ClinicalTrials.gg
Sign In
RecruitingNCT04699734Updated Jan 7, 2021

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

An interventional study of Xylocaine 1% and NaCl 9mg/ml in Painful Diabetic Neuropathy, Neuropathic Pain and Neuropathy;Peripheral, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-07.

Sponsored by University of Aarhus · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2020, registered Jan 2021).
  • Started Sep 2020; still recruiting 6 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy

Read the detailed description

Both peripheral and central changes in the nervous system contribute to the development of painful diabetic neuropathy, but how these changes contribute to the pain generation remains yet to be fully understood.

The purpose of this study is to evaluate if a peripheral regional nerve block relieves spontaneous pain in painful diabetic polyneuropathy.

02

Conditions studied

  • Painful Diabetic Neuropathy
  • Neuropathic Pain
  • Neuropathy;Peripheral
03

In context

Diabetic Neuropathies

538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.

This study's planned enrollment of 16 is below the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.

Browse Diabetic Neuropathies studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Browse University of Aarhus studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or older.
  • Probably diabetic neuropathy confirmed using the Toronto criteria in a "conservative manner", i.e. three out of three symptoms/signs of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes) 7.
  • Definite or probable neuropathic pain for minimum the last 6 months
  • Mean pain intensity at > 4 NRS the last week17.

Since we expect a large effect of the block it is not necessary to discontinue pain medication.

Exclusion criteria

Exclusion Criteria:

  • Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain.
  • Unable to understand and speak Danish.
  • Non-cooperative.
  • Warfarin or other medication that contraindicate regional anesthesia.
  • Infection in the injection area.
  • Allergy to lidocaine.
  • Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception).
  • Severe psychiatric disease e.g. severe depression during the last 6 months.
  • Alcohol or drug abuse.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (estimated)

Study arms

  • Active comparator
    Xylocaine

    Nerve block

    Diagnostic Test: Xylocaine 1%

  • Placebo comparator
    Isotonic saline

    Nerve block

    Diagnostic Test: NaCl 9mg/ml

Interventions

  • Diagnostic testXylocaine 1%

    Nerve block

  • Diagnostic testNaCl 9mg/ml

    Nerve block

06

What researchers measure

Primary outcomes

  1. Indication of pain relieved extremity

    Number of participants who indicated the leg with lidocaine as most pain relieved 30 minutes after block And number of participants who indicated the leg with saline as most pain relieved 30 minutes after block

    Time frame: 30 minutes

Secondary outcomes

  1. Pain intensity

    Intensity of spontaneous pain (Numeric Rating Scale (NRS) 0-10, 0=no pain 10=worst pain imaginable) 30, 45, 60 and 90 minutes after block

    Time frame: 90 minutes

  2. Hyperalgesia and allodynia

    Intensity of hyperalgesia and allodynia from -5 to 5 (-5 = no sensation, 0=normal sensation, 5=extremely intense sensation) to brush, pinprick, cold and warm at baseline and if there is registered any signs of hyperexcitability at baseline then 35, 60 and 90 minutes after nerve block.

    Time frame: 90 minutes

  3. Pain relief

    Pain relief at 45 minutes after block assessed using a 6-point scale compared to pain intensity at baseline. (-1 = worse pain 0=no relief 1= little 2= moderate 3=good 4=complete)

    Time frame: 45 minutes

  4. Pain symptomps

    Intensity of neuropathic pain symptoms 50 minutes after nerve block Burning: NRS (0-10), 0=no burning 10=worst burning imaginable Squeezing: NRS (0-10), 0=no squeezing 10=worst squeezing imaginable Pressure: NRS (0-10), 0=no pressure 10=worst pressure imaginable Tingling: NRS (0-10), 0=no tingling 10=worst tingling imaginable

    Time frame: 50 minutes

  5. Distribution of evoked pain

    The distribution of any evoked pain to brush, pinprick, cold and warm before and 60 minutes after nerve block will be mapped using a filt pen and afterwards photographed.

    Time frame: 60 minutes

07

Study locations

1 of 1 sites recruiting
  • Danish Pain Research Center, Aarhus University, Aarhus University Hospital
    Aarhus N, Jutland 8200, Denmark
    Recruiting
08

References and documents

Publications

  • Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303. Erratum In: Diabetes Care. 2010 Dec;33(12):2725. PubMed 20876709 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2020 (actual). Primary completion is estimated for Dec 2026, 75 months after the start.

Of 137 non-industry interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 75 months is above that.

Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2021
First posted
Jan 7, 2021
StartActual
Sep 8, 2020
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jan 7, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04699734
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Jan 7, 2021
Start date
Sep 8, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 7, 2021

Study contacts

Ellen L Schaldemose, MD
Contact
ells@clin.au.dk
+45 93501942
Ellen L Schaldemose, MD
principal investigator · Danish Pain Research Center, Aarhus University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetic Neuropathies →

Other studies from this sponsor

University of Aarhus →

Start the discussion