Peripheral Nerve InjuryNCT01596491
Study of Possible Changes in QST After Application of Capsaicin on Patients With Peripheral Neuropathic Pain
An observational study of Peripheral Nerve Injury and Postherpetic Neuralgia, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use of capsaicin on skin. The investigators first experiences with capsaicin in patients with peripheral nerve injury showed changes in the sensibility, which achieved its maximal extent after four weeks and was regressive, but not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Injury, Postherpetic Neuralgia
- What is being tested?
- quantitative sensory testing (QST)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Nov 2012
- Phase
- Observational
- 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
Study population: proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia)
Who may be able to join
- age >18 years with signed informed consent
- with planned topical application of capsaicin (8%) and with no involvement in any other study
- with neurological proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia) and with remaining moderate pain intensity under the current treatment (> NRS 3; numeric rating scale 0-10)
- some remaining sensory function at the baseline QST with z-scores ≥ - 3 for cold, warmth and tactile thresholds
Who cannot join
- with missing informed consent
- with any contraindications for capsaicin application
- with diabetes mellitus,
- using lidocaine patch in the test area in the last 6 months before enrollment
- with inadequate knowledge of the german language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kind and Duration of Possible Changes of the Sensory Profiles After the Topical Application of Capsaicin (8%) in Patients With Peripheral Neuropathic Pain
The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use of capsaicin on skin.
The investigators first experiences with capsaicin in patients with peripheral nerve injury showed changes in the sensibility, which achieved its maximal extent after four weeks and was regressive, but not completely abolished 1,5 months after application.
In this study the investigators hope to specify, how long and in which way exactly this changes in sensibility appear.
Read the detailed description
The topical application of a high dosage of capsaicin (8%) is a new promising approach. There is only little knowledge about the extent and the duration of drug-induced changes of detection and pain thresholds based on a currently recommended standardized quantitative sensory testing (QST). The assessment of QST changes would be an important step forward to understand the way of action as well as the time course of the presumed recovering of the C-fiber function after topical application of a high concentration capsaicin patch.
10 patients suffering from peripheral neuropathic pain due to peripheral nerve injury and 10 patients suffering from postherpetic neuralgia will be investigated by QST following the protocol of DFNS (German Research Network on Neuropathic Pain), using both thermal and mechanical nociceptive as well as non-nociceptive stimuli.
QST will be performed at the following times:
- at baseline
- 2, 4, 6, 8 weeks later, and every two weeks at least until re-occurrence of pain and/or recovering of the capsaicin-induced worsening of the C-fiber function.
- Conditions
- Peripheral Nerve Injury, Postherpetic Neuralgia
- Being tested
- quantitative sensory testing (QST)
- Keywords
- peripheral nerve injury, postherpetic neuralgia, PNI, PHN, Capsaicin, QST, quantitative sensory testing, sensory profile, neuropathic pain
- Medical subject headings
- Peripheral Nerve Injuries, Neuralgia, Postherpetic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitative sensory testing (QST)Procedure or surgery
with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified
| Study group | Role | What they receive |
|---|---|---|
| patients with peripheral nerve injury | 10 patients with neuropathic pain, because of peripheral nerve injury will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits Receives: Procedure: quantitative sensory testing (QST) | |
| patients with postherpetic neuralgia | 10 patients with neuropathic pain, because of postherpetic neuralgia will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits Receives: Procedure: quantitative sensory testing (QST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)
Measured: 8 weeks after capsaicin-patch (8%) application
Extent of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)
Measured: 8 weeks after capsaicin-patch (8%) application
Secondary outcomes (4)
Decrease of thermal Hyperalgesia
change of thermal hyperalgesia measured by QST (z-value of heat pain and cold pain threshold)from baseline to 8 weeks after capsaicin-application
Measured: 8 weeks after capsaicin-patch (8%) application
Decrease of mechanical hyperalgesia
change of mechanical hyperalgesia measured by QST (z-value of mechanical pain threshold and mechanical pain sensitivity) from baseline to 8 weeks after capsaicin-application
Measured: 8 weeks after capsaicin-patch (8%) application
Decrease of dynamical mechanical allodynia
change of dynamical mechanical allodynia measured by QST from baseline to 8 weeks after capsaicin-application
Measured: 8 weeks after capsaicin-patch (8%) application
Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application
comparison of z-values for cold, warmth and mechanical detection threshold to the outcome of the german versions of the following questionnaires: PainDETECT, NPSI (Neuropathic Pain Symptom Inventory) and Patient's global impression of change (PGIC), analyzed by ANCOVA
Measured: 8 weeks after application of capsaicin-patch (8%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startApr 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, Prof.Dr.med, Study director, University hospital Bergmannsheil department of pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596491
- Sponsor's protocol ID
- Capsaicin2011
- Status last verified
- Dec 2012
- First submitted
- 23 Feb 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kind and Duration of Possible Changes of the Sensory Profiles After the Topical Application of Capsaicin (8%) in Patients With Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01596491
- Acronym / sponsor ID
- Capsaicin2011
- Conditions
- Peripheral Nerve Injury, Postherpetic Neuralgia
- Keywords
- peripheral nerve injury, postherpetic neuralgia, PNI, PHN, Capsaicin, QST, quantitative sensory testing, sensory profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 May 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.
The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use of capsaicin on skin.
The investigators first experiences with capsaicin in patients with peripheral nerve injury showed changes in the sensibility, which achieved its maximal extent after four weeks and was regressive, but not completely abolished 1,5 months after application.
In this study the investigators hope to specify, how long and in which way exactly this changes in sensibility appear.
Detailed description
The topical application of a high dosage of capsaicin (8%) is a new promising approach. There is only little knowledge about the extent and the duration of drug-induced changes of detection and pain thresholds based on a currently recommended standardized quantitative sensory testing (QST). The assessment of QST changes would be an important step forward to understand the way of action as well as the time course of the presumed recovering of the C-fiber function after topical application of a high concentration capsaicin patch.
10 patients suffering from peripheral neuropathic pain due to peripheral nerve injury and 10 patients suffering from postherpetic neuralgia will be investigated by QST following the protocol of DFNS (German Research Network on Neuropathic Pain), using both thermal and mechanical nociceptive as well as non-nociceptive stimuli.
QST will be performed at the following times:
- at baseline
- 2, 4, 6, 8 weeks later, and every two weeks at least until re-occurrence of pain and/or recovering of the capsaicin-induced worsening of the C-fiber function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with peripheral nerve injury | – | Procedure: quantitative sensory testing (QST)10 patients with neuropathic pain, because of peripheral nerve injury will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits |
| patients with postherpetic neuralgia | – | Procedure: quantitative sensory testing (QST)10 patients with neuropathic pain, because of postherpetic neuralgia will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia)
Key inclusion criteria (4 listed)
- age >18 years with signed informed consent
- with planned topical application of capsaicin (8%) and with no involvement in any other study
- with neurological proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia) and with remaining moderate pain intensity under the current treatment (> NRS 3; numeric rating scale 0-10)
- some remaining sensory function at the baseline QST with z-scores ≥ - 3 for cold, warmth and tactile thresholds
Key exclusion criteria (5 listed)
- with missing informed consent
- with any contraindications for capsaicin application
- with diabetes mellitus,
- using lidocaine patch in the test area in the last 6 months before enrollment
- with inadequate knowledge of the german language
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 |
|---|---|---|
| quantitative sensory testing (QST)with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified | Procedure or surgery | patients with peripheral nerve injury, patients with postherpetic neuralgia |
Primary outcome
Duration of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds
Time frame: 8 weeks after capsaicin-patch (8%) application
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)
Extent of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds
Time frame: 8 weeks after capsaicin-patch (8%) application
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)
4 secondary outcomes
Decrease of thermal Hyperalgesia
Time frame: 8 weeks after capsaicin-patch (8%) application
Decrease of mechanical hyperalgesia
Time frame: 8 weeks after capsaicin-patch (8%) application
Decrease of dynamical mechanical allodynia
Time frame: 8 weeks after capsaicin-patch (8%) application
Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application
Time frame: 8 weeks after application of capsaicin-patch (8%)
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 20 Dec 2012.
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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.
Christoph Maier, Prof.Dr.med study director
University hospital Bergmannsheil department of pain management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injury and Postherpetic Neuralgia, 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 4 inclusion and 5 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 20 Dec 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?
Duration of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds (time frame: 8 weeks after capsaicin-patch (8%) application). 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 20 Dec 2012.