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

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.