July 1, 2003

During the influenza epidemic of 1918, patients treated by osteopathic physicians had a better chance of survival than the general population. According to statistics, the mortality rate from influenza cases treated by osteopaths was only 0.23 percent, compared to the national mortality rate of 12 to 15 percent. For flu cases further complicated by the development of pneumonia, the numbers were 10 percent compared to the national average of 25 percent.

The osteopathic medical profession often refers to that collection of case reports as key documentation that osteopathic manipulative therapy is viable in treating pulmonary disorders. Today, the practice of using osteopathic manipulative therapy, or OMT, to treat patients hospitalized with pneumonia has become the exception rather than the rule for the osteopathic medical community.

However, the 1918 study pre-dates the use of antibiotics to treat pneumonia and only in the past few years has the osteopathic medical profession taken on the challenge of showing the benefits of OMT as a complement to other treatments for pneumonia to the larger medical community, which is often skeptical about the benefits of OMT.

To build on favorable results yielded from earlier pilot studies, a two-year, multi-center clinical trial to determine osteopathic manipulative treatmentâ??s effect in the recovery of hospitalized pneumonia patients age 60 and older was launched in June by the national Osteopathic Research Center, housed at the University of North Texas Health Science Center.

What Donald Noll, DO, principal investigator, and a team of OMT specialists from five clinical sites across the nation hope to document on a large scale is further proof of earlier studiesâ?? findings â?? and of the findings of thousands of osteopathic physicians throughout the decades who have used OMT to treat pulmonary disorders.

Big Picture Progress

The studies conducted by Dr. Noll and other researchers in the field have shown OMTâ??s effectiveness in significantly shortening the length of hospital stay and decreasing the amount of antibiotics needed to treat pneumonia. The big picture for this trial, however, has more far-reaching effects than improved healthcare for the elderly.

The study is particularly significant because its $1.5 million in funding comes from a relatively new consortium of osteopathic foundations and other supportive organizations, including the Osteopathic Heritage Foundation of Ohio, the Brentwood Foundation of Ohio, the Foundation for Osteopathic Health Services of Maryland, the Muskegon General Osteopathic Foundation of Michigan, the Colorado Springs Osteopathic Foundation, the Quad City Osteopathic Foundation of Iowa, the Northwest Oklahoma Osteopathic Foundation and the Osteopathic Institute of the South in Georgia.

In 2001, the American Osteopathic Association, the American Association of Colleges of Osteopathic Medicine and the American Osteopathic Foundation created a national Osteopathic Research Center, aimed at fostering nationwide collaborative research in osteopathic manipulative medicine. The groups realized the profession must pool its resources to fund research that proves OMT principles valid, which would allow it to seek larger research grants from the National Institutes of Health and other funding sources.

The groups selected UNT Health Science Center from a field of six competing osteopathic medical schools to be the headquarters for the national center and provided $1.1 million over four years to fund research projects. John Crosby, JD, AOA and AOF executive director, said, â??UNT Health Science Center excelled in all aspects of the selection process, and they have the faculty, facility and financial resources available to support the ORC.â?

The Osteopathic Research Center plans multi-center studies, submits grants and facilitates the work of individual study sites. In its first year, the ORC submitted $6.8 million in grant applications and received $3.2 million in national research awards, including the original funding for the center.

â??One of the main goals of the ORC is to develop large, collaborative projects that link the power of all the colleges and hospitals of osteopathic medicine,â? said Scott Stoll, DO, PhD, director of the ORC. â??Multi-center studies allow schools to pool their resources, resulting in research studies with more statistical power.â?

During a recent visit by the External Advisory Committee, which is charged with monitoring the progress of the ORC, health science center leaders emphasized the importance of the ORC to both the institution and the osteopathic profession as a whole, reiterating the institutionâ??s support of the center. â??This visit provided us an opportunity to discuss the ORCâ??s progress and plan for the future,â? Crosby said. â??Overall, weâ??re pleased with the ORCâ??s development over the past year and look forward to seeing it progress in its efforts.â?

â??Proving the efficacy of OMT in large, scientifically controlled clinical studies could move it into generally accepted use for all mainstream medicine,â? Dr. Stoll said.

Study Specifics

â??Pneumonia is a major health problem, particularly in the elderly,â? said Dr. Noll, an associate professor and chair of internal medicine at Kirksville College of Osteopathic Medicine in Missouri. â??Hospitalized elderly are an especially vulnerable population, with longer average hospital stays, higher hospitalization rates, more complications and higher mortality rates than the general adult population.â?

Specifically, the study will seek to document OMTâ??s associated benefits related to decreased use of antibiotics, shorter hospital stays and better health outcomes, including reduced deaths resulting from pneumonia in elderly hospital patients.

Following strict clinical trial protocol, the subjects recruited for the study will be randomly assigned to one of three groups: patients receiving osteopathic manipulative therapy by an OMT specialist in addition to the normal course of conventional treatment by attending physicians, a control group of patients receiving â??placeboâ? treatments by a specialist in addition to the conventional treatment, and a control group of patients receiving conventional care only.

The patients in the OMT and placebo treatment groups will receive the same care as the conventional care patients, but with additional treatments twice a day, seven days a week by an OMT specialist.

The study protocol for the first group utilizes the same manipulative treatment techniques used in the earlier studies, such as bilateral paraspinal muscle inhibition, bilateral rib raising, diaphragmatic myofascial release, condylar decompression, cervical soft tissue technique, and bilateral myofascial release to the anterior thoracic inlet and the thoracic lymphatic pump. These seemingly complicated manipulative treatments are administered while the patient is lying in bed and last for only about 10 to 15 minutes.

Patients in the control group receiving placebo treatments are treated with a light touch that mimics OMT to the same area of the body, in the same order and for the same duration. The average physician contact time for the control touch group are approximately the same as that for the treatment group, allowing the investigators to measure the difference in benefits of OMT versus the benefits that touching a patient has on its own.

â??There is the possibility that touching the patient has its own effect,â? said Dr. Noll, â??which is separate from the effects of OMT. We want to measure both effects by having control touch and control no-touch groups.â?

Important to maintaining tight protocols for the study is the ability to keep attending physicians and house staff unaware of the patient group assignments. While aware of which patients are participating in the study, they are not told of the patientsâ?? assignments. The patientsâ?? charts include no information about the study treatments, and none of the examinations or treatments by the investigators is done in the presence of the house staff or attending physicians. Even the patients and their families are kept in the dark about their assignments.

Outcomes are quantified by measuring 1) the time until clinical stability of the patientsâ?? blood pressure, heart rate, respiratory rate, temperature and oxygen saturation is reached; 2) improvements in the patientsâ?? ability to eat and mental status; 3) the time until overall clinical stability; 4) changes in leukocytosis, or bacterial count, in the lungs; 5) mortality rate; 6) patient satisfaction; and 7) the rate of recovery.

The pneumonia trial involves five clinical sites, Mount Clemens General Hospital in Michigan; Kennedy Memorial Hospital at the University of Medicine and Dentistry School of Osteopathic Medicine in New Jersey; Osteopathic Medical Center of Texas, which is affiliated with UNT Health Science Centerâ??s Texas College of Osteopathic Medicine; Doctors Ohio Health Hospital; and Northeast Regional Medical Center; which is affiliated with Kirksville College of Osteopathic Medicine.

In addition to Dr. Noll and the ORC support team, each site will have a site research team of the principal investigator, site co-investigator and site research coordinator. The study began in June with training at the study sites by Dr. Noll.

Ultimate Success

The pinnacle for success of the pneumonia study and others conducted through the ORC, though, has more to do with overall acceptance of OMT as a viable medical treatment modality than with the particular outcomes of any one study. With research data to prove its effectiveness, use of OMT by physicians in various specialty areas, integration into patient care processes in hospitals, and coverage of the procedures by insurance companies could become common practice.

So, while the OMT specialists participating in the study are confident that their treatment will improve the care and recovery of a group of patients at a crucial point in their lives, they also know that this study could mean improved care and recovery for thousands, even millions, in the years to come.

â??Any new treatment tool or method that proves effective can mean lower healthcare costs and, most importantly, the potential to relieve suffering,â? Dr. Noll said. â??Should the results of this study provide positive scientific evidence, OMT is in a unique position to be rapidly integrated into common clinical hospital-based practice


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