A multimodal manual therapy, exercise, and psychological intervention for painful diabetic neuropathy: the NeuOst feasibility randomised controlled trial.

Abstract

Introduction: People with painful diabetic neuropathy lack effective and tolerable treatments. Physical and psychological interventions may help but require further study and combination to maximise effects. Objectives: This single-site, 3-arm, parallel, randomised feasibility trial tested whether a multimodal intervention combining manual therapy, exercise, and psychologically informed conversations ("NeuOst") was feasible, and a full-scale trial possible. Methods: Adults with painful diabetic neuropathy were randomised 1:1:1 to either (1) 5 individual sessions of NeuOst, (2) 5 sessions of a high-similarity control intervention with the same osteopaths, or (3) usual care. Allocation was computer-generated, and blinding was intended for assessors, research and administrative staff, and participants receiving NeuOst or the high-similarity control intervention. Feasibility and acceptability were assessed using predefined criteria. Exploratory clinical outcomes included pain, disability, and quality of life, collected up to 16 weeks post-randomisation. Results: Thirty-six participants were randomised; targets were met for eligibility (64%), consent (88%), retention (89%), blinding, fidelity, data completeness, and acceptability. Mean NeuOst session attendance was 82%, and satisfaction was high (mean 4.8/5). No serious adverse reactions occurred. Minor adverse responses were reported by 25% of NeuOst and 42% of control intervention participants. Recruitment rates indicated that modified procedures would be needed for a larger trial. Clinical outcomes were uncertain compared with control and promising compared with usual care. Conclusion: The NeuOst intervention was safe, acceptable, and feasible. The trial design proved largely workable, with areas for refinement identified. Findings support progression to an effectiveness trial.