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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).
Needle insertion and manipulation at 4 non-acupoints
Control intervention: No needle insertion and manipulation
Clinic of Masticatory Disorders, Removable Prosthodontics, Geriatric and Special Care Dentistry Center of Dental Medicine University of Zurich
Zurich, Canton of Zurich, Switzerland
Institute for Complementary and Integrative Medicine, University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
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
In case of a significant effect in outcome 1, outcome 2 will be tested using a hierarchical procedure in order to avoid multiple testing.
Time frame: 15 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 50 minutes
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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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 10 minutes
Frequency of SAEs
Serious adverse event (SAEs) occurrences will be recorded and their frequency will be calculated.
Time frame: 1 month