| Methods |
Prospective randomized, single‐blind, sham controlled trial. |
| Participants |
154 adults with chronic foot pain. Pes cavus was defined by a Foot Posture Index score of –2 or less, which is 2 standard deviations below the reported normal mean of +5 (Redmond 2006). |
| Interventions |
Custom‐made foot orthoses versus sham orthoses. |
| Outcomes |
Foot pain, functional limitation, health‐related quality of life, in‐shoe plantar pressure at 3 months. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Using a computer random number generator |
| Allocation concealment? |
Low risk |
Central allocation by telephone by a third party not involved in the study |
| Blinding?
Participant |
Low risk |
Participants were blinded to treatment allocation for the duration of the study |
| Blinding?
Investigator |
High risk |
Blinding of the investigator was not appropriate because of the potential need for ongoing contact with the participants concerning adverse effects |
| Blinding?
Assessor |
Low risk |
No blinding, but primary outcome measure was self‐reported and not likely to be influenced by lack of blinding |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Only one missing outcome data |
| Free of selective reporting? |
Low risk |
Protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way |
| Free of other bias? |
Low risk |
The study appears to be free of other sources of bias. Explicit inclusion criteria, no baseline differences |
