Whiplash Injuries Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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