

The main questions it aims to answer are:

  1. Do middle-aged and elderly individuals with chronic cervical pain exhibit reduced maximal tongue pressure compared to those without cervical pain?
  2. What are the effects of different cranio-cervical positioning on tongue pressure performance?

Participants will complete all the assessments on the day of testing.

详细描述

  1. For Quality assurance plan that addresses data validation and registry procedures:

(1) Relevant data will be recorded by the researchers. All assessments will be conducted in the Orthopedic Laboratory at National Yang Ming Chiao Tung University, where the equipment is regularly maintained and monitored.

  1. For Standard operating procedures to address registry operations and analysis activities:

(1 ) Participants will be recruited from clinics and communities in the Taipei and New Taipei City. Collected data will include personal information such as height, age, weight, and the number of removable dentures. Data management and analysis will be conducted using laboratory-designated computers for data storage and processing. Any adverse events, such as throat or tongue soreness occurring within 1-2 days after testing, will be recorded and reported to the researchers.

  1. For Sample size assessment:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • 未提供

排除标准

  • Neurological diseases that may affect tongue pressure readings, such as stroke or Parkinson's disease
  • Head or neck surgery in the past year
  • Severe head or neck injuries (e.g., whiplash from a car accident) in the past year
  • Diagnosed with cervical radiculopathy or myelopathy with symptoms in the form of numbness or tingling, or fail relative clinical tests (spurling's/ cervical distraction/ cervical rotation test/ upper limb tension test-1/ Hoffman sign)
  • History of head or neck deformities or cancer
  • History of head or neck radiation therapy
  • Diagnosed with dysphagia
  • Experience pain or restricted movement in the temporomandibular joint (TMJ) during chewing in the last 6 months
  • Require anticonvulsants or antidepressant medications
  • Cognitive impairments preventing understanding of the test order or communication

结局指标

主要结局

Maximal tongue pressure

时间窗: Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.

Tongue pressure is used to measure the function or strength of the tongue. The higher the value, the greater the tongue strength. The measurement unit is kPa, with 0 being the minimum value. It tends to decrease with age, typically with 60 years old as the cutoff. For those under 60, the value is around 40 kPa, and for those over 60kPa, it decreases to around 33 kPa. Additionally, when accompanied by other conditions, such as dysphagia or sarcopenia, the decline is more pronounced.

次要结局

  • Mandarin version of Eating Assessment Tool-10(It usually take 5-10 minutes to finish the questionnaire)
  • Repetitive Saliva Swallowing Test(It usually take 30 seconds to collect the data.)
  • Temporomandibular joint kinematics(Because it is a cross sectional study with one-time measurement, it usually take twenty minutes to collect the data.)
  • Craniovertebral angle(Because it is a cross sectional study with one-time measurement, it usually take five minutes to collect the data.)
  • Maximal handgrip strength(It usually take five minutes to collect the data.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Fen Shih

Professor, Department of Physical Therapy and Assistive Technology, National Yang Ming Chaio Tung University

National Yang Ming Chiao Tung University

研究点 (1)

Loading locations...

相似试验