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临床试验/NCT05529641
NCT05529641已完成不适用

Effects of Combined Diaphragmatic Resistance Training and Cervical Stabilization Exercise in People With Chronic Neck Pain.

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2022年12月9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
入组人数
71
试验地点
1
主要终点
Pain intensity using Visual Analog Scale (VAS)

研究概览

简要总结

With increasing usage of electronic devices and sedentary lifestyle, chronic neck pain has become a more prevalent musculoskeletal disorder around the world. Many impairments have been identified in people with chronic neck pain including pain, muscle weakness, proprioceptive deficits and altered breathing pattern. Diaphragm is the key muscle for inspiration and also plays an important role in spinal stability. Previous studies have found that diaphragm functions are related to the stability of the lumbar spine through the fascial, neural and visceral systems. Diaphragmatic resistance training thus could have some positive effects on reducing pain and disability in people with low back pain. However, to date how diaphragmatic resistance training would affect chronic neck pain is still unknown. Therefore, the purpose of this study is to investigate the effects of diaphragmatic resistance training on pain, disability and movement quality in people with chronic neck pain.

详细描述

Chronic neck pain has become a more prevalent musculoskeletal disorder in modern society. The prevalence of chronic neck pain in 2021 gradually increases to 45.7%, that results in a large burden of health care. Chronic neck pain leads to neck motion limitation, motor control impairment and unsmooth motion. In addition, faulty breathing pattern has been identified in 83% of people with chronic neck pain. Diaphragm is the most critical muscle for inspiration and also plays an important role in spinal stability that might relate to spinal instability and pain. Studies have proved that effects of diaphragmatic resistance training on reduce pain and improving quality of life in people with low back pain. Diaphragm connects to the lumbar spine and also to the cervical spine through the fascial, neural and visceral system. However, to our best knowledge, the effects of diaphragmatic resistance training in people with chronic neck pain is still unclear. While many studies have demonstrated that cervical stabilization exercises are able to decrease pain and disability and improve movement quality, the effects of combined diaphragmatic resistance training and cervical stabilization exercise in people with chronic neck pain is still unknown. Therefore, the purpose of this study is to investigate the effects of 6 weeks of diaphragmatic resistance training in combination with cervical stabilization exercises in people with chronic neck pain. Participants with chronic neck pain will be randomly assigned to either (1) combined diaphragmatic resistance training and cervical stabilization exercise group or (2) cervical stabilization exercise group. Each group will receive the same cervical stabilization exercises while group (1) will receive additional diaphragmatic resistance training as home program. All participants will have 2 evaluation sessions at baseline and after 6-week intervention for pain, disability and movement quality.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Pain between nuchal line to T1 spinous process lasting over 3 months.

排除标准

  • •First onset acute neck pain.
  • •Surgery history.
  • •Neurological symptoms.
  • •Respiratory, psychiatric and neuromuscular disorders.
  • •Smoking, pregnant, cancer.
  • •Severe anemia or diabetes.
  • •Core exercise in past 12 months.
  • •Spine or chest deformity.
  • •Body mass index (BMI) > 30 kg/m/m.

研究组 & 干预措施

Combined diaphragmatic resistance training and cervical stabilization exercise group

Experimental

Participants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram.

干预措施: Diaphragmatic resistance training (Other)

Combined diaphragmatic resistance training and cervical stabilization exercise group

Experimental

Participants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram.

干预措施: Cervical stabilization exercise (Other)

Cervical stabilization exercise group

Active Comparator

Participants in this group will only receive supervised cervical stabilization exercise.

干预措施: Cervical stabilization exercise (Other)

结局指标

主要结局

Pain intensity using Visual Analog Scale (VAS)

时间窗: Changes from baseline to 6 weeks when participants finish the intervention.

Visual Analog Scale (VAS), a self-reported scale, provides 100 mm line that participants will mark the maximal and averaged pain intensity within past 7 days. The length of the line that participants marked would be the intensity of pain. The minimal value will be 0 mm and maximal value will be 100 mm. The longer the length indicates the higher intensity of pain.

Disability using Neck Disability Index (NDI)

时间窗: Changes from baseline to 6 weeks when participants finish the intervention.

Neck Disability Index (NDI), a self-reported scale, contains 10 sessions of question to evaluating how severe that functional activity level was affected by neck pain. Each session scores ranging from 0 to 5. Total score range from 0 to 50. The higher the score indicates more disability level.

Cervical kinematics

时间窗: Changes from baseline to 6 weeks when participants finish the intervention.

Using optical motion analysis system to assess cervical kinematics for movement quality.

Muscle activation

时间窗: Changes from baseline to 6 weeks when participants finish the intervention.

Using surface electromyogram to assess muscle activation pattern.

次要结局

未报告次要终点

研究者

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

YI-JU TSAI

Professor

National Cheng Kung University

研究点 (1)

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