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临床试验/NCT03149302
NCT03149302已完成不适用

Effects of Local Neck Treatment With and Without Tailored Sensorimotor Control and Balance Exercises for Individuals With Chronic Neck Pain: Protocol for a Randomized Controlled Trial

Chiang Mai University2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
2
主要终点
Cervical joint position error

研究概览

简要总结

The sensorimotor disturbance and postural instability have been demonstrated to be associated with neck pain. Specific therapeutic exercise and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed.

详细描述

The sensorimotor (joint position sense and oculomotor control) and postural stability (balance) disturbances have been demonstrated to be associated with neck pain. Specific therapeutic exercise directed to neuromuscular impairments and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed. Currently, it is not known whether the clinician has to train every impairment or can choose between sensorimotor training and balance training in the rehabilitation of neck pain. Different training approaches may have specific influences on the different outcomes and their outcomes will be important to inform the optimal and efficient management of persons with chronic neck pain.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • insidious neck pain for at least 3 months
  • an average neck pain intensity over the past week ≥ 30 mm on a 100 mm visual analog scale (VAS)
  • a score of neck pain and disability ≥ 10/ 100 on the Neck Disability Index-Thai version
  • an absolute error of cervical joint position error > 4.5°
  • an inability to stand in tandem stance with eyes closed for 30 seconds
  • cervical segmental joint dysfunction (pain provoked >2/10 with abnormal tissue resistance)

排除标准

  • a previous history of neck and head injury or surgery
  • known or suspected vestibular pathology
  • vertigo or dizziness caused by underlying pathology in the ear, brain, or sensory nerve pathways (e.g. benign paroxysmal positional vertigo and BPPV)
  • vascular disorders (e.g. a migraine and hypertension)
  • any musculoskeletal or neurological conditions that could affect a balance
  • inflammatory joint disease
  • systemic conditions
  • cognitive impairment
  • taking four or more medications
  • received physiotherapy treatment for their neck disorder in the past 12 months

结局指标

主要结局

Cervical joint position error

时间窗: Change from baseline at immediate, and 3, 6, 12 months follow-ups

The ability to perform an active movement (extension and rotation to the left and right) and return to the starting head position as accurately as possible, using a target on the wall and a laser-pointer attached to a lightweight headband.

Postural sway area

时间窗: Change from baseline at immediate, and 3, 6, 12 months follow-ups

The sway area during narrow stance on firm and soft surfaces with eyes open and eyes closed and during neck torsion maneuver (head turned 45 degrees to the left and right) on firm and soft surfaces, using a swaymeter device.

Postural sway displacement

时间窗: Change from baseline at immediate, and 3, 6, 12 months follow-ups

The sway displacement during narrow stance on firm and soft surfaces with eyes open and eyes closed and during neck torsion maneuver (head turned 45 degrees to the left and right) on firm and soft surfaces, using a swaymeter device.

次要结局

  • Pain location(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Global perceived benefit of treatment(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Neck pain disability(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Dizziness intensity(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Gait speed(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Neck pain intensity(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Pain extent(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Cervical range of motion(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Functional ability status(Change from baseline at immediate, and 3, 6, 12 months follow-ups)
  • Health-related quality(Change from baseline at immediate, and 3, 6, 12 months follow-ups)

研究者

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

Sureeporn Uthaikhup

Principal Investigator

Chiang Mai University

研究点 (2)

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