Multimodal Intervention for Painful Diabetic Neuropathy: NeuOst Feasibility Trial

NCT06423391 | Active Not Recruiting DMC

• 1 other identifier: NeuOst feasib V 1.0 March 2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

  Using pre-defined set of feasibility criteria, measuring recruitment, consent rates, treatment completion, retention rates, interventionist fidelity in treatment delivery, treatment acceptability, blinding success, data completeness, adverse events, and participant acceptability.

  12 months from recruitment start

Secondary Outcomes (4)

• Pain intensity (average in past week)

  1, 2, 3, 4, 5, 8, 16 weeks

• Impact of Diabetic Neuropathic Pain

  5, 8, 16 weeks

• Neuropathy- and Foot Ulcer-Specific Quality of Life

  5, 8, 16 weeks

• Fear of Falling

  5, 8, 16 weeks

Other Outcomes (5)

• Global Impression of Change

  5, 8, 16 weeks

• Concomitant medication and intervention use

  5, 8, 16 weeks

• Pain Bothersomeness

  1, 2, 3, 4, 5, 8, 16 weeks

Study Arms (3)

Tested intervention (NeuOst treatment)

EXPERIMENTAL

The tested treatment is a manual therapy-based intervention, drawing on core manual therapy components and integrating psychologically informed approaches to pain management and elements from diabetes education, foot care, and exercise rehabilitation. This intervention is called 'Augmented manual therapy for people with painful diabetic neuropathy', or NeuOst. NeuOst components will be taught to fully qualified UK-registered osteopaths who then deliver the intervention according to a treatment manual in 1:1 appointments, lasting 45-60 minutes each (90 mins first appointment). Up to 5 treatment sessions will be provided per patient, at weekly intervals and at maximum over 10n weeks. The treatment manual specifies obligatory and optional elements for each of the 5 study treatment sessions. Exercise components will be rehearsed in the clinic with providers. Participants will then be encouraged to complete a progressive home-exercise programme according to the manual.

Other: NeuOst

Control intervention

SHAM COMPARATOR

The objectives of the control intervention are to replicate the contextual elements of the test intervention (to test efficacy), and to blind participants to group allocation. Trial providers will be trained in its delivery. As per CoPPS guidance, the control intervention will resemble the tested intervention in all aspects but for the components whose effect the trial is designed to study. These excluded components of interest, and their respective adaptations in the control intervention, are specified in the detailed pre-registered protocol. Control intervention components will be taught to fully qualified UK-registered osteopaths who then deliver the intervention according to a treatment manual in 1:1 appointments, lasting 45-60 minutes each (90 mins first appointment). Up to 5 treatment sessions will be provided per patient, at weekly intervals and at maximum over 10 weeks.

Other: Control Intervention

Usual care comparator

OTHER

Participants randomized to this study arm will only undergo baseline and follow-up assessments but will receive no further attention as part of this trial. As in all other trial arms, they are free to continue their usual medical care but will be encouraged to not change their analgesic regime or nonpharmacological management as far as possible.

Other: Usual Care

Interventions

NeuOst OTHER

As above

Tested intervention (NeuOst treatment)

Control Intervention OTHER

As above

Control intervention

Usual Care OTHER

As above

Also known as: Treatment as Usual

Usual care comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical diagnosis of diabetes mellitus (type 1 or type 2) as per patient self-report.
• Distal symmetrical peripheral neuropathy (defined as a score of ≥4 on the Michigan Neuropathy Screening Instrument (questionnaire part) (Herman et al., 2012)).
• Neuropathic pain as assessed by DN4 questionnaire (defined as a score of ≥3 of 7 self-reported items) (Spallone et al., 2012).
• Stable analgesic medication regimen for at least 3 weeks prior to anticipated study enrolment and no revision of regimen planned within the next 3 months.
• Stable attendance of out-of-study nonpharmacological therapies for neuropathic pain or professional exercise programmes (including gym classes and manual therapy) for at least 3 weeks prior to anticipated study enrolment and no revision of routine planned within the next 3 months.
• Participants capable of giving informed consent themselves.
• Participants able to speak, understand, and read English at conversational levels.
• Age: 18 and older.

You may not qualify if:

• Contraindications to manual therapy and conservative pain management (as determined by recruiting staff during screening calls or the trial provider at the initial or any other appointment; May include medical emergencies and suspected severe pathology, advanced osteoporosis, and active foot ulcerations)
• Past or scheduled amputations
• Advanced renal failure
• Recent physical trauma and suspected fracture
• Currently experiencing severe depressive or other current and severe psychopathology such as bipolar/psychosis, and/or presenting with active suicidal risk
• Carpal Tunnel Syndrome diagnosis or symptoms as the only source of neuropathic pain
• Unable or unwilling to provide consent for study participation
• Unable to attend in-person appointments at treatment site (for health reasons)
• Unable to attend in-person appointments at treatment site (for organisational reasons)
• Knowing other participants signed up to the study (to avoid group contamination)
• Concomitant participation in another clinical intervention study
• Changes in medication or physical activity programmes in the past 1 month or planned for the next 3 months.

Sponsors & Collaborators

• University College of Osteopathy: lead
• Imperial College London: collaborator
• King's College London: collaborator
• University of Oxford: collaborator
• Universität Münster: collaborator

Study Sites (1)

University College of Osteopathy

London, SE1 1HX, United Kingdom

Location

Related Publications (1)

• Hohenschurz-Schmidt D, Smith S, Schmid AB, Bright P, Draper-Rodi J, Evans MC, Kemp H, Esteves NK, Pigott E, Scott W, Vollert J, Williamson E, Pogatzki-Zahn EM, Vogel S. A multimodal intervention of manual therapy, exercise, and psychological management for painful diabetic neuropathy: intervention development and feasibility trial protocol. Pain Manag. 2025 Jul;15(7):387-399. doi: 10.1080/17581869.2025.2515010. Epub 2025 Jun 11.

  PMID: 40495635 DERIVED

Related Links

• Full protocol (embargoed until Nov 2024)
• Study website

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• David Hohenschurz-Schmidt, PhD

  University College of Osteopathy / Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The following stakeholders will be blinded to participants' group allocation in the test intervention and control intervention groups. Allocation to the Usual Care group will not be concealed from staff or participants, except for the trial statistician: * Trial participants (except in usual care arm) * Clinical support and administration staff * Outcome assessors (collecting data at end-of-treatment and follow-up) * Trial statistician * Provider blinding will not be possible as providers will have to actively deliver both the test and the control intervention. However, extensive pre-trial training and supervision during the trial will ensure that providers understand the purpose of the control intervention and are supported to deliver it with high fidelity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: feasibility study of a single-site parallel three-armed participant-blinded controlled randomised trial

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 21, 2024
• Study Start: April 30, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 15, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Once the final report of all analyses specified in this report has been published in a scientific journal.
• Access Criteria: Anyone can access

Locations

GB (1)