The Palmer Center for Chiropractic Research
conducts studies at facilities on each Palmer campus,
including the William and Jo Harris Building on
the Davenport Campus. |
Publishing the detailed protocol of a controlled clinical trial
(CCT) in a peer-reviewed journal is becoming the standard.
Investigators at the Palmer Center for Chiropractic Research
(PCCR) recently published the following protocol of a CCT
conducted in the Palmer Research Clinic at the Davenport
Campus. The research team involved members of the PCCR
clinic and biomechanics cores, the Office of Data Management
and Biostatistics and the Office of Clinical Studies in collaboration
with the University of Iowa. The research study was funded
by grant number 1U19AT004137 at the National Institutes
of Health. The full article can be accessed at www.trialsjournal.
com (Wilder et al. Trials 2011, 12:161). This article has been
designated as “highly accessed,” indicating that it is among the
most viewed articles on BioMed Central.
Effect of spinal manipulation on
sensorimotor functions in back
pain patients: study protocol for
a randomised controlled trial
AUTHORS: David G. Wilder, PhD, Robert D. Vining, DC,
Katherine A. Pohlman, DC, MS, William C. Meeker, DC,
MPH, Ting Xia, PhD, James W. DeVocht, DC, PhD, R.
Maruti Gudavalli, PhD, Cynthia R. Long, PhD, Edward F.
Owens, MS, DC, Christine M. Goertz, DC, PhD
Background
Low back pain (LBP) is a recognized public health problem,
impacting up to 80 percent of U.S. adults at some point in their
lives. Patients with LBP are utilizing integrative health care such
as spinal manipulation (SM). SM is the therapeutic application
of a load to specific body tissues or structures and can be divided
into two broad categories: SM with a high-velocity low-amplitude
load, or an impulse “thrust” (HVLA-SM), and SM with a lowvelocity
variable-amplitude load (LVVA-SM). There is evidence
that sensorimotor function in people with LBP is altered. This
study evaluates the sensorimotor function in the lumbopelvic
region, as measured by postural sway, response to sudden load
and repositioning accuracy, following SM to the lumbar and
pelvic region, when compared to a sham treatment.
Methods/Design
A total of 221 participants with acute, subacute or chronic low
back pain were recruited from the Quad Cities area located in
Iowa and Illinois. They were allocated through a minimization
algorithm in a 1:1:1 ratio to receive either 13 HVLA-SM treatments
over six weeks, 13 LVVA-SM treatments over six weeks,
or two weeks of a sham treatment followed by four weeks of full
spine “doctor’s choice” SM. Sensorimotor function tests were performed
before and immediately after treatment at baseline, week
two and week six. Self-report outcome assessments were also collected.
The primary aims of this study are to: 1) determine immediate
pre- to post-changes in sensorimotor function as measured
by postural sway following delivery of a single HVLA-SM or
LVVA-SM treatment when compared to a sham treatment; and 2)
to determine changes from baseline to two weeks (four treatments)
of HVLA-SM or LVVA-SM compared to a sham treatment.
Secondary aims include changes in response to sudden loads and
lumbar repositioning accuracy at these endpoints, estimating sensorimotor
function in the SM groups after six weeks of treatment,
and exploring if changes in sensorimotor function are associated
with changes in self-report outcome assessments.
Discussion
This study may provide clues to the sensorimotor mechanisms
that explain observed functional deficits associated with LBP,
as well as the mechanism of action of SM.
Trial registration
This trial is registered in ClinicalTrials.gov, with the ID number
of NCT00830596, registered on 27 January 2009. The first
participant was allocated on 30 January 2009, and the final
participant was allocated on 17 March 2011.