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. 2025 Jul;15(7):387-399.
doi: 10.1080/17581869.2025.2515010. Epub 2025 Jun 11.

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

David Hohenschurz-Schmidt  1 , Sasha Smith  2   3 , Annina B Schmid  4 , Philip Bright  5 , Jerry Draper-Rodi  5   6 , Matthew C Evans  7 , Harriet Kemp  7 , Nuno Koch Esteves  8   9 , Elizabeth Pigott  10 , Whitney Scott  11   12 , Jan Vollert  13 , Esther Williamson  14   15 , Esther M Pogatzki-Zahn  16 , Steven Vogel  5
Affiliations

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

David Hohenschurz-Schmidt et al. Pain Manag. 2025 Jul.

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.

Keywords: Neuropathic pain; Placebo; acceptance and commitment therapy; mind-body therapy; neurodynamic treatment; osteopathic manipulative treatment; physical therapy modalities; rehabilitation.

Plain language summary

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 onlyWe 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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Conflict of interest statement

The study was conducted with the approval of the sponsor’s institutional research ethics committee (Health Sciences University, UCO School of Osteopathy), with approval granted on 5 April 2024 (No identification numbers used by this committee). The consent process consists of verbal consent for telephone screening and full written consent for trial participation before the baseline assessment. Upon review of the Participant Information Sheet (PIS, Supplementary Material 6), signed consent is collected via post or in person (Supplementary Material 7). Capacity to consent is assessed through discussion and, if necessary, a validated questionnaire [48].

Figures

Figure 1.
Figure 1.
Process flowchart of intervention development and feasibility evaluation. Adapted from: Craig P, Campbell M. Evaluability assessment: a systematic approach to deciding whether and how to evaluate programmes and policies: a what works Scotland working paper. 2015. adapted from [30].
Figure 2.
Figure 2.
NeuOst logic model, describing the intervention context, rationale, key resources, intervention components, target outcomes and mechanisms, and hypothesized wider impacts. ACT, acceptance and commitment therapy; MSK, musculoskeletal. Created based on available guidance for the development of logic models for complex interventions: https://www.Gov.uk/guidance/evaluation-in-health-and-wellbeing-creating-a-logic-model & https://www.strategyunitwm.nhs.uk/sites/default/files/2018-03/Logic%20models%20%20complex%20programmes%20-%20a%20brief%20guide.pdf [41].
Figure 3.
Figure 3.
Flow diagram of the NeuOst feasibility trial. Interventions are described in detail in the manuscript text and appendices, with ‘control intervention’ referring to a specifically designed intervention replicating the tested (‘NeuOst’) intervention but omitting components the effects of which are to be studied in the trial. All three trial groups continue their usual care outside the trial. BL, baseline assessment; F-U, follow-up assessment; R, randomization; UC, usual care.
See this image and copyright information in PMC

References

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