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

Journal: Pain Management Date: 2025/07, 15(7):Pages: 387-399. doi: Subito , type of study: randomized controlled trial

Free full text   (https://www.tandfonline.com/doi/full/10.1080/17581869.2025.2515010)

Keywords:

diabetes [51]
neuropathy [18]
OMT [3800]
osteopathic manipulative treatment [3821]
randomized controlled trial [906]
study protocol [1]

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. People with diabetes can develop nerve pain in their feet, which can greatly affect quality of life. Current treatments are limited. Physical and psychological approaches – like exercise, massage, and supportive conversations – may help but are rarely combined or fully tested. We have developed a new treatment program called NeuOst, which brings together hands-on therapy, exercise, and conversations for pain management. It was designed with people with lived experience, healthcare professionals, and researchers. We are now running a small study to test whether this program is practical to deliver and acceptable to participants. Adults with painful diabetic neuropathy are randomly placed into one of three groups (in addition to their normal care outside the study): NeuOst (5 sessions) A comparison treatment (similar to NeuOst but with some elements removed; 5 sessions) Usual care only. We follow participants for 16 weeks and look at how the program was delivered, how people experienced it, and any early signs of benefit.The results will guide improvements to the treatment and inform future research.


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