Acupuncture
ProcedureNeedle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).
Other names: Verum Acupuncture
Completed
NCT Number: NCT02589418
Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A 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.
Completed
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Conditions
Age range
18 year–40 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Clinic of Masticatory Disorders, Removable Prosthodontics, Geriatric and Special Care Dentistry Center of Dental Medicine University of Zurich, Zurich, Canton of Zurich, Switzerland
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About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
Sham-Acupuncture
ProcedureNeedle insertion and manipulation at 4 non-acupoints
No Acupuncture
ProcedureControl intervention: No needle insertion and manipulation
Primary outcomes
-
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.
Secondary outcomes
-
Longer lasting effects of acupuncture on subjective intensity ratings
Time frame: 50 minutes
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.
-
Longer lasting effects of acupuncture on pain-specific changes in heart rate.
Time frame: 50 minutes
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.
-
Longer lasting effects of acupuncture on pain-specific changes in skin conductance.
Time frame: 50 minutes
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.
-
Longer lasting effects of acupuncture on pain-specific changes in respiratory frequency.
Time frame: 50 minutes
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.
-
Changes in skin conductance during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Time frame: 10 minutes
Comparison of changes in the skin conductance measured during the acupuncture/sham-acupuncture and no acupuncture
-
Changes in heart rate variability (HRV) during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Time frame: 10 minutes
Comparison of changes in the HRV measured during the acupuncture/sham-acupuncture and no acupuncture
-
Changes in respiratory frequency during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
Time frame: 10 minutes
Comparison of changes in respiratory frequency measured during the acupuncture/sham-acupuncture and no acupuncture.
-
Frequency of SAEs
Time frame: 1 month
Serious adverse event (SAEs) occurrences will be recorded and their frequency will be calculated.
Other outcomes
-
Expectation towards acupuncture
Time frame: 60 minutes
Acupuncture expectation will be assessed using an acupuncture expectation questionnaire developed by the Institut for Complementary and Integrative Medicine, University Hospital Zurich
-
Anxiety states and traits
Time frame: 60 minutes
For the assessment of anxiety levels, the State-Trait Anxiety Inventory(STAI)(Bieling et al., 1998) questionnaire will be applied.
Sponsors and collaborators
Lead sponsor
University of Zurich
Other
Collaborators
- Charite University, Berlin, Germany
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Registry information
Official study title
Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Randomized, Single Blinded, Sham-controlled Psychophysical Study (Phase1)
Acronym: MAC-DENT1
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Oct 28, 2015
- Registry last updated
- Mar 15, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.