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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 research clinic.

Baseline spinal stiffness characteristics of patients enrolled in a clinical study of spinal manipulation for low back pain

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.
William and Jo Harris Building
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