Painful Diabetic NeuropathyNeuOstNCT06423391
Multimodal Intervention for Painful Diabetic Neuropathy: NeuOst Feasibility Trial
A study testing NeuOst in people with Painful Diabetic Neuropathy, run by University College of Osteopathy at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- NeuOst
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multimodal Manual Therapy-Based Intervention for People With Painful Diabetic Neuropathy: Feasibility of a Randomised Controlled Efficacy Trial
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.
Read the 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
- Being tested
- NeuOst, Control Intervention, Usual Care
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuOstOther
As above
Control InterventionOther
As above
Usual CareOther
Also called Treatment as Usual
As above
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from recruitment start
Secondary outcomes (4)
Pain intensity (average in past week)
measured on the Brief Pain Inventory (Short Form)
Measured: 1, 2, 3, 4, 5, 8, 16 weeks
Impact of Diabetic Neuropathic Pain
measured on the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure
Measured: 5, 8, 16 weeks
Neuropathy- and Foot Ulcer-Specific Quality of Life
Neuropathy- and foot ulcer-specific quality of life instrument (NeuroQoL)
Measured: 5, 8, 16 weeks
Fear of Falling
Falls Efficacy Scale (FES-I, short form)
Measured: 5, 8, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start30 Apr 2024
- Primary completion1 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- feasibility study of a single-site parallel three-armed participant-blinded controlled randomised trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Osteopathy
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, King's College London, University of Oxford, Universität Münster
- Responsible party
- Sponsor
- Investigators
- David Hohenschurz-Schmidt, PhD, Principal investigator, University College of Osteopathy / Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423391
- Sponsor's protocol ID
- NeuOst feasib V 1.0 March 2024
- Acronym
- NeuOst
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sharing of trial data, specifically anonymised individual patient data and summary data, is permissible once the final report of all analyses specified in this report has been published in a scientific journal. External parties can request access to this dataset or the dataset may be shared on an online repository (OSF.io).
Publications
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.
PubMed 40495635
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Manual Therapy-Based Intervention for People With Painful Diabetic Neuropathy: Feasibility of a Randomised Controlled Efficacy Trial
- ClinicalTrials.gov ID
- NCT06423391
- Acronym / sponsor ID
- NeuOst / NeuOst feasib V 1.0 March 2024
- Conditions
- Painful Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University College of OsteopathyUniversity, hospital or other
- Collaborators
- Imperial College London, King's College London, University of Oxford, Universität Münster
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- feasibility study of a single-site parallel three-armed participant-blinded controlled randomised trial
| Arm | Type | Receives |
|---|---|---|
| Tested intervention (NeuOst treatment) | Experimental | Other: NeuOstThe 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. |
| Control intervention | Sham comparator | Other: Control InterventionThe 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. |
| Usual care comparator | Other | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuOstAs above | Other | Tested intervention (NeuOst treatment) |
| Control InterventionAs above | Other | Control intervention |
| Usual CareAlso: Treatment as UsualAs above | Other | Usual care comparator |
Primary outcome
Study Feasibility
Time frame: 12 months from recruitment start
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.
4 secondary outcomes
Pain intensity (average in past week)
Time frame: 1, 2, 3, 4, 5, 8, 16 weeks
Impact of Diabetic Neuropathic Pain
Time frame: 5, 8, 16 weeks
Neuropathy- and Foot Ulcer-Specific Quality of Life
Time frame: 5, 8, 16 weeks
Fear of Falling
Time frame: 5, 8, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 40495635Hohenschurz-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.
- Full protocol (embargoed until Nov 2024)Link provided by the sponsor.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The sharing of trial data, specifically anonymised individual patient data and summary data, is permissible once the final report of all analyses specified in this report has been published in a scientific journal. External parties can request access to this dataset or the dataset may be shared on an online repository (OSF.io).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hohenschurz-Schmidt, PhD principal investigator
University College of Osteopathy / Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuOst in people with Painful Diabetic Neuropathy, run by University College of Osteopathy at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility (time frame: 12 months from recruitment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.