Table 1 Summary of studies that have used a sham orthosis as a control intervention when evaluating the effectiveness of foot orthoses

Budiman-Mak et al., 1995 [8]

102 participants with rheumatoid arthritis.

Customised orthosis constructed from Rohadur with rearfoot and forefoot posting.

Molded thin leather shell with naugahyde top cover.

At 3 years, 25% of sham group had progression of their HAV angle compared with 10% for the treatment group (statistically significant).

Burns et al., 2006 [9]

154 participants with painful cavoid feet.

Customised orthosis constructed with a 3 mm polypropylene shell and full length Poron^® and Kashmeer top cover.

Full-length flat insole made from 3 mm latex foam with Kashmeer top cover.

At 3 months, foot pain and function scores (scale, 0–100) improved more with custom foot orthoses than with the sham, difference, 8.3 points and 9.5 points respectively (statistically significant). The customised orthosis reduced peak plantar pressures by 26% compared with 9% in the sham group (statistically significant).

Burns et al., 2009 [10]

61 participants with diabetes mellitus.

Customised orthosis constructed from a mesh of 8 mm Polylux, 8 mm Combilux, 2.3 mm Memorix, 3 mm Remember, and a 0.7 mm Calbino microfiber top cover (Thanner GmbH, Germany).

Removable flat, non-supportive 4 mm EVA shoe innersoles covered with a 0.7 mm Calbino top cover.

At 8 weeks, the customised and sham orthosis both provided similar improvements in foot pain and function scores. Compared to the sham group, customised group reduced peak pressure across the whole foot, 18% to 8% respectively (statistically significant).

Collins et al., 2009 [11]

179 participants with patellofemoral joint pain.

Prefabricated orthosis (Vasyli) made from low, medium or high density EVA. Some orthosis were heat moulded and had medial wedges and/or heel lifts added.

Full-length 3 mm flat EVA inserts, with no inbuilt arch or wedging.

At 6 weeks, the prefabricated foot orthosis produced significant improvements (19.8 mm) on the scale of global improvement compared to the sham orthosis (statistically significant). The foot orthosis provided moderate to marked improvement for 85% of participants compared to 58% for the sham orthosis.

Conrad et al., 1996 [12]

102 participants with rheumatoid arthritis.

Customised orthosis constructed from Rohadur with rearfoot and forefoot posting.

Molded thin leather shell with naugahyde top cover.

At 3 years, the customised and sham foot orthosis provided the same effects on disability and pain measures.

Finestone et al., 1999 [13]

404 participants from military infantry.

Two orthoses: (i) ‘soft’ customised polyurethane orthosis (grade 80 top layer, 60 middle layer, and 80 lower layer), and (ii) ‘semi-rigid’ customised polypropylene orthosis with rearfoot post.

Prefabricated full-length flat insole made of 3 mm polyolefin foam covered with Cambrelle^®.

At 14 weeks, the ‘soft’ (10.7%) and ‘semirigid’ (15.7%) orthoses significantly reduced the incidence of the stress fractures compared to the sham orthosis (27%).

Landorf et al., 2006 [14]

135 participants with plantar fasciitis.

Two orthoses: (i) Customised semirigid polypropylene orthosis with heel post, and (ii) Formthotics^® prefabricated three-quarter length firm density orthosis made from polyethylene foam.

6 mm soft 120 kg/m³ EVA foam moulded to unmodified cast of participant’s foot. No top-cover. EVA shell was ground similarly to other orthoses, including being ground to approximately 1 mm thick under heel.

At 3 months, the customised and prefabricated orthoses produced significant improvements in function (scale, 0–100), 7.5 points & 8.4 points respectively, compared with the sham orthosis (statistically significant). Improvements in pain occurred in both orthotic groups compared with the sham, however these were not significant. At 12 months, no difference in pain and function was observed between orthotic groups.

Milgrom et al., 2005 [15]

404 participants from military infrantry.

Two orthoses: (i) ‘soft’ customised polyurethane orthosis (grade 80 top layer, 60 middle layer, and 80 lower layer), and (ii) ‘semirigid’ customised polypropylene orthosis with rearfoot post.

Prefabricated full-length flat insole made of 3 mm polyolefin foam covered with Cambrelle^®.

At 14 weeks, no differences in subjective or objective measures of back pain were observed between the customised orthosis and sham groups.

Munteanu et al., 2009 [17]

140 participants with Achilles tendinopathy.

Customised orthosis constructed from polypropylene with a rearfoot post and covered with 2 mm Nora^® Lunasoft SL. Polypropylene thickness (3.0 mm, 4.0 mm or 4.5 mm) was determined by body mass and foot posture.

4.0 mm 90 km/m³ EVA with a 2 mm Nora^® Lunasoft SL top cover. Shell was minimally ground under heel.

Study in progress.

Novak et al., 2009 [16]

40 participants with rheumatoid arthritis.

Customised orthosis of three layers: (i) 6 mm cork (ii) 3 mm Plastazote^® and (iii) 2 mm Dynoshaum^®.

‘Unshaped’ insole of three layers: (i) 6 mm cork (ii) 3 mm Plastazote^® and (iii) 2 mm Dynoshaum^®.

No significant difference in pain, activity and plantar pressures was observed between the customised orthosis and sham groups.