Neuropathic PainNCT02930551
Neuromas as the Cause of Pain
A study testing Lidocaine and Isotonic Saline in people with Neuropathic Pain and Neuroma, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Pain, Neuroma
- What is being tested?
- Lidocaine and Isotonic Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Dec 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with peripheral nerve injury 3 months prior to participation
Who cannot join
- Severe somatic or psychiatric diseases
- Other peripheral neuropathy
- Lack of ability to cooperate to the clinical examination
- Allergy to Lidocaine or similar analgetics
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study
Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.
- Conditions
- Neuropathic Pain, Neuroma
- Being tested
- Lidocaine, Isotonic Saline
- Medical subject headings
- Neuralgia, Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Isotonic SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Lidocaine 2 ml injection with 2% Adrenaline Receives: Drug: Lidocaine |
| Isotonic Saline | Placebo comparator | Isotonic Saline 2 ml Injection Receives: Drug: Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous pain on numerical rating scale (NRS 0-10)
The participant will be asked about spontaneous pain
Measured: 15 minutes after injection
Evoked pain on numerical rating scale (NRS 0-10)
Measured: 15 minutes after injection
Secondary outcomes (4)
Brush allodynia
Assesment of area (cm^2) using a SOMEDIC brush
Measured: 15 minutes after injection
Pinprick hyperalgesia
Assesment of area (cm^2) using a von Frey filament (60 g)
Measured: 15 minutes after injection
Cold allodynia
Assesment of area (cm^2) using a roll (20 degrees celcius)
Measured: 15 minutes after injection
Heat allodynia
Assesment of area (cm^2) using a roll (40 degrees celcius)
Measured: 15 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930551
- Sponsor's protocol ID
- Neurom2016
- Status last verified
- Feb 2019
- First submitted
- 23 Sep 2016
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study
- ClinicalTrials.gov ID
- NCT02930551
- Acronym / sponsor ID
- Neurom2016
- Conditions
- Neuropathic Pain, Neuroma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Oct 2016 (estimated)
- 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.
Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineLidocaine 2 ml injection with 2% Adrenaline |
| Isotonic Saline | Placebo comparator | Drug: Isotonic SalineIsotonic Saline 2 ml Injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with peripheral nerve injury 3 months prior to participation
Key exclusion criteria (4 listed)
- Severe somatic or psychiatric diseases
- Other peripheral neuropathy
- Lack of ability to cooperate to the clinical examination
- Allergy to Lidocaine or similar analgetics
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 |
|---|---|---|
| Lidocaine | Drug | Lidocaine |
| Isotonic Saline | Drug | Isotonic Saline |
Primary outcome
Spontaneous pain on numerical rating scale (NRS 0-10)
Time frame: 15 minutes after injection
The participant will be asked about spontaneous pain
Evoked pain on numerical rating scale (NRS 0-10)
Time frame: 15 minutes after injection
4 secondary outcomes
Brush allodynia
Time frame: 15 minutes after injection
Pinprick hyperalgesia
Time frame: 15 minutes after injection
Cold allodynia
Time frame: 15 minutes after injection
Heat allodynia
Time frame: 15 minutes after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Isotonic Saline in people with Neuropathic Pain and Neuroma, run by Danish Pain Research Center 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spontaneous pain on numerical rating scale (NRS 0-10) (time frame: 15 minutes after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2019.