The Department of Defense (DoD)'s Defense Health Program for fiscal year 2010 includes, for the first time, a Chiropractic Clinical Trial Award "intended to support the rapid implementation of clinical trials that examine the effect of chiropractic clinical treatment either exclusively or as an adjunct to other treatments on health concerns relative to the Warfighter [member of the Armed Forces], including non-surgical orthopedic injury, pain management, smoking cessation, injury prevention, and enhancing fitness for duty." The $7.5 million funding opportunity is being supported by FY 2010 Defense Health Program funds.
According to the program announcement, the award, executed by the Office of the Congressionally Directed Medical Research Programs, "has been created to provide for and report on clinical trials to assess chiropractic treatment on service member groups of the Armed Forces." The program announcement also notes that only "[i]ndependent investigators from the National Institutes of Health or an independent academic institution" are eligible to apply for the research funds.
"We should all remember how hard fought our entry into the DoD was and the resistance we encountered by DoD personnel toward the keeping of clinical outcomes from those early days," commented James Winterstein, DC, president of National University of Health Sciences. "Here we have what appears to be a significant opportunity and we simply cannot let this slip through our fingers. I believe our future as a profession might well reside in outcomes developed within the DoD and VA. Let us not allow this to pass us by."
When asked whether National would be applying for the research award, Gregory Cramer, DC, PhD, dean of research at the university, said that they were "currently investigating the possibility of applying," but noted several potential challenges the university (and other chiropractic educational institutions interested in applying) may face:
"[A]lthough this appears to be an excellent opportunity, the program announcement indicates that an application must include controlled clinical trials and interventional studies on five specific topics (pain management; orthopedic injuries; smoking cessation; reflex and reaction times; and strength, balance, and injury prevention), using distinct sub-populations of military personnel (e.g., special operations forces and combat specialties operating in a combat theater). The application must include studies on all of the above mentioned parameters and subpopulations to be in compliance with the program announcement. Developing the necessary collaborative research relationships with the military administrative structures that serve such specific military subpopulations, designing the clinical trials in collaboration with these groups, and writing a competitive grant application by the August 3 deadline would be a very significant challenge. We are currently contacting individuals in military and civilian (CAM) treatment facilities to determine the feasibility of pursuing this program announcement."
Christie Goertz, DC, PhD, vice chancellor for research and health policy at Palmer College of Chiropractic, also noted potential hurdles while emphasizing the importance of conducting chiropractic studies involving military personnel. By all accounts, Palmer will be applying for the award by the program deadline:
"The proposed funding for clinical trials of chiropractic in the military is a critical issue for the entire profession, as the results from these studies are likely to drive policy decisions related to coverage of chiropractic services in the DoD, VA and beyond. Conducting research in the military can be difficult because their focus is understandably on battle environments, not science per se. There are political issues to overcome, as well as frequent turnover in command personnel and potential participants.
"Twelve years ago I was a consultant to the Department of Defense and we tried for nearly a year to design and implement a clinical trial on chiropractic as part of the DoD Demonstration Project. Ultimately we were not successful, for a number of reasons. However, I think the environment has changed a great deal since that time. There are many great military clinicians and scientists who are dedicated to the evaluation of anything that might be of benefit to the enlisted military personnel they serve.
"Recently Palmer completed a pilot clinical trial evaluating chiropractic care in the army and the military support for that study was very strong. In response to this new initiative, Palmer is partnering with RAND and the Samueli Institute to develop a proposal that we believe will rigorously address the topics outlined in the Program Announcement. It is imperative that this study focus on the right scientific questions and be conducted by an investigative team with experience in the conduct of chiropractic research."
As alluded to by Dr. Cramer, the program announcement clearly stipulates that proposed clinical trials submitted for award consideration must feature both controlled trials "that at a minimum, compare the outcomes of chiropractic treatment, used either exclusively or as an adjunct to other treatments, with conventional treatment" on the aforementioned topics of pain management, orthopedic injuries or disorders that do not require surgery, and smoking cessation, as well as intervention trials that at a minimum, cover "the effect of chiropractic treatment on the reflexes and reaction times of special operation forces; the effect of chiropractic treatment on strength, balance and injury prevention for members of the Armed Forces with combat specialties operating in a combat theater." While applicants can propose a single trial or multiple trials, research must address all required topics utilizing members of the Armed Forces (active duty) as study subjects.
July 16, 2010 is the deadline to submit a letter of intent (pre-application); the application submission deadline is Aug. 2. For more information about the award including complete pre-application and application submission requirements, visit www.grants.gov and click on "Find Grant Opportunities" in the left-hand toolbar. Then search using the keyword "chiropractic."
Many relevant diagnostic signs are not performed deliberately by the examiner or by the patient at the examiner’s direction. They are observed as the patient reacts to their condition. Fortin’s finger sign, Minor’s sign, and Vanzetti’s sign are three examples of this principle.
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