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临床试验/NCT00560807
NCT00560807撤回2 期

Manual Therapy Dosage Factorial Study

McMaster University1 个研究点 分布在 1 个国家开始时间: 2007年11月20日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Quantitative Sensory Testing (QST)

研究概览

简要总结

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
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
  • •conditions that make the provision of neck exercise unsafe

研究组 & 干预措施

A

No Intervention

Zero treatment/3 weeks

B

Active Comparator

Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks

干预措施: Mobilization (Procedure)

C

Active Comparator

Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks

干预措施: Mobilization (Procedure)

D

Active Comparator

Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks

干预措施: Mobilization (Procedure)

F

Active Comparator

Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks

干预措施: Mobilization (Procedure)

G

Active Comparator

Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks

干预措施: Mobilization (Procedure)

H

Active Comparator

Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks

干预措施: Mobilization (Procedure)

J

Active Comparator

Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks

干预措施: Mobilization (Procedure)

K

Active Comparator

Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks

干预措施: Mobilization (Procedure)

L

Active Comparator

Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks

干预措施: Mobilization (Procedure)

E

No Intervention

Zero treatment/6 weeks

I

No Intervention

Zero treatment/12 weeks

结局指标

主要结局

Quantitative Sensory Testing (QST)

时间窗: Within 24 weeks

Neck Walk Index (NWI)

时间窗: Within 24 weeks

Cyclical Reach and Grasp Test (CRGT)

时间窗: Within 24 weeks

Muscle Biology (cytokine analyses)

时间窗: Within 24 weeks

Central Breathing Control Test

时间窗: Within 24 weeks

Neck Disability Index

时间窗: Within 24 weeks

Pain Intensity - Visual Analogue Scale (VAS)

时间窗: Within 24 weeks

Current Perception Threshold (CPT)

时间窗: Within 24 weeks

次要结局

  • Head Flexion Endurance(Within 24 weeks)
  • Disabilities of the Arm, Shoulder, and Hand (DASH)(Within 24 weeks)
  • Pain Threshold and Pain Tolerance Algometry(Within 24 weeks)
  • Quality of Life (SF-36v2)(within 24 weeks)
  • Global Perceived Effect (GPE)(Within 24 weeks)
  • Range of Motion(Within 24 weeks)

研究者

申办方类型
Other

研究点 (1)

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