J Am Podiatr Med Assoc. 2024 May-Jun;114(3). doi: 10.7547/22-091.
Foot pain is a common presentation, and management is generally geared toward pressure offloading. Although several pressure offloading devices exist on the market, the search for the optimal device is ongoing.
We recently developed PopSole, an inexpensive, simple, balanced offloading insole focused on reducing targeted foot pain. We conducted a prospective validation study of patients with foot pain lasting longer than 6 months to assess the durability and efficacy of the device with follow-up scheduled at 2 weeks, 4 weeks, 2 months, and 3 months. Patient-reported outcomes were collected using multiple validated surveys. Fifteen patients were enrolled in this study.
At 4 weeks, pain, function, and quality of life across all surveys showed statistically significant improvement. For the 6 patients with long-term outcomes (3 months), patients reported improvement in their pain, function, and quality of life across all surveys, which were significant in the Mayo survey (P = .018), the Manchester Foot Pain and Disability Index (P = .014), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale (P = .032), the Foot and Ankle Ability Measure activities of daily living (P = .009), and the Pittsburgh foot survey (P = .01); the Foot and Ankle Ability Measure sports approached statistical significance (P = .058).
The PopSole is a durable and effective device to relieve foot pain, improve function, and improve quality of life for up to 3 months of use.
足部疼痛是一种常见的症状，其治疗通常侧重于减轻压力。尽管市场上存在几种减压设备，但仍在不断寻找最佳的设备。
我们最近开发了 PopSole，这是一种价格低廉、简单、平衡的减压鞋垫，专注于减轻特定足部疼痛。我们对足部疼痛持续超过 6 个月的患者进行了前瞻性验证研究，以评估该设备的耐用性和疗效，并计划在 2 周、4 周、2 个月和 3 个月进行随访。使用多个经过验证的调查收集患者报告的结果。本研究共纳入 15 名患者。
在第 4 周时，所有调查的疼痛、功能和生活质量均显示出统计学上的显著改善。对于长期结果（3 个月）的 6 名患者，患者报告在所有调查中疼痛、功能和生活质量均得到改善，Mayo 调查（P =.018）、曼彻斯特足部疼痛和残疾指数（P =.014）、美国矫形足踝协会踝后足量表（P =.032）、足踝能力测量日常生活活动（P =.009）和匹兹堡足部调查（P =.01）均有显著改善，足踝能力测量运动也接近统计学意义（P =.058）。
PopSole 是一种耐用且有效的缓解足部疼痛、改善功能和提高生活质量的设备，最长可持续使用 3 个月。
