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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
319
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada
Group registration
Participants will be asked to identify which of the two interventions they feel they received.
Time frame: At exit assessment following the third intervention session
Pain severity
Pain scores on the PROMIS pain severity instrument.
Time frame: 1. at baseline, and 2. At exit assessment following the third intervention session
Improvement
Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.
Time frame: At exit assessment following the third intervention session
Disability
Participants will score the The Neck Disability Index (score out of 50).
Time frame: 1. at baseline, and 2. At exit assessment following the third intervention session
Tenderness
Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.
Time frame: 1. at baseline, and 2. At exit assessment following the third intervention session
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