clockwise from bottom right are Members of the Department of Physical Medicine and Rehabilitation, UMDNJ-New Jersey Medical School: Todd P. Stitik, MD, associate professor and director, Outpatient Musculoskeletal/Occupational Medicine; Lisa Schoenherr, research coordinator; Neha Bangia, MD, BS, research assistant; Jong Hyun Kim, MD, PhD, international research fellow; and Miguel Coba, fourth year medical student

Clinical research improves mobility of osteoarthritis patients by Todd P. Stitik

Osteoarthritis, a degenerative condition of synovial joints, is a major cause of pain and functional disability. As this condition is most common in older adults, its incidence is increasing exponentially as the population ages. Osteoarthritis of the knee is particularly devastating as it can severely hamper a person’s mobility, while osteoarthritis involving the shoulder region can significantly impair activities of daily living by limiting the functional use of the upper limb. The non-surgical treatment of osteoarthritis is a clinical research area under active investigation.

We are nearing completion of a clinical trial involving 30 patients with osteoarthritis of the acromioclavicular (AC) joint. This study is the first of its kind to examine the use of sodium hyaluronate (Hyalgan®) injections into the shoulder joint. Hyalgan® is an FDA-approved injectable synovial fluid supplement that relieves pain by restoring the viscosity and elasticity of synovial fluid, by blocking pain receptors and by stimulating the synovial membrane to produce endogenous hyaluronate, a major component of synovial fluid. In this double-blind, randomized, placebo-controlled study with a crossover design, patients received either three Hyalgan® injections or three saline injections under fluoroscopic guidance, to ensure injection accuracy. Depending upon their initial response, some patients were eligible for crossover into the active treatment group. Changes in pain, function, range of motion and strength are being studied. The preliminary data from the research is very favorable.

We are also in the last stages of of a multi-center clinical trial involving a new cyclooxygenase II (COX 2) inhibitor in development. The enzyme COX-2 is responsible for converting arachidonic acid to “inducible” prostaglandins, which produce inflammation and exacerbate tissue injury at the site of injury. We have been participating in this long-term safety study over the last several years. To date, there have been no serious adverse events linked to this medication at the NJMS study site. Patients are placed on this new COX-2 inhibitor as part of treatment for their osteoarthritis and are seen for regularly scheduled physician follow-up visits.
We are currently involved in a multi-center clinical trial involving Hyalgan® knee injections. The purpose of this study is to determine the duration of benefit from three injections compared to the more traditional five injection cycle. During the course of the study, patients receive three or five weekly sodium hyaluronate injections and then are seen for follow-up visits over the course of nine months. This study stemmed from my previous investigator-initiated study on the duration of benefit of either: three injections of Hyalgan®, three injections and a simple home exercise program, or five injections. The research, which was presented at a national physical medicine and rehabilitation conference, showed a duration of benefit of up to one year for all three groups. But participants who received three injections and carried out a simple home exercise program, and those in the five injection group had the best results. The exercises included isometric contractions of the quadriceps muscles known as “quad sets,” and a simple exercise (“wall slides”) that involved standing with the feet at shoulder width in front of a wall against which the patient was leaning and bending at the knees so as to slide down the wall.

I am also the principal investigator of a clinical trial involving the effect of celecoxib (Celebrex) on gait parameters, using a computerized gait testing mat known as the GAITRite. During this three month clinical trial, patients are administered celecoxib at a 200 mg per day dose, in order to compare their gait characteristics before and after taking this medication. The research hypothesis is that the use of celecoxib will normalize a patient’s gait to resemble that of a non-osteoarthritis patient. Data is currently being collected, but a subsection of the data was favorable, and was presented at this year’s Osteoarthritis Research Society International (OARSI) meeting in Boston.

Todd P. Stitik, MD, is an associate professor of physical medicine and rehabilitation at UMDNJ-New Jersey Medical School and is the director of Outpatient Musculoskeletal/Occupational Medicine at UMDNJ-University Hospital. Dr. Stitik attended Rutgers University and received his medical degree from the University of Pennsylvania. He completed an internal medicine residency at New York University and a physical medicine and rehabilitation medicine residency at Kessler Institute for Rehabilitation. Osteoarthritis is his primary clinical and research interest.