Healthy SubjectsNCT02808611
Influence of Propranolol on Conditioned Pain Modulation
A study testing propranolol in people with Healthy Subjects, run by Kristian Kjær Petersen at 1 site in Denmark.
Trial summary
An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy controls and pain patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- propranolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2016to Jan 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
Who cannot join
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous history of neurologic, musculoskeletal, mental illnesses or a chronic pain condition
- Lack of ability to cooperate
- Current use of medications that may affect the trial, e.g., analgesics, anti-inflammatory drugs
- Consumption of alcohol, caffeine, nicotine or painkillers the morning and until termination of the study on the study day
- Recent history of acute pain affecting the lower limb
Show all 11Show fewer
- Participation in other pain trials throughout the study period
- Known diagnosis of cardio vascular diseases (low blood pressure, heart conditions)
- Asthma
- Decreased function of liver and kidneys
- Diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Sensory Motor Interaction, Aalborg University
Aalborg East, 9220
About this study
Official title: Konditionerende Smertestimuli - Sammenligning af Forskellige Test og Konditioneringsmodaliteter
An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy controls and pain patients. A number of studies indicate that the autonomic nervous system (ANS) responds to painful stimulation by parasympathetic activity withdrawal and up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether these responses predict individual pain susceptibility or CPM efficacy and whether different pain modalities evoke different physiological stress responses, i.e. do individuals with low pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain levels/CPM efficacy.
This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of the ANS will yield decreased CPM efficacy.
- Conditions
- Healthy Subjects
- Being tested
- propranolol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
Reduction of the ANS response
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Active comparator | Propranolol is a beta-blocker Receives: Drug: propranolol |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPM efficacy
A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.
Measured: 1-2 hours after propranolol/placebo and after 10 minutes break.
Secondary outcomes (3)
Temporal summation of pain
10 stimuli will be applied and subjects will back asked to rate the pain for each individual stimuli.
Measured: 1-2 hours after propranolol/placebo and after 10 minutes break.
Heart-rate variability
Two-point Heart-rate variability recording will be conducted using the Polar RS800CX heart rate monitor.
Measured: 1-2 hours after propranolol/placebo and after 10 minutes break.
Offset analgesia
Temperatures ranging from 45-48°C will be applied to the forearm in three phases (phase 1: 5 seconds, phase 2: 5 seconds, and phase 3: 20 seconds). The subjects will be asked to assess the pain of the thermal stimuli using the electronic VAS scale.
Measured: 1-2 hours after propranolol/placebo and after 10 minutes break.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionJan 2017
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 Healthy SubjectsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristian Kjær Petersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristian Kjær Petersen, Aalborg University
- Investigators
- KRISTIAN K PETERSEN, Ph.D., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808611
- Sponsor's protocol ID
- N-20150055
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2016
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersen KK, Andersen HH, Tsukamoto M, Tracy L, Koenig J, Arendt-Nielsen L. The effects of propranolol on heart rate variability and quantitative, mechanistic, pain profiling: a randomized placebo-controlled crossover study. Scand J Pain. 2018 Jul 26;18(3):479-489. doi: 10.1515/sjpain-2018-0054.
PubMed 29858911
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Konditionerende Smertestimuli - Sammenligning af Forskellige Test og Konditioneringsmodaliteter
- ClinicalTrials.gov ID
- NCT02808611
- Acronym / sponsor ID
- N-20150055
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kristian Kjær PetersenUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Jun 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.
An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy controls and pain patients. A number of studies indicate that the autonomic nervous system (ANS) responds to painful stimulation by parasympathetic activity withdrawal and up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether these responses predict individual pain susceptibility or CPM efficacy and whether different pain modalities evoke different physiological stress responses, i.e. do individuals with low pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain levels/CPM efficacy.
This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of the ANS will yield decreased CPM efficacy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Active comparator | Drug: propranololPropranolol is a beta-blocker |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (11 listed)
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous history of neurologic, musculoskeletal, mental illnesses or a chronic pain condition
- Lack of ability to cooperate
- Current use of medications that may affect the trial, e.g., analgesics, anti-inflammatory drugs
- Consumption of alcohol, caffeine, nicotine or painkillers the morning and until termination of the study on the study day
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 |
|---|---|---|
| propranololReduction of the ANS response | Drug | Propranolol |
| Placebo | Drug | Placebo |
Primary outcome
CPM efficacy
Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.
A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.
3 secondary outcomes
Temporal summation of pain
Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.
Heart-rate variability
Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.
Offset analgesia
Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.
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 28 Jun 2017.
- Derived from this study: PubMed 29858911Petersen KK, Andersen HH, Tsukamoto M, Tracy L, Koenig J, Arendt-Nielsen L. The effects of propranolol on heart rate variability and quantitative, mechanistic, pain profiling: a randomized placebo-controlled crossover study. Scand J Pain. 2018 Jul 26;18(3):479-489. doi: 10.1515/sjpain-2018-0054.
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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.
KRISTIAN K PETERSEN, Ph.D. principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propranolol in people with Healthy Subjects, run by Kristian Kjær Petersen 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 11 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 28 Jun 2017. 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?
CPM efficacy (time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.). 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 NCT02808611, 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 28 Jun 2017.