Comparison of Structural Diagnosis and Management Approach Versus Myofascial Release for Plantar Heel Pain in People With Diabetes Mellitus: A Multicenter Randomized Clinical Trial Protocol

Background and Aims: Plantar heel pain (PHP) is prevalent among individuals with diabetes mellitus and contributes to chronic pain, reduced mobility, muscle weakness, and activity limitation. Conventional treatments such as medications and physical modalities are used but often lack long-term effectiveness and cost-efficiency. Physiotherapy approaches, including Structural Diagnosis and Management (SDM) and Myofascial Release (MFR), have demonstrated benefits; however, comparative evidence in diabetic populations is limited. This study aimed to evaluate and compare the effectiveness of SDM and MFR in reducing pain and disability and improving function in people with diabetes mellitus experiencing PHP. Methods: This study was a multicenter, assessor- and participant-blinded randomized clinical trial. A total of 90 participants with diabetes mellitus, aged 30-65 years, and diagnosed with PHP were recruited from 3 diabetic hospitals in Bangladesh. Participants were randomly allocated (1:1) to the SDM group or the MFR group. Intervention was delivered over 8 weeks, comprising 24 sessions of 45-60 min each. The primary outcome, pain intensity, assessing by Visual Analog Scale (VAS). Secondary outcomes include ankle range of motion, muscle strength, and the Foot Function Index (FFI). The study adhered to CONSORT guidelines, and data analyze in SPSS using the intention-to-treat principle. Results: All primary and secondary outcomes were planned to assess at baseline, postintervention (8 weeks), and follow-up (20 weeks) to examine both immediate and sustained effects of the interventions, with comparative analyses evaluating the effectiveness of SDM versus MFR in individuals with diabetes mellitus and PHP. Conclusions: This trial will provide the first direct comparison of SDM and MFR for the management of PHP in individuals with diabetes mellitus. The findings are expected to support evidence-based, cost-effective, nonpharmacological physiotherapy interventions and may inform future research and rehabilitation policies in diabetic foot care. Trial Registration: CTRI/2024/11/076311.