HabituationNCT03237650
Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?
An observational study of Habituation, run by Ruhr University of Bochum.
Trial summary
Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Habituation
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 2016
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy subjects
Who may be able to join
- healthy volunteers
Who cannot join
- any kind of disease
About this study
Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.
- Conditions
- Habituation
- Keywords
- Painful cutaneous electrical stimulation, Conditioned Pain Modulation
- Medical subject headings
- Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100)
Measured: during the measurement
N1P1-amplitude
Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV
Measured: during the measurement
Secondary outcomes (2)
N1-latency
Latency of the peak N1 of painful cutaneous electrical stimulation evoked potentials in msec
Measured: during the measurement
P0N1-amplitude
Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV
Measured: during the measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HabituationStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 33 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, Principal investigator, University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237650
- Sponsor's protocol ID
- PCES-Hab
- Status last verified
- Jul 2017
- First submitted
- 30 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?
- ClinicalTrials.gov ID
- NCT03237650
- Acronym / sponsor ID
- PCES-Hab
- Conditions
- Habituation
- Keywords
- Painful cutaneous electrical stimulation, Conditioned Pain Modulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Aug 2017 (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.
Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy subjects
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- any kind of disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pain relief
Time frame: during the measurement
pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100)
N1P1-amplitude
Time frame: during the measurement
Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV
2 secondary outcomes
N1-latency
Time frame: during the measurement
P0N1-amplitude
Time frame: during the measurement
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 2 Aug 2017.
- 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.
Christoph Maier, Prof Dr med principal investigator
University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Habituation, run by Ruhr University of Bochum.
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 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
pain relief (time frame: during the measurement). 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 2 Aug 2017.