Evidence map›Paper›PMID 40495635›Full record

ArticlePain management2025

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

David Hohenschurz-Schmidt, Sasha Smith, Annina B Schmid, Philip Bright, Jerry Draper-Rodi, Matthew C Evans, Harriet Kemp, Nuno Koch Esteves, Elizabeth Pigott, Whitney Scott and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain management, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06423391 (A Multimodal Manual Therapy-Based Intervention for People With Painful Diabetic Neuropathy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06423391 naunknown statusnot on this map

A Multimodal Manual Therapy-Based Intervention for People With Painful Diabetic Neuropathy: Feasibility of a Randomised Controlled Efficacy Trial

TypeinterventionalSponsorUniversity College of OsteopathyRan2024 to 2025Enrolled36ConditionsPainful Diabetic NeuropathyArmsNeuOst, Control Intervention, Usual Care
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

David Hohenschurz-SchmidtImperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.ORCID 0000-0002-1964-6069
Sasha SmithSection of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.ORCID 0000-0001-9843-5368
Annina B SchmidNuffield Department of Clinical Neurosciences, Oxford University, John Radcliffe Hospital, Oxford, UK.ORCID 0000-0001-7759-0211
Philip BrightUCO School of Osteopathy, Health Sciences University, London, UK.ORCID 0000-0002-5339-8281
Jerry Draper-RodiUCO School of Osteopathy, Health Sciences University, London, UK.ORCID 0000-0002-1900-6141
Matthew C EvansDivision of Anaesthetics Pain Medicine & Intensive Care, Imperial College London, London, UK.ORCID 0000-0003-1016-3228
Harriet KempDivision of Anaesthetics Pain Medicine & Intensive Care, Imperial College London, London, UK.ORCID 0000-0001-5657-3009
Nuno Koch EstevesTHERMOSENSELAB, Skin Sensing Research Group, School of Health Sciences, The University of Southampton, Southampton, UK.ORCID 0000-0002-0580-7642
Elizabeth PigottPatient partner, London, UK.
Whitney ScottKing's College London, Health Psychology Section, Institute of Psychiatry, Psychology, and Neuroscience, London, UK.
Jan VollertDepartment of Clinical and Biomedical Sciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.ORCID 0000-0003-0733-5201
Esther WilliamsonNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0003-0638-0406
Esther M Pogatzki-ZahnDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany.ORCID 0000-0003-0981-3940
Steven VogelUCO School of Osteopathy, Health Sciences University, London, UK.ORCID 0000-0002-8597-575X

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundTherapeutic 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

methodsTo 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.

resultsNeuOst (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).

conclusionAfter initial intervention development, a feasibility trial will inform intervention refinement and future research steps. CLINICAL

trial registrationwww.clinicaltrials.gov identifier is NCT06423391.

Indexed as

Diabetic NeuropathiesExercise TherapyMusculoskeletal ManipulationsPain ManagementAdultCombined Modality TherapyFeasibility StudiesFemaleHumansMaleMiddle AgedRandomized Controlled Trials as Topicacceptance and commitment therapymind-body therapyneurodynamic treatmentNeuropathic painosteopathic manipulative treatmentphysical therapy modalitiesPlaceborehabilitation

Identifiers

PMID40495635
PMCPMC12218422

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.