Ipsi- and Contralateral HypoesthesiaNCT01540877
A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
A study testing Application of capsaicin 0.6%, Application of local anesthetics (EMLA plaster) and Application of 1 capsaicin 0.6% and 2. EMLA in people with Ipsi- and Contralateral Hypoesthesia, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Main of the present study was to develop a model of concomitant C-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (LA) to examine the sensory alterations after combined C-fiber block and sensitization in both different application orders (sensitization… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ipsi- and Contralateral Hypoesthesia
- What is being tested?
- Application of capsaicin 0.6%, Application of local anesthetics (EMLA plaster) and Application of 1 capsaicin 0.6% and 2. EMLA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Sep 2011
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subject, older than 18 years, provided written informed consent
Who cannot join
- insufficient comprehension of the German language, history of severe internal, neurological or dermatological diseases, substance abuse, manifest psychiatric diseases, chronic and acute pain, any medication intake (except contraceptives in females) regularly or on demand during the last 14 days before study inclusion and during the study period, hypersensitivity to lidocaine or other amide-type anesthetics, hereditary or acquired methemoglobinemia, pregnancy, nursing, abnormal sensory profile in the quantitative sensory testing (QST) with side-to-side differences beyond the normal range at baseline and participation in clinical trials during the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Main of the present study was to develop a model of concomitant C-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (LA) to examine the sensory alterations after combined C-fiber block and sensitization in both different application orders (sensitization of blocked C-fibers and block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect stronger sensory changes during the combined substance application than during the monoapplication. We expect also contralateral sensory alterations mirroring the changes on the intervention site after the combined capsaicin and LA application, being stronger than after sensitization alone absent after C-fiber block alone.
- Conditions
- Ipsi- and Contralateral Hypoesthesia
- Being tested
- Application of capsaicin 0.6%, Application of local anesthetics (EMLA plaster), Application of 1 capsaicin 0.6% and 2. EMLA, Application of 1. EMLA and 2. capsaicin 0.6%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of capsaicin 0.6%Procedure or surgery
topical application of 0.6% capsaicin on the volar forearm
Application of local anesthetics (EMLA plaster)Procedure or surgery
topical application of EMLA on the volar forearm
Application of 1 capsaicin 0.6% and 2. EMLAProcedure or surgery
topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm
Application of 1. EMLA and 2. capsaicin 0.6%Procedure or surgery
topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin application | Experimental | application of 0.6% Receives: Procedure: Application of capsaicin 0.6% |
| Local anesthetics application | Experimental | application of EMLA Receives: Procedure: Application of local anesthetics (EMLA plaster) |
| Combined application of 1. capsaicin 2. local anesthetics | Experimental | application of 1. capsaicin 0.6% and 2. EMLA Receives: Procedure: Application of 1 capsaicin 0.6% and 2. EMLA |
| Combined application of 1. local anesthetics and 2. capsaicin | Experimental | application of 1. EMLA and 2. capsaicin 0.6% Receives: Procedure: Application of 1. EMLA and 2. capsaicin 0.6% |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade of the ipsi- and contralateral hypoesthesia
Measured: 6 months
Secondary outcomes (1)
area of the ipsi- and contralateral hypoesthesia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2011
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 Ipsi- and Contralateral HypoesthesiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540877
- Sponsor's protocol ID
- HypCap
- Status last verified
- Feb 2012
- First submitted
- 23 Feb 2012
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Enax-Krumova EK, Pohl S, Westermann A, Maier C. Ipsilateral and contralateral sensory changes in healthy subjects after experimentally induced concomitant sensitization and hypoesthesia. BMC Neurol. 2017 Mar 23;17(1):60. doi: 10.1186/s12883-017-0839-9.
PubMed 28335745
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
- ClinicalTrials.gov ID
- NCT01540877
- Acronym / sponsor ID
- HypCap
- Conditions
- Ipsi- and Contralateral Hypoesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- First posted
- 29 Feb 2012 (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.
Main of the present study was to develop a model of concomitant C-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (LA) to examine the sensory alterations after combined C-fiber block and sensitization in both different application orders (sensitization of blocked C-fibers and block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect stronger sensory changes during the combined substance application than during the monoapplication. We expect also contralateral sensory alterations mirroring the changes on the intervention site after the combined capsaicin and LA application, being stronger than after sensitization alone absent after C-fiber block alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Capsaicin application | Experimental | Procedure: Application of capsaicin 0.6%application of 0.6% |
| Local anesthetics application | Experimental | Procedure: Application of local anesthetics (EMLA plaster)application of EMLA |
| Combined application of 1. capsaicin 2. local anesthetics | Experimental | Procedure: Application of 1 capsaicin 0.6% and 2. EMLAapplication of 1. capsaicin 0.6% and 2. EMLA |
| Combined application of 1. local anesthetics and 2. capsaicin | Experimental | Procedure: Application of 1. EMLA and 2. capsaicin 0.6%application of 1. EMLA and 2. capsaicin 0.6% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subject, older than 18 years, provided written informed consent
Key exclusion criteria (1 listed)
- insufficient comprehension of the German language, history of severe internal, neurological or dermatological diseases, substance abuse, manifest psychiatric diseases, chronic and acute pain, any medication intake (except contraceptives in females) regularly or on demand during the last 14 days before study inclusion and during the study period, hypersensitivity to lidocaine or other amide-type anesthetics, hereditary or acquired methemoglobinemia, pregnancy, nursing, abnormal sensory profile in the quantitative sensory testing (QST) with side-to-side differences beyond the normal range at baseline and participation in clinical trials during the last month.
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 |
|---|---|---|
| Application of capsaicin 0.6%topical application of 0.6% capsaicin on the volar forearm | Procedure or surgery | Capsaicin application |
| Application of local anesthetics (EMLA plaster)topical application of EMLA on the volar forearm | Procedure or surgery | Local anesthetics application |
| Application of 1 capsaicin 0.6% and 2. EMLAtopical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm | Procedure or surgery | Combined application of 1. capsaicin 2. local anesthetics |
| Application of 1. EMLA and 2. capsaicin 0.6%topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm | Procedure or surgery | Combined application of 1. local anesthetics and 2. capsaicin |
Primary outcome
grade of the ipsi- and contralateral hypoesthesia
Time frame: 6 months
1 secondary outcome
area of the ipsi- and contralateral hypoesthesia
Time frame: 6 months
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 29 Feb 2012.
- Derived from this study: PubMed 28335745Enax-Krumova EK, Pohl S, Westermann A, Maier C. Ipsilateral and contralateral sensory changes in healthy subjects after experimentally induced concomitant sensitization and hypoesthesia. BMC Neurol. 2017 Mar 23;17(1):60. doi: 10.1186/s12883-017-0839-9.
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 Application of capsaicin 0.6%, Application of local anesthetics (EMLA plaster) and Application of 1 capsaicin 0.6% and 2. EMLA in people with Ipsi- and Contralateral Hypoesthesia, run by Ruhr University of Bochum at 1 site in Germany.
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 1 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 29 Feb 2012. 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 Germany. 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. 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?
grade of the ipsi- and contralateral hypoesthesia (time frame: 6 months). 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 NCT01540877, 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 29 Feb 2012.