The purpose of this study is as follows:
- To undertake a 18 week, double-blind, randomized crossover clinical trial in patients with patellofemoral osteoarthritis to determine whether provision of patellofemoral bracing leads to lower pain scores during the time of this research study procedure than during the use of a placebo research study procedure; and
- To perform a 6 month open label follow-up study to track use and effectiveness of the research study procedure.
We propose a double blind, randomized crossover trial to assess the effect of patellofemoral brace on knee pain among patients with patellofemoral osteoarthritis. The primary outcome will be knee pain as assessed by the VAS scale. A brace provides many features that may be therapeutic such as increased proprioceptive input, improved stability, and perhaps inhibition of knee flexion so as to avoid painful positions. Instead of these, it is our goal in this study to evaluate the therapeutic effect of a patellar brace- to test whether changing the tracking of the patella improves pain. Because of the other potential therapeutic effects of a brace listed above, we will also use a brace in the control research study period, one which provides the other benefits but not the biomechanical effects. The two research study procedure will be as follows: RESEARCH STUDY PROCEDURE A (CONTROL) a neutral brace without the donut (buttress) or realigning strap and RESEARCH STUDY PROCEDURE B (ACTIVE) the same patellofemoral brace with the donut and realigning strap.
Primary Outcome Measures:
- Change in pain on the VAS. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- WOMAC, KOOS, Physical function, Pain with activity, Patient Assessment, SF36, Analgesic Use, Blinded knee, Physician Assessment, Functional performance, X-ray, Physical activity, PASE, and Knee strength [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
80 |
| Study Start Date: |
December 2006 |
| Estimated Study Completion Date: |
July 2009 |
| Estimated Primary Completion Date: |
December 2008 (Final data collection date for primary outcome measure) |
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1: Experimental
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Device: Knee brace
PF realigning knee brace
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2: Placebo Comparator
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Device: Knee brace
Non-aligning knee brace
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Interventions that alter load distribution across the patellofemoral joint, such as patella taping may be helpful in alleviating symptoms. While patellar taping has been shown to be efficacious as an intervention for knee OA and patellofemoral OA more specifically, taping has not been widely adopted clinically and is not likely to be disseminated as a intervention in the future. Taping is complicated to administer, it is difficult to educate the patient about ongoing application, and there is no long-term study assessing its efficacy. Skin irritation occurs in a large proportion of subjects, and removal of the adhesive tape is uncomfortable. Bracing of the patellofemoral joint gets around the limitations of taping --- it is easy to put on and does not cause skin irritation. Given the pressing need for an effective intervention for PF OA, we propose to test whether provision of patellofemoral bracing was effective for relieving pain in symptomatic PF OA.
Purpose
