The Effects Of A Cetylated Fatty Acid Topical Cream On Functional Mobility And Performance In Patients With Osteoarthritis
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Nicholas A. Ratamess, William J. Kraemer, FACSM, Jeffrey A. Anderson, David P. Tiberio, Michael E. Joyce, Barry N. Messinger, Duncan N. French, Matthew J. Sharman, Martyn R. Rubin, Ana L. Gómez, Jeff S. Volek, Carl M. Maresh, FACSM, and Robert L. Hesslink Jr.
Human Performance Laboratory, University of Connecticut, Storrs, CT
Imagenetix, Inc., San Diego, CA
Osteoarthritis (OA) is a progressive, degenerative joint disease estimated to affect more than 21 million individuals in the United States. The Arthritis Foundation reports that arthritis is the leading disability of Americans resulting in over 39 million medical visits per year and $65 billion in medical expenses and lost wages. OA is characterized by enzymatic and mechanical breakdown of the extracellular matrix, leading to degeneration of articular cartilage. The most common symptoms are pain and stiffness with an associated reduction in joint range of motion. Accompanying pain and stiffness are limitations to normal activities of daily living such as getting up from a chair, walking, balance (e.g., greater postural sway), and ascending/ descending stairs. In response to pain and stiffness, patients with OA tend to reduce activity which further induces muscle atrophy and poses greater limitations to performance of activities of daily living. Thus, an intervention that targets pain reduction is necessary in order to improve the quality of life of patients with OA.
Considering the increasing incidence of OA in the elderly population, pain reducing medications such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and COX-2 inhibitors have been common treatments. However, there is a need for alternative products that benefit patients with OA without harmful side effects. Cetylated monounsaturated fatty acids have been shown to provide protection against arthritis in rats and increased knee range of motion and reduced pain in patients with OA. However, the effects of topical cetylated fatty acid treatment on various activities of daily living (i.e., ascending/descending stairs, walking, balance, rising from a chair) remain unknown. Therefore, the purpose of the present study was to investigate the effects of using a newly developed topical cream consisting of a blend of cetylated fatty acids on functional performance in patients with OA. We hypothesized that use of a topical cetylated fatty acid cream would result in improved physical function in patients with OA.
The purpose of this investigation was to examine the effects of using a topical cream consisting of cetylated fatty acids on functional performance in patients diagnosed with osteoarthritis (OA) of one or both knees. Forty patients, 34 women and 6 men, diagnosed with knee OA were matched and randomly assigned (using a double-blind study design) to 1 of 2 topical treatment groups: 1) cetylated fatty acid (CFA) (N=20; age = 62.7 ± 11.7 yrs); or 2) placebo (P) group (N=20; age = 64.6 ± 10.5 yrs). Patients were tested on 3 occasions: 1) baseline (T1) period prior to cream treatment, 2) then after 3 days without treatment, participants applied an initial treatment to the affected areas and the outcome measures were obtained after 30 min of application (T2), and 3) following a 30-day treatment period consisting of cream application twice per day (T3). Assessments included 40-sec standing center of pressure (COP) on a force plate to measure postural sway, timed up-and-go from a chair, timed stair climbing ability (up and down 11 steps), the medial step-down test to assess muscle strength and endurance, and the single-leg anterior reach (a measure of unilateral strength and balance). Test-retest reliabilities for all tests ranged from 0.94 to 0.99. For stair climbing ability and the up-and-go tests, significant decreases in time were observed at T2 (-1.39 and -0.66 sec, respectively) and T3 (-1.78 and -1.03 sec, respectively) compared to T1 in CFA only. These differences were significant between groups (P < 0.001). A significant reduction (-0.07 m) was observed for movement of COP during a 40-sec standing test in CFA only. In the single-leg anterior reach, significant improvements were observed for both legs in CFA and only the left leg in P. However, the improvements observed in CFA were significantly greater than P for both legs (5.1 and 4.4 cm vs. 0.8 and 1.8 cm respectively for the right and left legs). For the medial step-down test, both groups significantly improved at T2 and T3. However, the improvement in the right leg (the leg most affected by OA in our sample) was significantly greater in CFA at T3. These results indicate that the use of a topical cream containing cetylated fatty acids is an effective treatment for improving physical function in patients with OA. Specifically, patients with OA had significantly less standing postural sway, improved ability to ascend and descend stairs, improved ability to rise from a chair, walk, and sit down, and greater unilateral balance, strength, and endurance.
Patients diagnosed with OA by a physician were matched for body mass, age, gender, and OA history and randomly assigned to 1 of 2 topical treatment groups in a double-blind manner receiving either: 1) a cream consisting of a blend of cetylated fatty acids (CFA); or 2) a placebo (P) cream. Patients were tested for functional performance on 3 occasions: 1) prior to treatment (T1), 2) 30 min after patients'' first treatment with a cream to measure the initial response, and 3) after a 30-day topical cream treatment period. Patients were instructed to apply a standardized amount of cream to both knees. The topical cream was applied to the anterior, posterior, and lateral aspects of both knees over a 10-12 cm area twice per day (at a standardized morning and evening time point) for 30 days. In addition, each patient maintained his/her current food and beverage intake throughout the 30-day period via 3-day diet records and nutritional counseling.
|Body Mass (kg)||85.6±20.6||84.6±21.8|
Assessments of Physical Function
Timed Up-And-Go: the time it took to rise from a chair, walk 3 m, turn around, return to the chair and sit down
Stair Climbing: the time it took to ascend and descend a flight of eleven 13.5 cm steps
Unilateral Anterior Reach: the ability to extend one leg forward as far as possible while balancing on the opposite leg
Medial Step-Down: the number of times a patient was able to step down from a 11.4 cm elevation, lightly touch the foot to the floor, and return to the starting position
Postural Sway: movement of the center of pressure of the patient was measured during a 40-sec period of quiet standing on a force plate
Statistical evaluation was accomplished using a 2 X 3 analysis of variance with repeated measures. Subsequent pairwise differences were determined using a Tukey post-hoc test when appropriate. Significance was set at P = 0.05.
Use of a cetylated fatty acid topical cream produced significant improvements in stair climbing ability, standing balance, local muscular endurance, and ability to rise from a chair and walk in patients with knee OA