Hohenschurz-Schmidt David, Smith Sasha, Schmid Annina B, Bright Philip, Draper-Rodi Jerry, Evans Matthew C, Kemp Harriet, Esteves Nuno Koch, Pigott Elizabeth, Scott Whitney, Vollert Jan, Williamson Esther, Pogatzki-Zahn Esther M, Vogel Steven
Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Pain Manag. 2025 Jul;15(7):387-399. doi: 10.1080/17581869.2025.2515010. Epub 2025 Jun 11.
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.
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.
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).
After initial intervention development, a feasibility trial will inform intervention refinement and future research steps.
www.clinicaltrials.gov identifier is NCT06423391.
糖尿病周围神经病变所致神经性疼痛患者的治疗选择有限，且影响可能很严重。物理和心理干预仍未得到充分探索，但可能带来希望，尤其是在多模式联合方案中。
为填补这一空白，根据医学研究理事会的复杂干预框架开发了一种干预措施，包括研究专家和利益相关者的意见。这将在一项试验中测试其可接受性和可行性。
NeuOst（通过自我管理和治疗优化神经病变）是一种基于手法治疗的干预措施，包括运动、心理指导训练和教育。本文介绍了一项单中心、平行、三臂、部分参与者设盲的随机对照试验方案。实验性治疗是为期5周的NeuOst课程，作为患者常规护理的辅助。对照组是一种缺乏感兴趣的预先指定成分的对照干预措施，作为常规护理的辅助，以及仅对患有疼痛性糖尿病周围神经病变的成年人进行常规护理。随访期为16周。主要结局是可行性指标，如招募、合格性和同意率、保留率、设盲、保真度、可接受性和安全性。次要和探索性结局包括临床指标和定性反馈。该方案已进行前瞻性注册（NCT06423391）。
在初步开发干预措施后，一项可行性试验将为干预措施的完善和未来的研究步骤提供信息。
