Custom insoles versus sham and GP-led usual care in patients with plantar heel pain: results of the STAP study – a randomized controlled trial
Existing studies provide conflicting evidence in the effectiveness of orthosis for plantar heel pain which is a common cause of foot pain. Nadine Rasenberg and colleagues have conducted a randomized clinical trial, namely “Custom insoles versus sham and GP-led usual care in patients with plantar heel pain: results of the STAP study – a randomized controlled trial“, to study the effectiveness of three treatments for plantar heel pain i.e. custom-made insole, sham insole, and usual care provided by GP. A summary of their findings have been given below:
Objectives:
To compare the outcome of custom made insoles, sham insoles and GP led usual care in patients with plantar heel pain.
Method:
Eligibility Criteria- 18-65years of age, diagnosed with plantar heel pain for a minimum of 2 weeks and no longer than 2 years.
Subjects were divided into three groups:
i. GP led treatment
ii. Referred to the podiatrist for custom made insole treatment
iii. Referred to the podiatrist for sham insole treatment
Every patient was provided with an information booklet and exercise
Findings:
The study concludes no comparative difference between three treatments, indicating that GP led usual care, custom made insole, and sham insole shows a similar outcome. Also, no treatment between three is superior to the other. The study reports that increased GP visits by patients and the use of freely available corticosteroid injections as well as a biochemical intervention might have affected the similarity in results. Improvement in pain at rest was observed. This was a primary outcome as pain at rest is most burdensome in these patient. Authors advice to include the importance of usual care during counseling as it is not the same as doing nothing.
Limitation:
As this was the first study mentioning usual GP care as a treatment arm, the authors acknowledge that there is a need for more studies with a similar design.
