This summary of a Cochrane review presents what we know from research about the effect of custom-made foot orthoses for the treatment of foot pain;
The review shows that in adults who have had painful pes cavus (high arch), for more than one month custom foot orthoses:
Decreases foot pain after 3 months compared with fake foot orthoses.
The review shows that for people at least 5 years of age and diagnosed with juvenile idiopathic arthritis (JIA), custom foot orthoses:
Reduce foot pain after 3 months compared with supportive shoes, but do not reduce foot pain after 3 months compared with using prefabricated neoprene shoe inserts.
The review shows that in adults with rheumatoid arthritis (RA), custom foot orthoses:
Reduce rearfoot pain after 3 months, compared with doing nothing, but do not reduce foot pain after 3 years, compared with using fake foot orthoses.
May not reduce pain in the metatarsophalangeal joint (where the big toe meets the foot) after 6 weeks or 3 months any more than wearing supportive shoes or using soft non-custom foot orthoses.
The review shows that for people diagnosed with plantar fasciitis (heel pain), custom foot orthoses:
May not reduce foot pain after 3 or 12 months any more than using fake foot orthoses
May not reduce foot pain after 6 weeks or 3 months any more than using night splints to hold your feet in a stretched position while you sleep. However, using custom foot orthoses and night splints together may reduce foot pain.
May not reduce foot pain after 2-3 months or 1 year any more than non-custom foot orthoses
May not reduce foot pain after 6-8 weeks when used along with a program of stretching exercises or night splints.
May not reduce foot pain after 2 weeks any more than a combined treatment of manipulation, mobilisation and stretching.
This review shows that for people younger than 60 years of age with painful hallux vagus (a condition where the base of the big toe bulges out sideways, away from the foot) custom-made foot orthoses:
Reduce foot pain after 6 months compared to no treatment, but may not reduce foot pain after 6 or 12 months compared to surgery.
Safety of custom foot orthoses
We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Reported adverse effects included additional foot pain, ankle instability and skin irritation.
What are custom foot orthoses and what is foot pain?
This review focuses only on custom ('custom-made') foot orthoses, which are defined in this review as contoured, removable in-shoe devices that are moulded or milled from an impression of the foot (for example a plaster cast, three-dimensional laser scan) and fabricated according to practitioner-prescribed specifications.
Foot pain may be experienced following an injury; long-term overuse; infection; or systemic disease involving any tissue of the foot, including bones, joints, ligaments, muscles, tendons, nerves, skin, and nails. Foot pain can be generalised or more specifically diagnosed according to location (for example heel pain), structure (for example tendon or ligament damage) or condition (for example osteoarthritis).
Best estimate of what happens to people with foot pain caused by a high arch who use custom foot orthoses compared to a fake foot orthoses:
After 3 months, a custom-made foot orthoses improves foot pain by 11 more points on a scale of 0 to 100 (possibly as many as 19 points or as few as 3 points).
Best estimate of what happens to people with RA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes or doing nothing:
After 3 months, custom-made foot orthoses improve foot pain by 14 more points on a scale of 0 to 100 (possibly as many as 23 points or as few as 5 points).
After 2 and a half years, custom-made foot orthoses improve foot pain.
Best estimate of what happens to children with JIA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes:
After 3 months, custom-made foot orthoses improve foot pain by 19 more points on a scale of 0 to 100 (possibly as many as 36 points or as few as 3 points).
Best estimate of what happens to people with a painful bunion with hallux valgus who use custom foot orthoses:
After 6 months, custom-made foot orthoses improve foot pain by 9 more points on a scale of 0 to 100 (possibly as many as 17 points or as few as 1 point) compared to doing nothing.
After 6 months, surgery improved foot pain by 10 more points on a scale of 0 to 100 (possibly as many as 18 or as few as 2 points) compared to the custom foot orthoses.
After 12 months, surgery improved foot pain by 17 more points on a scale of 0 to 100 (possibly as many as 25 or as few as 9 points) compared to the custom foot orthoses.
There is limited evidence on which to base clinical decisions regarding the prescription of custom-made foot orthoses for the treatment of foot pain. Currently, there is gold level evidence for painful pes cavus and silver level evidence for foot pain in JIA, rheumatoid arthritis, plantar fasciitis and hallux valgus.
Custom foot orthoses are commonly recommended for the treatment of foot pain.
To evaluate the effectiveness of custom foot orthoses for different types of foot pain.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2), MEDLINE (from January 1966), EMBASE (from January 1980), CINAHL (from January 1982) and the Physiotherapy Evidence Database (PEDro) (to June 2007). We also contacted authors of included trials and known researchers in the field and checked the reference lists of included trials to identify trials. No language or publication restrictions were applied.
Randomised controlled trials and controlled clinical trials evaluating custom-made foot orthoses for any type of foot pain. Outcomes included quantifiable levels of foot pain, function, disability, health-related quality of life, participant satisfaction, adverse effects and compliance.
Two authors independently selected trials, rated methodological quality and cross checked data extraction. Data were analysed separately for different diagnoses of foot pain and follow-up time points.
Eleven trials involving 1332 participants were included: five trials evaluated custom-made foot orthoses for plantar fasciitis (691 participants); three for foot pain in rheumatoid arthritis (231 participants); and one each for foot pain in pes cavus (154 participants), hallux valgus (209 participants) and juvenile idiopathic arthritis (JIA) (47 participants). Comparisons to custom-made foot orthoses included sham orthoses; no intervention; standardised interventions given to all participants; non-custom (prefabricated) foot orthoses; combined manipulation, mobilisation or stretching; night splints; and surgery. Follow up ranged from one week to three years. Custom-made foot orthoses were effective for painful pes cavus (NNTB:5), rearfoot pain in rheumatoid arthritis (NNTB:4), foot pain in JIA (NNTB:3) and painful hallux valgus (NNTB:6); however, surgery was even more effective for hallux valgus and non-custom foot orthoses appeared just as effective for JIA but the analysis may have lacked sufficient power to detect a difference in effect. It is unclear if custom-made foot orthoses were effective for plantar fasciitis or metatarsophalangeal joint pain in rheumatoid arthritis. Custom-made foot orthoses were a safe intervention in all studies.