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.