Validation and Utility of a Novel Foot Offloading Device: Improving Pain and Function

Area of Science:

• Orthopedics
• Biomechanical Engineering
• Podiatry

Background:

• Foot pain is a prevalent condition requiring effective pressure offloading solutions.
• Current pressure offloading devices are continuously being evaluated for optimal performance.
• The development of innovative and accessible foot pain management tools remains an active area of research.

Purpose of the Study:

• To validate the durability and efficacy of the novel PopSole insole.
• To assess the impact of the PopSole on patient-reported outcomes for targeted foot pain.
• To evaluate the PopSole's effectiveness in improving pain, function, and quality of life.

Main Methods:

• A prospective validation study was conducted on fifteen patients with chronic foot pain (duration > 6 months).
• The PopSole, an inexpensive and balanced offloading insole, was utilized for pain management.
• Patient-reported outcomes were collected using validated surveys at multiple follow-up points (2 weeks to 3 months).

Main Results:

• Statistically significant improvements in pain, function, and quality of life were observed at 4 weeks.
• Long-term outcomes (3 months) in six patients demonstrated sustained improvements across multiple validated surveys.
• Specific significant improvements were noted in the Mayo survey, Manchester Foot Pain and Disability Index, AOFAS ankle-hindfoot scale, FAAM ADL, and Pittsburgh foot survey.

Conclusions:

• The PopSole insole is a durable and effective intervention for relieving foot pain.
• The device demonstrates significant improvements in patient function and quality of life.
• PopSole offers a valuable, accessible option for managing chronic foot pain for up to three months.