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The study was stopped because the study never received funding
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| National Institutes of Health (NIH) | NIH |
| University of Western Ontario, Canada | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | Zero treatment/3 weeks | |
| B | Active Comparator | Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks |
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| C | Active Comparator | Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks |
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| D | Active Comparator | Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks |
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| F | Active Comparator | Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks |
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| G | Active Comparator | Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobilization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Sensory Testing (QST) | Within 24 weeks | |
| Current Perception Threshold (CPT) | Within 24 weeks | |
| Neck Walk Index (NWI) | Within 24 weeks | |
| Cyclical Reach and Grasp Test (CRGT) | Within 24 weeks | |
| Muscle Biology (cytokine analyses) | Within 24 weeks | |
| Central Breathing Control Test | Within 24 weeks | |
| Neck Disability Index | Within 24 weeks | |
| Pain Intensity - Visual Analogue Scale (VAS) | Within 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Perceived Effect (GPE) | Within 24 weeks | |
| Disabilities of the Arm, Shoulder, and Hand (DASH) | Within 24 weeks | |
| Pain Threshold and Pain Tolerance Algometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy C MacDermid, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S 1C7 | Canada |
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| ID | Term |
|---|---|
| D014911 | Whiplash Injuries |
| C536695 | Weyers acrofacial dysostosis |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| H | Active Comparator | Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks |
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| J | Active Comparator | Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks |
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| K | Active Comparator | Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks |
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| L | Active Comparator | Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks |
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| E | No Intervention | Zero treatment/6 weeks |
| I | No Intervention | Zero treatment/12 weeks |
|
| Within 24 weeks |
| Head Flexion Endurance | Within 24 weeks |
| Range of Motion | Within 24 weeks |
| Quality of Life (SF-36v2) | within 24 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |