Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423391
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-09
Brief Title:
Multimodal Intervention for Painful Diabetic Neuropathy NeuOst Feasibility Trial
Sponsor:
University College of Osteopathy
Organization:
University College of Osteopathy
Study Overview
Official Title:
A Multimodal Manual Therapy-Based Intervention for People With Painful Diabetic Neuropathy Feasibility of a Randomised Controlled Efficacy Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeuOst
Brief 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 111 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 TSCDMC 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
Blocked randomisation will allocate participants in a 111 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 TSCDMC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None