Experimental Dental PainMAC-DENT1NCT02589418
Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Psychophysical Study (Phase1)
A study testing Acupuncture and No Acupuncture in people with Experimental Dental Pain, run by University of Zurich at 2 sites in Switzerland.
Trial summary
The investigators will assess the effects of manual acupuncture on experimental dental pain in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific autonomic nervous system (ANS) reactions. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Experimental Dental Pain
- What is being tested?
- Acupuncture and No Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Oct 2015to Mar 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- right-handed
- Written informed consent
- Fluent in German language
- Sufficient dental sensitivity for the tooth stimulation
- No acupuncture treatment in the previous 12 months
- No medical knowledge about acupuncure
Who cannot join
- Alcohol, drug, and analgesics consumption within the last 24 hours
- Complaints of diseases of the oral cavity
- Pre-existing neurological and(or psychiatric conditions
- History of severe dental pain
- Regular intake of pain medication
- History of brain injuries
- Alcohol and drug abuse
- Chronic diseases that require a permanent intake of drugs
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Clinic of Masticatory Disorders, Removable Prosthodontics, Geriatric and Special Care Dentistry Center of Dental Medicine University of Zurich
Zurich, Canton of Zurich, 8032
Institute for Complementary and Integrative Medicine, University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Randomized, Single Blinded, Sham-controlled Psychophysical Study (Phase1)
The investigators will assess the effects of manual acupuncture on experimental dental pain in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific autonomic nervous system (ANS) reactions.
Read the detailed description
This psychophysical and -physiological study is the first part of a two-phase project which pursues to explore how acupuncture-induced pain modulation interacts with pain-specific brain processing patterns by means of functional magnetic resonance imaging (fMRI) and by using an experimental dental pain model.
In this preceding study, the characterization of manual acupuncture effects on the experimental dental pain model will be tested under laboratory conditions and without restrictions of an fMRI-measurement in order to provide a sound foundation for the following fMRI-experiment. Pain modulating effects of the manual acupuncture intervention (4 points: needle manipulation of bilateral large-intestine 4 (LI4), stomach 6 and 7 (ST6, ST7) ipsilateral to the stimulated tooth) will be compared to sham-acupuncture (insertion and manipulation of 4 non-acupuncture points) and a control intervention (no acupuncture) which will each be performed at 3 different days in a randomized order. Intervention effects on experimental dental pain will be assessed by testing of 36 healthy volunteers by means of subjective pain intensity ratings and pain-specific ANS reactions such as electrodermal activity and heart rate/respiratory changes. Besides laying the groundwork for the following fMRI experiment, this study could provide valuable basic insights into the dynamics of the tested manual acupuncture effects and further provide important knowledge for the planning of future clinical studies encompassing dental conditions and development of acupuncture treatments.
- Conditions
- Experimental Dental Pain
- Being tested
- Acupuncture, Sham-Acupuncture, No Acupuncture
- Keywords
- Manual acupuncture, Experimental dental pain, Psychophysics, Autonomic nervous system, Subjective pain ratings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Also called Verum Acupuncture
Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).
Sham-AcupunctureProcedure or surgery
Needle insertion and manipulation at 4 non-acupoints
No AcupunctureProcedure or surgery
Control intervention: No needle insertion and manipulation
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | All subjects participate at 3 experimental conditions (Acupuncture, Sham-Acupuncture and No Acupuncture) at 3 different days in a randomized order. Receives: Procedure: Acupuncture; Procedure: Sham-Acupuncture; Procedure: No Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre control intervention (no acupuncture) rating differences
Measured: 15 minutes
Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre sham-acupuncture rating differences
In case of a significant effect in outcome 1, outcome 2 will be tested using a hierarchical procedure in order to avoid multiple testing.
Measured: 15 minutes
Secondary outcomes (8)
Longer lasting effects of acupuncture on subjective intensity ratings
Besides the pre-post intervention comparisons (primary outcome), 2 additional timepoints (Total: pre-intervention, post-intervention, 15 min post-intervention, 30 min post-intervention) will be examined to test differences in temporal dynamics between the 3 intervention effects on subjective pain intensity.
Measured: 50 minutes
Longer lasting effects of acupuncture on pain-specific changes in heart rate.
Besides the pre-post intervention comparisons (primary outcome), 2 additional timepoints (Total: pre-intervention, post-intervention, 15 min post-intervention, 30 min post-intervention) will be examined to test differences in temporal dynamics between the 3 intervention effects on pain-specific heart rate alterations.
Measured: 50 minutes
Longer lasting effects of acupuncture on pain-specific changes in skin conductance.
Besides the pre-post intervention comparisons (primary outcome), 2 additional timepoints (Total: pre-intervention, post-intervention, 15 min post-intervention, 30 min post-intervention) will be examined to test differences in temporal dynamics between the 3 intervention effects on pain-specific skin conductance alterations.
Measured: 50 minutes
Longer lasting effects of acupuncture on pain-specific changes in respiratory frequency.
Besides the pre-post intervention comparisons (primary outcome), 2 additional timepoints (Total: pre-intervention, post-intervention, 15 min post-intervention, 30 min post-intervention) will be examined to test differences in temporal dynamics between the 3 intervention effects on pain-specific changes in respiratory frequency.
Measured: 50 minutes
Changes in skin conductance during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Comparison of changes in the skin conductance measured during the acupuncture/sham-acupuncture and no acupuncture
Measured: 10 minutes
Changes in heart rate variability (HRV) during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Comparison of changes in the HRV measured during the acupuncture/sham-acupuncture and no acupuncture
Measured: 10 minutes
Changes in respiratory frequency during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Comparison of changes in respiratory frequency measured during the acupuncture/sham-acupuncture and no acupuncture.
Measured: 10 minutes
Frequency of SAEs
Serious adverse event (SAEs) occurrences will be recorded and their frequency will be calculated.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Experimental Dental PainStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Claudia Witt, University of Zurich
- Investigators
- Claudia M Witt, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589418
- Sponsor's protocol ID
- MAC-DENT-Psy
- Acronym
- MAC-DENT1
- Status last verified
- Mar 2016
- First submitted
- 23 Oct 2015
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bieling PJ, Antony MM, Swinson RP. The State-Trait Anxiety Inventory, Trait version: structure and content re-examined. Behav Res Ther. 1998 Jul-Aug;36(7-8):777-88. doi: 10.1016/s0005-7967(98)00023-0.
PubMed 9682533de Matos NMP, Pach D, Xing JJ, Barth J, Beyer LE, Shi X, Kern A, Lukic N, Ettlin DA, Brugger M, Witt CM. Evaluating the Effects of Acupuncture Using a Dental Pain Model in Healthy Subjects - A Randomized, Cross-Over Trial. J Pain. 2020 Mar-Apr;21(3-4):440-454. doi: 10.1016/j.jpain.2019.08.013. Epub 2019 Sep 12.
PubMed 31521794
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Randomized, Single Blinded, Sham-controlled Psychophysical Study (Phase1)
- ClinicalTrials.gov ID
- NCT02589418
- Acronym / sponsor ID
- MAC-DENT1 / MAC-DENT-Psy
- Conditions
- Experimental Dental Pain
- Keywords
- Manual acupuncture, Experimental dental pain, Psychophysics, Autonomic nervous system, Subjective pain ratings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Charite University, Berlin, Germany
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Oct 2015 (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 investigators will assess the effects of manual acupuncture on experimental dental pain in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific autonomic nervous system (ANS) reactions.
Detailed description
This psychophysical and -physiological study is the first part of a two-phase project which pursues to explore how acupuncture-induced pain modulation interacts with pain-specific brain processing patterns by means of functional magnetic resonance imaging (fMRI) and by using an experimental dental pain model.
In this preceding study, the characterization of manual acupuncture effects on the experimental dental pain model will be tested under laboratory conditions and without restrictions of an fMRI-measurement in order to provide a sound foundation for the following fMRI-experiment. Pain modulating effects of the manual acupuncture intervention (4 points: needle manipulation of bilateral large-intestine 4 (LI4), stomach 6 and 7 (ST6, ST7) ipsilateral to the stimulated tooth) will be compared to sham-acupuncture (insertion and manipulation of 4 non-acupuncture points) and a control intervention (no acupuncture) which will each be performed at 3 different days in a randomized order. Intervention effects on experimental dental pain will be assessed by testing of 36 healthy volunteers by means of subjective pain intensity ratings and pain-specific ANS reactions such as electrodermal activity and heart rate/respiratory changes. Besides laying the groundwork for the following fMRI experiment, this study could provide valuable basic insights into the dynamics of the tested manual acupuncture effects and further provide important knowledge for the planning of future clinical studies encompassing dental conditions and development of acupuncture treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Procedure: Acupuncture, Procedure: Sham-Acupuncture, Procedure: No AcupunctureAll subjects participate at 3 experimental conditions (Acupuncture, Sham-Acupuncture and No Acupuncture) at 3 different days in a randomized order. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- right-handed
- Written informed consent
- Fluent in German language
- Sufficient dental sensitivity for the tooth stimulation
- No acupuncture treatment in the previous 12 months
Key exclusion criteria (8 listed)
- Alcohol, drug, and analgesics consumption within the last 24 hours
- Complaints of diseases of the oral cavity
- Pre-existing neurological and(or psychiatric conditions
- History of severe dental pain
- Regular intake of pain medication
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 |
|---|---|---|
| AcupunctureAlso: Verum AcupunctureNeedle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7). | Procedure or surgery | Healthy subjects |
| Sham-AcupunctureNeedle insertion and manipulation at 4 non-acupoints | Procedure or surgery | Healthy subjects |
| No AcupunctureControl intervention: No needle insertion and manipulation | Procedure or surgery | Healthy subjects |
Primary outcome
Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre control intervention (no acupuncture) rating differences
Time frame: 15 minutes
Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre sham-acupuncture rating differences
Time frame: 15 minutes
In case of a significant effect in outcome 1, outcome 2 will be tested using a hierarchical procedure in order to avoid multiple testing.
8 secondary outcomes
Longer lasting effects of acupuncture on subjective intensity ratings
Time frame: 50 minutes
Longer lasting effects of acupuncture on pain-specific changes in heart rate.
Time frame: 50 minutes
Longer lasting effects of acupuncture on pain-specific changes in skin conductance.
Time frame: 50 minutes
Longer lasting effects of acupuncture on pain-specific changes in respiratory frequency.
Time frame: 50 minutes
Changes in skin conductance during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Time frame: 10 minutes
Changes in heart rate variability (HRV) during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Time frame: 10 minutes
Changes in respiratory frequency during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Time frame: 10 minutes
Frequency of SAEs
Time frame: 1 month
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 15 Mar 2016.
- Background: PubMed 9682533Bieling PJ, Antony MM, Swinson RP. The State-Trait Anxiety Inventory, Trait version: structure and content re-examined. Behav Res Ther. 1998 Jul-Aug;36(7-8):777-88. doi: 10.1016/s0005-7967(98)00023-0.
- Derived from this study: PubMed 31521794de Matos NMP, Pach D, Xing JJ, Barth J, Beyer LE, Shi X, Kern A, Lukic N, Ettlin DA, Brugger M, Witt CM. Evaluating the Effects of Acupuncture Using a Dental Pain Model in Healthy Subjects - A Randomized, Cross-Over Trial. J Pain. 2020 Mar-Apr;21(3-4):440-454. doi: 10.1016/j.jpain.2019.08.013. Epub 2019 Sep 12.
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.
Claudia M Witt, MD principal investigator
University of Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and No Acupuncture in people with Experimental Dental Pain, run by University of Zurich at 2 sites in Switzerland.
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 6 inclusion and 8 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre control intervention (no acupuncture) rating differences (time frame: 15 minutes). 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?
On the ClinicalTrials.gov record for NCT02589418, which also lists 2 linked publications.
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 15 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.