The Effect of Short and Long-Term Therapeutic Treatment with Insoles and Shoes on Pain, Function, and Plantar Load Parameters of Women with Plantar Fasciitis: A Randomized Controlled Trial

Background and Objectives: Plantar fasciitis (PF) is a prevalent musculoskeletal disease, with inflammation at the origin of the plantar fascia, that affects sedentary people, particularly middle-aged women. Foot pain and functional limitations lead patients to seek treatment. Investigate the therapeutic effect of conservative treatment combining a custom insole with minimalist flexible shoes and the shoes alone in a gait-training protocol, in the short and long term, in women with PF. Materials and Methods: Design: A randomized, controlled, and single-blind trial. Setting: Biomechanics laboratory. Participants: 36 women, 26 with acute PF and 10 controls. Intervention: Gait-training protocol wearing the minimalist shoes alone (SG, n = 12, age: 46.4 +/- 9.6, height: 1.60 +/- 0.2, BMI: 28.8 +/- 4.2), with a custom insole in the shoes (CIG, n = 14, age: 48.9 +/- 9.8, height: 1.60 +/- 0.1, BMI: 26.7 +/- 5.6), and control (CG, n = 10, age: 46.1 +/- 10.7, height: 1.61 +/- 0.2, BMI: 26.4 +/- 4.8). Evaluations were performed at baseline (T0) and after three (T3) and six (T6) months. The intervention had a duration of six months (six hours a day, seven days a week). Primary outcomes were rearfoot pain (visual analogue scale), the Foot Function Index (FFI), Foot Health Status Questionnaire (FHSQ-Br), and 6 min walk test (6MWT). The secondary outcomes were plantar pressure distribution during gait, measured by the pressure platform, and foot posture. Results: The CIG was effective for reducing pain and improving the FPI after T6 compared to CG. The FPI, FHSQ-Br and 6MWT demonstrated improvements after T6 in both the CIG and SG, compared to the CG. After T6, contact area (rearfoot) and maximum force (forefoot) reduced with CIG. Maximum force (midfoot and rearfoot) reduced with CIG and SG, as did peak pressure (forefoot and midfoot) in relation to CG. Conclusions: A customized insole associated with minimalist flexible shoes during a gait-training protocol can be recommended as a more effective treatment than minimalist flexible shoes alone over the short and long term, for reduction in calcaneus pain, increased function and foot health, and improved walking through reduced plantar load in women with PF.