Manual Therapy Dosage Factorial Study
This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology.
Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect.
All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program.
Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).
Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.
研究概览
研究类型
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Ontario
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Hamilton、Ontario、加拿大、L8S 1C7
- McMaster University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
- pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
- pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
- must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.
Exclusion Criteria:
- arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
- conditions that make the provision of neck exercise unsafe
学习计划
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：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：A
Zero treatment/3 weeks
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|
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有源比较器：B
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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有源比较器：C
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
|
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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有源比较器：D
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
|
|
有源比较器：F
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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有源比较器：G
Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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有源比较器：H
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
|
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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有源比较器：J
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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有源比较器：K
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
|
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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有源比较器：L
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
|
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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无干预：E
Zero treatment/6 weeks
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无干预：I
Zero treatment/12 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Quantitative Sensory Testing (QST)
大体时间：Within 24 weeks
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Within 24 weeks
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Current Perception Threshold (CPT)
大体时间：Within 24 weeks
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Within 24 weeks
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Neck Walk Index (NWI)
大体时间：Within 24 weeks
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Within 24 weeks
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Cyclical Reach and Grasp Test (CRGT)
大体时间：Within 24 weeks
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Within 24 weeks
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Muscle Biology (cytokine analyses)
大体时间：Within 24 weeks
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Within 24 weeks
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Central Breathing Control Test
大体时间：Within 24 weeks
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Within 24 weeks
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Neck Disability Index
大体时间：Within 24 weeks
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Within 24 weeks
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Pain Intensity - Visual Analogue Scale (VAS)
大体时间：Within 24 weeks
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Within 24 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Global Perceived Effect (GPE)
大体时间：Within 24 weeks
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Within 24 weeks
|
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Disabilities of the Arm, Shoulder, and Hand (DASH)
大体时间：Within 24 weeks
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Within 24 weeks
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Pain Threshold and Pain Tolerance Algometry
大体时间：Within 24 weeks
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Within 24 weeks
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Head Flexion Endurance
大体时间：Within 24 weeks
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Within 24 weeks
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Range of Motion
大体时间：Within 24 weeks
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Within 24 weeks
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Quality of Life (SF-36v2)
大体时间：within 24 weeks
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within 24 weeks
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合作者和调查者
合作者
调查人员
- 首席研究员：Joy C MacDermid, PhD、McMaster University
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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