Methods/Design
This study was funded as a cooperative agreement with
NCCAM/NIH as part of a developmental center
(1U19AT004137) designed to collect preliminary data as
well as increase the research expertise and infrastructure
of the Palmer Center for Chiropractic Research (PCCR).
The central scientific theme of the overall developmental
grant is focused on SM, LBP and mechanisms of
action of SM. The grant includes an NIH appointed
External Advisory Committee (EAC) which meets
annually to discuss the study plans and progress. The
addition of the sham / “doctor’s choice” treatment
group was recommended by the EAC rather than the
wait-list control group proposed in the original grant
application. We also added exploratory aims to assess
the doctor and patient perception of the quality of the
SM delivery. These additional aims will be discussed in
future papers.
Overview
Approximately 219 individuals with acute, subacute or
chronic low back pain are being allocated in a 1:1:1
ratio to receive either 13 HVLA-SM treatments over 6