Self-administered Program in Chronic Neck Pain
2018年10月10日 更新者：Marie Carmen Valenza、Universidad de Granada
Effects of a Self-administered Program in Chronic Neck Pain Patients
Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures.
The onset and course of this pain are influenced by environmental and personal factors.
Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.
研究概览
详细说明
Neck pain is the fourth leading cause of disability worldwide causing an enormous impact on individuals and their families, communities and healthcare systems.While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness.
No previous study has used foam roller in patients with neck pain.
In addition, it has been suggested that neurodynamic interventions provide a peripheral stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal transport and nerve conduction.
It was hypothesized that a self-administered intervention focused on myofascial release of main muscles related to neck pain and upper-limb active neurodynamics could reduce the presence of active trigger points and pain, improving functionality and active mobility.
研究类型
介入性
注册 (预期的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Granada
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Granada.、Granada、西班牙、18071
- Faculty of Health Sciences. University of Granada.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Chronic neck pain (at least 3 months' duration) not related to trauma of at least 3 on a visual analogue scale
- Participants' symptoms had to be reproduced by median nerve upper-limb neurodynamic test.
Exclusion Criteria:
- Exclusion Criteria:
- Whiplash related neck pain
- Previous cervical surgical intervention
- Cognitive impairments which prevent them to follow instructions
- Visual or acoustic limitations
- Physical therapy in the previous six months
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Experimental group
Patients allocated to the experimental group were included in a self-administered program combining self-myofascial release using foam rollers and roller balls and active upper limb neurodynamic exercises.
It consisted of three sessions of 50-60 minutes per week for 4 consecutive weeks.
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One session was a session supervised by a physical therapist in the Faculty of Health Sciences.
This session took place in groups of three or four people.
All participants had to follow the physiotherapist instructions about the correct way to do the exercises with the foam roller or ball and nerve mobilizations of upper limbs.The other two weekly sessions were performed at home, following the instructions given by the physiotherapist in session.
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无干预：Control group
Those patients allocated to the control group received a booklet with information regarding neck pain and explaining basic exercises for active mobilization and stretching with pictures and a short text.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Trigger points examination
大体时间：Change from baseline trigger points examination at 4 weeks
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Trigger points will be explored bilaterally by a blinded assessor in suboccipital, scalene, levator scapulae and upper trapezius muscles
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Change from baseline trigger points examination at 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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健康相关的生活质量
大体时间：4 周时与基线健康相关的生活质量的变化
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与健康相关的生活质量将通过 euroQol-5D 进行测量。
它包含两个部分，一个描述部分和一个评估部分。
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4 周时与基线健康相关的生活质量的变化
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恐惧回避信念
大体时间：4 周时基线恐惧回避信念的变化
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恐惧回避信念将通过恐惧回避信念问卷 (FABQ) 进行评估。
它由 16 个与身体活动（前 5 个项目）和工作（后 11 个项目）相关的句子组成。
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4 周时基线恐惧回避信念的变化
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焦虑和抑郁
大体时间：4 周时基线焦虑和抑郁的变化
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焦虑和抑郁通过医院焦虑和抑郁量表 (HAD) 进行评估。它包含描述抑郁症状的 14 个项目（7 个项目）和焦虑（7 个项目）
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4 周时基线焦虑和抑郁的变化
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Pain severity
大体时间：Change from baseline pain at 4 weeks
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Pain will be assessed using the Brief Pain Inventory.
It measures the degree of interference of pain with various aspects of life, including mobility and social activities (reactive pain) and pain severity (sensory pain).
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Change from baseline pain at 4 weeks
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Functionality
大体时间：Change from baseline functionality at 4 weeks
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Functionality will be assessed by the Neck Outcome Score.
This is a reliable, valid and responsive measure of self-reported disability for patients with neck pain.
It includes 34 items divided into 5 subscales: Mobility, symptoms, sleep disturbance, every day activity and pain and participation in everyday life.
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Change from baseline functionality at 4 weeks
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Cervical range of motion
大体时间：Change from baseline cervical range of motion at 4 weeks
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Cervical range of motion will be measured using a cervical goniometer.
Subjects perform neck movements to the fullest extent of their mobility of flexion, extension, right and left lateroflexion, and right and left rotation.
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Change from baseline cervical range of motion at 4 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月1日
初级完成 (预期的)
2018年11月1日
研究完成 (预期的)
2019年2月1日
研究注册日期
首次提交
2018年10月8日
首先提交符合 QC 标准的
2018年10月8日
首次发布 (实际的)
2018年10月10日
研究记录更新
最后更新发布 (实际的)
2018年10月15日
上次提交的符合 QC 标准的更新
2018年10月10日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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