Chronic Mechanical Neck Pain Clinical Trial
Official title:
Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
Eligible subjects with chronic neck pain will be randomly allocated to one of two
intervention groups: real vs control spinal manipulation. They will receive three
intervention sessions.
H1: Chronic neck pain patients treated longitudinally over a series of three encounters in
one week by random assignment to treatment group with either of the dual delivery procedures
(Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error
rate of self-report of group allocation at exit interview.
H2: Patients treated by the typical-control dual procedure over a typical sequence of
encounters (3 times in one week) will show statistically significant improvement in clinical
outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index
(NDI), range of motion and pressure algometry; compared to those treated by the
control-control dual procedure.
H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no
significant difference in self-report of group allocation or clinical outcome measures.
A total of 372 subjects will be recruited.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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