RANDOLPH AIR FORCE BASE, Tx –
The U.S. Army-Baylor University Doctoral Program in Physical Therapy is partnering with Randolph Air Force Base to conduct a research study here to compare the effects of two physical therapy approaches on controlling pain, function and health care costs for people with knee osteoarthritis.
The study, called "Dosing Exercise and Manual Therapy for Osteoarthritis of the Knee," launched at the Randolph physical therapy clinic April 1.
"Osteoarthritis is caused by the breakdown of cartilage in one or more joints," said Brett Neilson, study coordinator and physical therapist contractor at the Henry M. Jackson Foundation for the Advancement of Military Medicine Inc. "When cartilage loss occurs, changes in structures around the joint, fluid accumulation and bony overgrowth can develop, causing severe chronic pain, loss of mobility and disability."
The purpose of the study is to compare the effects of delivering exercise therapy or exercise therapy supplemented with manual therapy techniques. An additional consideration is whether adding periodic "booster sessions" over the subsequent year further improves pain and physical function at one- and two-year follow-up periods compared to not using booster sessions. Booster sessions are periodic face-to-face follow-up appointments that, in this case, will take place over the course of 1 year following the initial discharge from the supervised therapy program.
The booster sessions are designed to review the patient's current rehabilitation program, troubleshoot any problems with the program and make recommendations for program progression or modification.
"Direct health care costs for osteoarthritis are among the highest in the Military Health System," said Lt. Col. John Childs, associate professor and director of research in U.S. Army-Baylor University doctoral program in physical therapy and principal investigator for the study. "When you factor in the associated indirect costs such as lost productivity and disability, it's a staggering problem. Identifying highly effective non-surgical management strategy for active duty and DoD beneficiaries that are also cost effective can have some enormous implications on downstream cost savings,"
The effects of manual therapy combined with exercise therapy compared to exercise therapy used singularly in reducing pain and improving physical function will also be surveyed. The study will also compare the cost-effectiveness of the manual therapy combined with exercise with or without booster sessions in the management of knee osteoarthritis.
"This study will assist physical therapists in determining which treatments are most effective for individuals with knee arthritis and determine the optimal dose," said Colonel Childs . "In other words, is it better to deliver all of the visits up front or are there some advantages to 'tune-ups' or booster sessions? Perhaps some initial visits with additional booster sessions spread out over time might enhance the recovery so that the results are maintained over a longer period of time."
The patients are split up into four groups - exercise with booster sessions, exercise without booster sessions, exercise and manual therapy without booster sessions and exercise and manual therapy with booster sessions.
The groups are selected by random assignment determined by a computer program through a data reporting system where the intake measures are logged after their demographic questionnaires are filled out. There is no identifying information attached to the assignments.
"Obviously there's no guarantee they're going to see benefits, but every group will receive at least the current standard of care for knee osteoarthritis and exercise therapy," said Mr. Neilson . "Every group is receiving exercise therapy. There is no placebo in this study. No group will receive sub-optimal care. They're going to receive 12 treatment sessions with a licensed physical therapist, so it's highly likely patients will notice a significant improvement in their symptoms regardless of which group they are in."
People cannot participate in the study if they are younger than 40 years old; are scheduled for total knee arthroplasty surgery; have undergone total joint arthroplasty; exhibit uncontrolled hypertension; complain of low back pain or other lower extremity joint pain that affects function at the time of recruitment; have a history of neurological disorders that would affect lower extremity function, such as stroke, peripheral neuropathy, Parkinson's disease and multiple sclerosis; or are pregnant.
How often patients come in to receive treatment depends on the group to which the patient is assigned. The booster group will have 8 appointments within 9 weeks versus the non-booster group, which will have 12 appointments within 9 weeks at a frequency of 1-2 appointments per week.
Patients can find out more information for the study through their primary care provider at Randolph AFB. Potential subjects for the study do not have to be recommended through their primary care manager and are able to go directly to the physical therapy clinic. The Study Coordinator, Mr. Neilson, can be reached by phone at 206-940-9421 or by email at bneilson8@gmail.com.
"You may not be seeing the doctor for your knee pain; you may be seeing them for a cold and happen to have knee pain and arthritis and see the study flyers hanging on the exam room walls. At that time, you can be referred or you can come straight to the physical therapy clinic," said Mr. Neilson. "There is some evidence to suggest that high quality physical therapy for knee arthritis can delay or even prevent future surgery. "