Painful Diabetic NeuropathyNCT04699734
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
A study testing Xylocaine 1% and NaCl 9mg/ml in people with Painful Diabetic Neuropathy and Neuropathic Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy, Neuropathic Pain, Neuropathy;Peripheral
- What is being tested?
- Xylocaine 1% and NaCl 9mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Sep 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Danish Pain Research Center, Aarhus University, Aarhus University Hospital
Aarhus N, Jutland, 8200
Ellen L Schaldemose, MD, 93501942, ells@clin.au.dk
About this study
Official title: Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
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.
- Being tested
- Xylocaine 1%, NaCl 9mg/ml
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocaine 1%Diagnostic test
Nerve block
NaCl 9mg/mlDiagnostic test
Nerve block
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine | Active comparator | Nerve block Receives: Diagnostic Test: Xylocaine 1% |
| Isotonic saline | Placebo comparator | Nerve block Receives: Diagnostic Test: NaCl 9mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (5)
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
Measured: 90 minutes
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.
Measured: 90 minutes
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)
Measured: 45 minutes
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
Measured: 50 minutes
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start8 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen L Schaldemose, MD, Principal investigator, Danish Pain Research Center, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699734
- Sponsor's protocol ID
- BPN2020
- Status last verified
- Dec 2020
- First submitted
- 4 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20876709
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
- ClinicalTrials.gov ID
- NCT04699734
- Acronym / sponsor ID
- BPN2020
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jan 2021 (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.
The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylocaine | Active comparator | Diagnostic Test: Xylocaine 1%Nerve block |
| Isotonic saline | Placebo comparator | Diagnostic Test: NaCl 9mg/mlNerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Xylocaine 1%Nerve block | Diagnostic test | Xylocaine |
| NaCl 9mg/mlNerve block | Diagnostic test | Isotonic saline |
Primary outcome
Indication of pain relieved extremity
Time frame: 30 minutes
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
5 secondary outcomes
Pain intensity
Time frame: 90 minutes
Hyperalgesia and allodynia
Time frame: 90 minutes
Pain relief
Time frame: 45 minutes
Pain symptomps
Time frame: 50 minutes
Distribution of evoked pain
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Background: PubMed 20876709Tesfaye 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.
- Individual participant dataSharing planned: No
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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.
Ellen L Schaldemose, MD principal investigator
Danish Pain Research Center, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylocaine 1% and NaCl 9mg/ml in people with Painful Diabetic Neuropathy and Neuropathic Pain, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Jan 2021. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen L Schaldemose, MD (+45 93501942, ells@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indication of pain relieved extremity (time frame: 30 minutes). 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 NCT04699734, 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 7 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.