NCT06423391

Multimodal Intervention for Painful Diabetic Neuropathy: NeuOst Feasibility Trial

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University College of Osteopathy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is the feasibility study of a single-site parallel three-armed participant-blinded controlled randomised efficacy trial of a 5-week course of the 'NeuOst treatment', compared to a designated control intervention, and to usual care only, for adults with pDPN.

Detailed description

Eligible participants are adults diagnosed with diabetes and pDPN, as evaluated with clinical questionnaires during an initial telephone screening. Participants with foot ulcerations, amputations, and advanced organ failure are excluded. Twelve participants per arm (36 in total) will be recruited via social media, local print media, and a poster and leaflet campaign in relevant clinics. Blocked randomisation will allocate participants in a 1:1:1 ratio, using permuted block sizes. The test intervention consists of five weekly 1-hour sessions of semi-standardised augmented manual therapy with a specifically trained provider (NeuOst), in addition to participants' continued usual care. The control intervention will be specifically matched following current guidance, replicating the NeuOst intervention in all aspects except selected components which the study aims to investigate. Providers will be UK-registered osteopaths. Both test and control intervention were developed with extensive involvement of people with pDPN and practitioners. The third study arm will be a Usual Care (UC) group, consisting of baseline and follow-up assessments only. All trial participants can continue their usual care outside the trial, although participants will be asked to not alter their medication regimens or nonpharmacological management if possible. An independent combined steering \& data-monitoring committee (TSC/DMC) will monitor the trial throughout and include a stakeholder representative. Participants will be reimbursed for their travel expenses but not time. Screening and follow-up data collection will be conducted electronically or via the phone to minimise trial burden. The timepoints of follow-up are immediately after treatment completion, and at 8 and 16 weeks from randomisation. Key methodological and reporting guidance for feasibility trials will be followed, and a protocol pre-registered. Ethical approval was obtained from the institutional Research Ethics Committee. Feasibility of a definite trial will be judged according to pre-specified criteria regarding the primary feasibility outcomes following pre-specified progression rules: Recruitment, consent rates, treatment completion, retention rates, interventionist fidelity in treatment delivery, data completeness, treatment acceptability, blinding success, and adverse events. Secondary outcomes include measures of pain intensity, interference, and quality, sleep, quality of life, and fear of falling. The sample size of 36 was a pragmatic decision based on available funding and the trial is not powered to detect meaningful differences in clinical outcomes. Analysis of feasibility outcomes will be largely descriptive. For clinical outcomes, a pre-specified blinded analysis will provide estimates of changes in clinical outcome measures and their variance, modelling differently sized confidence intervals and presenting them as forest plot with the MCID indicated. This information can then be used for sample size calculations for a potential full-scale trial. Qualitative data from interviews with volunteering participants and trial interventionists will provide further nuance for progression decisions or intervention refinement.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
OTHER	NeuOst	As above
OTHER	Control Intervention	As above
OTHER	Usual Care	As above

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-05-01
• Completion: 2025-06-15
• First posted: 2024-05-21
• Last updated: 2025-02-27

Locations

1 site across 1 country: United Kingdom