The challenges of ethical recruitment
of patients into simultaneous clinical
studies in a chiropractic research clinic
AUTHORS: Robert Rowell, D.C.; Dana Lawrence, D.C.; and
Edward Owens Jr., D.C.
Because clinical trials are expensive to conduct, and
because patient recruitment is critically important to
their success, means need to be found to maximize the
recruitment yield when chiropractic institutions conduct
more than one study.
We developed a process that creates an ethical means to bring
other research projects to the attention of individuals who
were excluded from the project for which they originally volunteered.
Once excluded from a research trial, volunteers are
asked if they wish to learn about other studies. If interested
they are given information about other studies and sent home
with instructions to call back if they wish to volunteer.
Consent will be used to take baseline information from the
first study and apply it to the second.
This approach has been approved by the Institutional
Review Board for the institution and implemented in the
Baseline spinal stiffness characteristics
of patients enrolled in a clinical
study of spinal manipulation for low
AUTHORS: Edward Owens Jr., D.C.; James DeVocht, D.C.;
Ram Gudavalli, Ph.D.; David Wilder, Ph.D.; and William
Meeker, D.C., M.P.H.
In this project, a hand-held device was developed to take
measurements of posterior-to-anterior (PAS) spinal stiffness on
patients in a study of spinal manipulation for low back pain.
The device consisted of a plastic rod with a force transducer
mounted at the lower end and a position tracker at the upper
end. The device was pressed into the soft tissue overlying the
spinous processes of each lumbar segment. Linear regression
was used to calculate the force versus displacement relationship,
resulting in a stiffness value in N/mm. 192 patients (89
female, 103 male, average age 40.0 (SD 9.4)) were studied.
The average Roland-Morris Score was 9.7 (SD 3.2) on a 24-
point scale. Initial VAS scores were 55.7/100 (SD 20.9).
Females were on the average 2 N/mm more compliant than
males (P<0.001). Significant correlations were seen between
segmental stiffness and demographic factors: age, gender,
weight and body mass index (BMI). However, no clinical factors
correlated with spinal stiffness, including: chronicity of
complaint, Roland-Morris scores, VAS for pain or lumbosacral
(LS) range of motion. The weight and BMI correlation was
most significant at the lowest lumbar segments.
The PAS system of computer monitored equipment, with
human operation performed well in this clinical study of low
back pain. Spinal stiffness was found to be different between
males and females, and age and BMI were related to PAS.
The William and Jo Harris Building on the
Davenport Campus houses the Palmer Center
for Chiropractic Research.