Physician Led • Outcomes Centered • Patient Focused

Journal Club Review: The use of orthotics to control leg and knee pain with activity

 Mills K, Blanch P, Dev P, Martin M, Vicenzino.  A Randomized Control Trial of Short-Term Efficacy of In-Shoe Foot Orthoses Compared With a Wait-and-See Policy for Anterior Knee Pain and the Role of Foot Mobility. Br J Sports Med 2012;46:247-252.
Hirschmuller A, Baur H, Muller S, Helwig P, Dickhuth H-H, Mayer F.  Clinical Effectiveness of Customized Sport Shoe Orthoses for Overuse Injuries in Runners:  A Randomized Controlled Study.  Br J Sports Medicine 2011;45:959-965.

Custom arch supports can be costly, and people spend a lot of money (millions) on them each year.  Do they work though?  Previous recent studies1,2 suggest that they do, and two studies published in the British Journal of Sports Medicine over the last year reinforce this.

In a study out of Australia published this year, investigators evaluated the effect of orthotics in patients with anterior knee pain (pain coming from the kneecap, or patella).  In this study, forty patients with anterior knee pain were randomized to run in shoes with orthotics or shoes alone (the control group).  No additional treatment was prescribed so that a true treatment effect could be identified.  Patients selected for this study had to be between the ages of 18 and 40, have had pain with activity that was not caused by injury for longer than six weeks and an examination by a physician that met appropriate criteria.  Patients also had to meet two of the following criteria, which have been previously identified as being associated with a higher likelihood of treatment success:

  • A measurable tendency for increased foot width when moving from non-weight-bearing to standing
  • Pain severity of low to moderate degree
  • Age older than 25 years
  • Height shorter than 165 cm (5 feet, 5 inches).

Patients with hip, pelvis or back pain, prior knee damage or patellar tendonitis, prior lower extremity surgery, a history of physical therapy for knee pain in the last three years or with foot conditions that would prohibit use of orthotics were excluded.

Each patient was asked to fill out various validated pain and function surveys at baseline.  Subjects were tested on a treadmill with orthotics of varying firmness to find the most comfortable insert for them.  Both the orthotic and control groups were brought back at the end of six weeks and re-evaluated.

Patients with anterior knee pain who had been issued orthotics had statistically greater improvement in function than the control group, with 79% noting “improvement” or “marked improvement” and nearly half of the group (47.4%) noting “marked improvement.”  Patients with foot widening upon standing experienced a “marked improvement” in 78% of cases.  Only 1/19 control subjects perceived relief by the end of the study period.

This study is helpful because it would suggest that patients with anterior knee pain have a 50% chance of obtaining good pain relief from nothing more than the use of appropriate orthotics.  In other words, one patient for every two patients being treated should get good relief.  If the patient is clinically examined and an effort is made to determine if the patient has a foot type that would potentially respond better, the odds of effective treatment from orthotics would seem to improve even more.  One drawback to this study is that it was not blinded to the patient, meaning that all patients knew whether they were being treated or not, which introduces the potential for placebo effect.


Our second study, this one from Germany, attempted to look at the effectiveness of orthotics for runners with lower limb overuse injuries (shin splints, Achilles tendonitis, Plantar fasciitis, anterior knee pain, IT band syndrome, etc).  The most common diagnosis in this group was Achilles tendonitis, followed by patellar tendonitis.  Runners between 18 and 60 years of age with symptoms in one leg and a history of running over twenty miles per week were offered to participate in the study, assuming no history of lower extremity or spine surgery, recent traumatic injury or ongoing therapies for the current complaint within the last six months.

Patients in this study also were asked to fill out several surveys validated to measure pain and function.  Each participant was given a training diary to complete and was asked to document distance, duration and training intensity for each run session.  Functional surveys were filled out at the end of each week.  Data was collected for two weeks, at which time, groups were randomized to run in either generic orthotics or their standard running shoe.  Orthotic compliance was monitored, with use in at least 80% of all training sessions required.  After eight weeks of treatment, patients were re-evaluated.

Analysis of data showed that there was a statistical improvement in the orthotic group over the course of the study, with measurable improvements in both disability and pain.  Patients in the control group had significant increases in pain and disability over the treatment period, with no ill effects relating to the use of the orthotics.  Of note, there was a slight temporary increase in symptoms in the orthotic group during the first week of the study that reversed by week two and then continued to trend toward improvement.  This emphasizes the importance of laying out proper expectations for patients to minimize the likelihood that they will stop using their orthotics too soon.

Thus, it would appear that orthotics do offer a significant likelihood of pain relief for commonly painful problems involving the legs and feet.  A quick check of publically-available data shows that it is not uncommon for Good Feet Store franchises to have annual revenues of between $500,000 and one million dollars, with patients spending upwards of $1000 for orthotics.  That’s a lot of money that people are shelling out in an effort to control foot or leg pain. We think that’s crazy.  At Stadia, our custom orthotics are priced at $200* and always comes with a no-question return policy of 45 days from the time of the order or about 35 days from the time that the orthotics arrive.  No appointment is necessary to order these either, though if you are struggling with pain, we would always suggest that a physician evaluation is wise.


1Barton CJ. The immediate effects of foot orthoses on functional performance in individuals with patellofemoral pain syndrome. Br J Sports Med 2011;45:193-7.

2Collins N. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome:  randomized clinical trial. BMJ 2008;337:a1735.

*Price subject to change due to a change in our costs.

Click either of these for more info on orthotics offered at Stadia Sports Medicine:

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