A multimodal manual therapy, exercise, and psychological intervention for painful diabetic neuropathy: The NeuOst feasibility randomised controlled trial
File(s)
Accepted version
Author(s)
Hohenschurz-Schmidt, David
Type
Journal Article
Abstract
Background
People with painful diabetic neuropathy lack effective and tolerable treatments.
Physical and psychological interventions may help but require further study and
combination to maximise effects.
Objective
This single-site, three-arm, parallel, randomised feasibility trial tested whether a
multimodal intervention combining manual therapy, exercise, and psychologically
informed conversations (‘NeuOst’) was feasible, and a full-scale trial possible.
Methods
Adults with painful diabetic neuropathy were randomised 1:1:1 to either 1) five individual sessions of NeuOst, 2) five sessions of a high-similarity control intervention
with the same osteopaths, or 3) usual care. Allocation was computer-generated, and
blinding intended for assessors, research and administrative staff, and participants
receiving NeuOst or the high-similarity control intervention. Feasibility and acceptability
were assessed using predefined criteria. Exploratory clinical outcomes included pain,
disability, and quality of life, collected up to 16 weeks post-randomisation.
Results
Thirty-six participants were randomised; targets were met for eligibility (64%), consent
(88%), retention (89%), blinding, fidelity, data completeness, and acceptability. Mean
NeuOst session attendance was 82% and satisfaction high (mean 4.8/5). No serious
adverse reactions occurred. Minor adverse responses were reported by 25% of
NeuOst and 42% of control intervention participants. Recruitment rates indicated that
modified procedures would be needed for a larger trial. Clinical outcomes were
uncertain compared to control and promising compared to usual care.
Conclusion
The NeuOst intervention was safe, acceptable, and feasible. The trial design proved
largely workable, with areas for refinement identified. Findings support progression to
an effectiveness trial.
Registration: NCT06423391/https://osf.io/jyftb
Funding: Alan & Sheila Diamond Charitable Trust, The Osteopathic Foundation
People with painful diabetic neuropathy lack effective and tolerable treatments.
Physical and psychological interventions may help but require further study and
combination to maximise effects.
Objective
This single-site, three-arm, parallel, randomised feasibility trial tested whether a
multimodal intervention combining manual therapy, exercise, and psychologically
informed conversations (‘NeuOst’) was feasible, and a full-scale trial possible.
Methods
Adults with painful diabetic neuropathy were randomised 1:1:1 to either 1) five individual sessions of NeuOst, 2) five sessions of a high-similarity control intervention
with the same osteopaths, or 3) usual care. Allocation was computer-generated, and
blinding intended for assessors, research and administrative staff, and participants
receiving NeuOst or the high-similarity control intervention. Feasibility and acceptability
were assessed using predefined criteria. Exploratory clinical outcomes included pain,
disability, and quality of life, collected up to 16 weeks post-randomisation.
Results
Thirty-six participants were randomised; targets were met for eligibility (64%), consent
(88%), retention (89%), blinding, fidelity, data completeness, and acceptability. Mean
NeuOst session attendance was 82% and satisfaction high (mean 4.8/5). No serious
adverse reactions occurred. Minor adverse responses were reported by 25% of
NeuOst and 42% of control intervention participants. Recruitment rates indicated that
modified procedures would be needed for a larger trial. Clinical outcomes were
uncertain compared to control and promising compared to usual care.
Conclusion
The NeuOst intervention was safe, acceptable, and feasible. The trial design proved
largely workable, with areas for refinement identified. Findings support progression to
an effectiveness trial.
Registration: NCT06423391/https://osf.io/jyftb
Funding: Alan & Sheila Diamond Charitable Trust, The Osteopathic Foundation
Date Acceptance
2026-07-24
Citation
PAIN Reports
ISSN
2471-2531
Publisher
Wolters Kluwer
Journal / Book Title
PAIN Reports
Copyright Statement
Copyright This paper is embargoed until publication. Once published the Version of Record (VoR) will be available on immediate open access.
License URL
Publication Status
Accepted