Evoked Potentials after Painful Cutaneous Electrical Stimulation Depict Pain Relief during a Conditioned Pain Modulation
Organizational Data
- DRKS-ID:
- DRKS00012779
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-07-24
- Last update in DRKS:
- 2018-01-16
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Conditioned pain modulation (CPM) evaluates the pain modulating effect of a noxious conditioning stimulus (CS) on another noxious test stimulus (TS), mostly based solely on subjective pain ratings. We used painful cutaneous electrical stimulation (PCES) to induce TS in a novel CPM-model. Additionally, to evaluate a more objective parameter, we recorded the corresponding changes of cortical evoked potentials (PCES-EP or PREP). We examine the CPM-effect in healthy subjects in a randomized controlled cross-over design during immersion of the non-dominant hand into 10°C or 24°C cold water (CS). Using three custom-built concentric surface electrodes, electrical stimuli were applied on the dominant hand, inducing pain of 40-60 on NRS 0-100 (TS). At baseline, during and after CS we assess the electrically induced pain intensity and electrically evoked potentials recorded over the central electrode (Cz).
Health condition or problem studied
- Free text:
- Healthy volunteers
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- We examine the influcence of contralateral applied painful cold water (10°C) on PCES-EPs (Cortical evoked potentials) and PCES (=painful cutaneous electrical stimulation)-induced pain in healthy subjects. After 5 minutes we repeat testing using non-painful cold water (24°C).
- Arm 2:
- We examine the influcence of contralateral applied non-painful cold water on PCES-EPs and PCES-induced pain in healthy subjects. After 5 minutes we repeat testing using painful cold water.
Endpoints
- Primary outcome:
- Primary outcome of this trial is the reduction of PCES-EP induced by painful cold water. Therefore, we assessed the ratio of the amplitude of PCES-EP before and during conditioning cold water.
- Secondary outcome:
- As secondary outcome parameter, we assessed the relief of PCES induced pain using a 101-point numerical rating scale before and during conditioning cold water as a ratio.
Study Design
- Purpose:
- Basic research/physiological study
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- No Entry
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Bochum
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2015-07-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2016-01-01
- Target Sample Size:
- 20
- Final Sample Size:
- 18
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 70 Years
- Additional Inclusion Criteria:
- Healthy subjects, age>18 years, given written informed consent
Exclusion Criteria
Current pain, neuropathy, nerve lesions, topical drug treatment, history of neurological, psychiatric or severe cardiovascular diseases
Addresses
Primary Sponsor
- Address:
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbHBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Neurologische Klinik und PoliklinikBerufsgenossenschaftliches UniversitätsklinikumBergmannsheil GmbHPD Dr. Oliver HöffkenBürkle-de-la-Camp Platz 144789 BochumGermany
- Telephone:
- 00492343020
- Fax:
- 00492343026888
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
Contact for Public Queries
- Address:
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbHPD Dr. Oliver HöffkenBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- 00492343020
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
Principal Investigator
- Address:
- Neurologische Klinik und PoliklinikBerufsgenossenschaftliches UniversitätsklinikumBergmannsheil GmbHPD Dr. Oliver HöffkenBürkle-de-la-Camp Platz 144789 BochumGermany
- Telephone:
- 00492343020
- Fax:
- 00492343026888
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbHBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität BochumGesundheitscampus 3344801 BochumGermany
- Telephone:
- +49-234-79816555
- Fax:
- +49-234-79816556
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-04-17
- Ethics committee number:
- 15-5300
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-06-16
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry