Comparison of Structural Diagnosis and Management (SDM) Approach versus Myofascial Release (MFR) for Plantar Heel Pain in People with Diabetes Mellitus: A Study Protocol for a Multicentre Randomised Clinical Trial

IntroductionPlantar heel pain (PHP) is a common musculoskeletal condition among individuals with diabetes mellitus (DM), often linked to plantar fasciitis, heel spurs, and myofascial dysfunction. It leads to chronic pain, limited mobility, and reduced quality of life. Although manual therapy is effective in non-diabetic populations, there is limited evidence supporting its use in diabetic patients. This multicentre randomised clinical trial aims to compare the effectiveness of Structural Diagnosis and Management (SDM) versus Myofascial Release (MFR) in managing PHP in people with diabetes mellitus, with a focus on reducing pain and improving function and disability outcomes to address a critical clinical and research gap. Methods and analysisThis 8-week, parallel-group, assessor- and participant-blinded, two-arm randomised clinical trial will include 90 diabetic participants aged 30-65 years with PHP, recruited from three diabetic hospitals in Bangladesh. Participants will be randomly assigned (1:1) to receive either the SDM or MFR therapeutic approach, with 24 sessions over 8 weeks (each lasting 45-60 minutes). The primary outcome will be pain intensity, measured using a 10 cm Visual Analogue Scale (VAS). Secondary outcomes will include ankle range of motion, muscle strength, and the Foot Function Index (FFI). Assessments will be conducted at baseline, posttest (8 weeks), and follow-up (20 weeks) to evaluate both immediate and long-term effects. Ethics and disseminationThe study received ethical approval from the Institutional Review Board of the Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (Approval ID: PTRJUST/IRB/2025/03/192411). All activities and exercise programs will be conducted following the 2020 Helsinki Declaration. Findings will be shared through professional conferences and in an international, Scopus-indexed, peer-reviewed journal to inform clinical guidelines for PHP management in individuals with diabetes mellitus. Trial registration numberThe Trial was Registered Prospectively. Trial number was CTRI/2024/11/076311 [Registered on: 05/11/2024] What is already known on this topic?Plantar heel pain is common among people with diabetes mellitus, causing pain, limited mobility, muscle weakness, and reduced function. Although various treatments are available, many lack long-term effectiveness and value for money. SDM and MFR are specific, evidence-based physiotherapy methods; however, there is limited comparative evidence on their efficacy in this population. What this study adds?This study presents a direct comparison between the SDM and MFR approaches in managing plantar heel pain in individuals with diabetes mellitus. It will assess key clinical outcomes--pain intensity, ankle range of motion, muscle strength, disability, and activity limitation--over an 8-week intervention period, followed by a 12-week follow-up. The study aims to establish evidence for a more effective and sustainable physiotherapy intervention, thereby improving treatment protocols in this population. How this study might affect research, practice or policies?By determining the most effective intervention between SDM and MFR, this study will promote evidence-based physiotherapy practices for managing plantar heel pain in diabetic patients. The findings may inform clinical decision-making, contribute to the development of cost-effective, non-pharmacological treatment guidelines, and influence future research directions and rehabilitation policies in diabetic foot care.