A multimodal intervention of manual therapy, exercise, and psychological management for painful diabetic neuropathy: intervention development and feasibility trial protocol.

Abstract

Background: Therapeutic options for people experiencing neuropathic pain from diabetic peripheral neuropathy are limited, and impact can be severe. Physical and psychological interventions remain under-explored but may offer promise, especially in multimodal combination programs.

Objectives and methods: To address this gap, an intervention was developed according to the Medical Research Council's framework for complex interventions, including research expert and stakeholder input. This will be tested for acceptability and feasibility in a trial.

Results: NeuOst (Neuropathy Optimisation through Self-management and Therapy) is a manual therapy-based intervention, incorporating exercise, psychologically informed training, and education. The protocol for a single-site, parallel, three-arm, partially participant-blinded, randomized controlled trial is presented. The experimental treatment is a 5-week course of NeuOst as adjunct to patients' usual care. Comparators are a control intervention that lacks pre-specified components of interest as adjunct to usual care and usual care only in adults with painful diabetic peripheral neuropathy. The follow-up period is 16 weeks. Primary outcomes are feasibility measures such as recruitment, eligibility, and consent rates, retention, blinding, fidelity, acceptability, and safety. Secondary and exploratory outcomes involve clinical measures and qualitative feedback. A protocol was prospectively registered (NCT06423391).

Conclusion: After initial intervention development, a feasibility trial will inform intervention refinement and future research steps.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT06423391.