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Update on clinical trials

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Assessment of Chiropractic Treatment studies update

The Department of Defense (DoD) Congressionally Directed studies are in full swing. The Assessment of Chiropractic Treatment 1 (ACT 1) study, assessing the pain and functional outcomes of chiropractic plus conventional medical care compared to those receiving conventional medical care alone, had enrolled 260 participants as of October 2013. One of the three sites for the study, the Naval Medical Center San Diego, has already reached 50 percent of its recruitment goal of 250 research participants. The Naval Hospital Pensacola site, as well as the Walter Reed National Military Medical Center (WRNMMC) site, are extremely active and recruitment is going well. All three sites are working toward enrolling 250 participants each.

Additionally, a new project manager has been hired to work with Bill Morgan, D.C., West ’85, and Terrence Kearney, D.C., West ’89, to manage the ACT 1 study at WRNMMC. The former site project manager has accepted and begun work as the Clinical Project Manager II at the Palmer Center for Chiropractic Research on the Davenport Campus.

The ACT 2 clinical study is being conducted at Ft. Campbell/ Blanchfield Army Community Hospital in Kentucky. This study is designed to assess the effect of chiropractic treatment on military readiness by evaluating pre- and post-treatment differences in reaction and response times in the special population. The study team has finalized its testing protocol and has full support from the command and key study personnel at the Army base. Final Institutional Review Board (IRB) approval is pending. Once all approvals are received, the site will begin recruiting participants.

The ACT 3 study is a randomized clinical trial designed to detect differences in strength, balance and low back pain recurrence in members of the armed forces who are eligible for deployment following either standard chiropractic care or a sham chiropractic intervention. This study is being conducted at Madigan Army Medical Center (MAMC) in Tacoma, Wash. Study investigators conducted a pre-study site visit in August 2013 to discuss recruitment strategies and study logistics with the chiropractic team at MAMC. The study protocol will be submitted to the IRB at MAMC this winter.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA) update

The COCOA clinical trial was completed in March 2013. The study team is conducting data analysis and writing up the study findings. Several articles were published during the trial, including:

  • Study protocol: http://tinyurl.com/mslz71f.
  • Focus group study: http://tinyurl.com/focus-grp-study.

A presentation on the study made at the March 2013 Association of Chiropractic Colleges–Research Agenda Conference. Presentation authors were: Stacie Salsbury, R.N., Ph.D., Palmer Center for Chiropractic Research (PCCR); Kevin Lyons, Ph.D., Thomas Jefferson University; Cynthia Long, Ph.D., PCCR; Maria Hondras, D.C., M.P.H, PCCR; Robert Vining, D.C., PCCR; Lisa Killinger, D.C., Diagnosis and Radiology, Davenport Campus; and Christine Goertz, D.C., Ph.D., PCCR. The presentation was titled “Doctors of chiropractic self-reported practice patterns and attitudes toward interdisciplinary co-management of older adults with low back pain.”

Manual Cervical Distraction (MCD) manipulation study update

The MCD clinical trial ended in October 2013, and data analysis is being conducted with a plan to publish findings in summer 2014.

A presentation on the study was made at the November 2013 International Mechanical Engineering Congress and Exposition. Presentation authors were: M. Ram Gudavalli, Ph.D., PCCR: Vikas Yadav, M.S., Auburn University; Robert Vining, D.C., PCCR; Michael Seidman, D.C., PCCR; Stacie Salsbury, R.N., Ph.D., Paige Morgenthal, D.C., PCCR; Avinash Patwardhan, Ph.D., Loyola University Chicago School of Medicine; and Christine Goertz, D.C., Ph.D., PCCR. The presentation was titled “Development of force-feedback technology for training clinicians to deliver manual cervical distraction.”

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