Background: Patellofemoral syndrome is a common condition caused by stress in the patellofemoral joint that is characterized by pain behind or around the patella. It may be exacerbated by relatively weak quadriceps muscles, and by activities such as squatting, running, and walking down stairs. Therapies to correct it include foot orthotics, physical therapy, and various modalities of knee bracing and taping. There have been no high-quality trials comparing orthotic use with other treatment modalities. Collins and colleagues studied non-custom orthotic use with or without physical therapy on the short- and long-term outcomes of patellofemoral syndrome.

The Study: This single-blind, randomized clinical trial followed 179 volunteers for 12 months. Patients between 18 and 40 years of age with subacute anterior or retropatellar knee pain for at least six weeks were eligible. Those using anti-inflammatory drugs, with previous knee surgery, effusion, concomitant back or hip pain, or any contraindication to foot orthotics or physical therapy were excluded. Participants were randomized to foot orthotics, flat inserts (used as the control), physical therapy, or foot orthotics plus physical therapy. Global improvement, knee pain severity in the past week, and the functional index questionnaire were assessed at baseline and at six, 12, and 52 weeks after randomization.

Results: Success was measured as marked or moderate improvement on the categorical scales and as improvement by millimeters along the continuous visual analogue scale of global improvement. Foot orthotics were significantly better than the flat inserts at six weeks, with a number needed to treat of 4. Foot orthotics and physical therapy were equally effective at six and 12 weeks, and combining orthotics with physical therapy did not improve outcomes. At 52 weeks, all groups had similar clinical improvement without significant differences among the groups. Few patients were lost to follow-up, with 92, 90, and 96 percent of participants assessed at the six-, 12-, and 52-week evaluations, respectively. Mild side effects such as blisters and foot discomfort were more common in the orthotics group (72 percent) and orthotics plus physical therapy group (49 percent) than in the flat insert group (38 percent), and some reported reactions to daily patellar taping (41 percent in physical therapy, 39 percent in the orthotics plus physical therapy group).

Conclusion: The authors conclude that non-custom orthotic inserts lead to faster improvement in patellofemoral syndrome than flat inserts and are equally effective as physical therapy in the short term. Adding orthotics to physical therapy does not improve outcomes.