Benefit of Adding Stretching to Standard Intervention For Patients With Nonspecific Mechanical Neck Pain
2019年10月9日 更新者：Everett Lohman、Loma Linda University
The purpose of this study is to assess the benefit of adding stretching exercises to cervical mobilization and cervical range of motion exercises on cervical range of motion, pain, pain threshold, level of disability and patient satisfaction for patient with non-specific mechanical neck pain
研究概览
详细说明
All recruited participants will sign a statement of informed consent.
Subjects were randomly divided into two groups (combined intervention group and standard intervention group).
The following questionnaires were completed in the following order: Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), and Global Rating of Change Scale (GROC).
Next, Cervical Range of Motion (ROM) and Pain threshold were measured for both groups.
The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
The standard intervention group received cervical mobilization and home program (ROM exercises).
研究类型
介入性
注册 (实际的)
43
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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California
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Loma Linda、California、美国、92354
- Loma Linda U
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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 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- The participant will be eligible to participate in the study if he or she is between 18 and 60 years of age, had non-specific neck pain for at least 2 weeks
Exclusion Criteria:
- Participants will be excluded from the study if they had one or more of the following conditions: had previous surgery in cervical spine area, chronic disease such as diabetes, vertigo, dizziness, fracture of the cervical vertebra or scapula, multiple sclerosis, osteoporosis, rheumatoid arthritis or osteoarthritis as approximately 60% of people who aged between 50-60 years will have osteoarthritis.
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：The combined intervention group
The combined intervention group will receive the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).
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The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has licensed from the California Board of Physical Therapy.
The cervical passive mobilization were selected by the physical therapist based on the participant's condition.
Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor and interspinous muscles .AROM Exercise were performed 10 repetitions 3-4 times daily.
The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers.
The subject was then instructed to rotate to one side as far as possible and return to neutral.
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有源比较器：The standard intervention
The standard intervention group will receive cervical mobilization and home program (ROM exercises).
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The standard intervention group will receive cervical mobilization and home program (ROM exercises). Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition. Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral . |
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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Cervical Range of Motion
大体时间：Participants ROM measurement at baselines
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
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Participants ROM measurement at baselines
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Cervical Range of Motion
大体时间：Participants ROM measurement at week 2
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
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Participants ROM measurement at week 2
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Cervical Range of Motion
大体时间：Participants measurement at week four
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.
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Participants measurement at week four
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Cervical Range of Motion
大体时间：Participants ROM measurement at week 8
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The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.
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Participants ROM measurement at week 8
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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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Numeric Pain Rating Scale
大体时间：NPRS score at baseline
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Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
The standard error is correct as stated.
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NPRS score at baseline
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Numeric Pain Rating Scale
大体时间：NPRS score at week two
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Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
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NPRS score at week two
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Numeric Pain Rating Scale
大体时间：NPRS score at week four
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
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NPRS score at week four
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Numeric Pain Rating Scale
大体时间：NPRS score at week eight
|
Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight.
It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals.
The zero represents no pain while a 10 represents very severe pain that participant cannot stand.
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NPRS score at week eight
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Neck Disability Index
大体时间：NDI score at baseline
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at baseline
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Neck Disability Index
大体时间：NDI score at week two
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week two
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Neck Disability Index
大体时间：NDI score at week four
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week four
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Neck Disability Index
大体时间：NDI score at week eight
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Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight.
It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50.
A score of zero (0) represents no disability while a score of 50 represents severe, full disability.
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NDI score at week eight
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Global Rating of Change
大体时间：GROC score at week two
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The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four, and eight.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
The points are scores on a scale (-7-0-+7 = 15 point scale).
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GROC score at week two
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Global Rating of Change
大体时间：GROC score at week four
|
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and eight.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
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GROC score at week four
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Global Rating of Change
大体时间：GROC score at week eight
|
The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and right.
The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change.
The negative and positive means the patient condition worsens or improves respectively.
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GROC score at week eight
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Pressure Pain Threshold
大体时间：Pressure Pain Threshold score at baseline
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four, and eight.
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Pressure Pain Threshold score at baseline
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Pressure Pain Threshold
大体时间：Pressure Pain Threshold score at week two
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week two
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Pressure Pain Threshold
大体时间：Pressure Pain Threshold score at week four
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week four
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Pressure Pain Threshold
大体时间：Pressure Pain Threshold score at week eight
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Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.
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Pressure Pain Threshold score at week eight
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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。
调查人员
- 首席研究员：Everett B Lohman、Loma Linda U
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)
2016年8月24日
初级完成 (实际的)
2018年1月8日
研究完成 (实际的)
2018年1月8日
研究注册日期
首次提交
2017年6月13日
首先提交符合 QC 标准的
2017年6月20日
首次发布 (实际的)
2017年6月21日
研究记录更新
最后更新发布 (实际的)
2019年10月31日
上次提交的符合 QC 标准的更新
2019年10月9日
最后验证
2019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.
combined intervention group的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的