Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. (2009)

Abstract
OBJECTIVE:
To compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.

DESIGN:
Prospective, single blind, randomised clinical trial.

SETTING:
Single centre trial within a community setting in Brisbane, Australia.

PARTICIPANTS:
179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks’ duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.

INTERVENTIONS:
Six weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.

MAIN OUTCOME MEASURES:
Global improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.

RESULTS:
Foot orthoses produced improvement beyond that of flat inserts in the short term, notably at six weeks(relative risk reduction 0.66,99%confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.

CONCLUSION:
While foot orthoses are superior to flat inserts according to participants’ overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.

My comments:

I like this study because one of the authors, Tom McPoil, was one of my favorite professors when I was at the NAU physical therapy program.  The researchers found foot orthotics were moderately successful in decreasing patellofemoral pain at least in the near term. This is presumably because overpronation of the foot, which is most common in those with patellofemoral pain, is lessened with foot orthotics with arch supports.  While orthotics were better than flat inserts alone, when combined with multimodal physical therapy they did not add any additional improvement.  At 52 weeks out, however, the orthotics were not better than flat inserts and still did not add any additional benefit to the physical therapy treatment. The physical therapy only group had slightly better improvement, though this was not statistically significant.

The physical therapy group included exercises of the legs and hips (relatively low intensity) which I would expect still conferred the greatest benefit.  They also did patellar mobilization, patellar taping, and bio feedback, all of which I expect to provide only psychological benefits.  Interestingly, 40% of the physical therapy group had side effects resulting from the patellar taping, including skin irritation and blistering,  despite excluding participants with known allergies to tape.  “Marked improvement” in all the treatment groups was only found to be in the 50-60% range at 52 weeks out. There is still much to be desired with the treatment protocols in order to fully resolve pain and restore full levels of function in the majority of patients.  Newer research seems to indicate that patellofemoral pain is associated with, and perhaps results from, more proximal strength deficits. In my experience, it is better resolved with a greater use of high intensity progressive resistance exercise of the core, hips, and legs while also utilizing EMS to acutely decrease pain while strengthening faster than can be done with exercise alone.