Clinical trial NCT02589418: Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Psychophysical Study (Phase1)
Official title: Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Randomized, Single Blinded, Sham-controlled Psychophysical Study (Phase1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental Dental Pain
Keywords: Manual acupuncture
Experimental dental pain
Psychophysics
Autonomic nervous system
Subjective pain ratings
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Charite University, Berlin, Germany
First posted: 2015-10-28
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre control intervention (no acupuncture) rating differences
timeFrame: 15 minutes
measure: Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre sham-acupuncture rating differences
timeFrame: 15 minutes
Secondary outcomes:
measure: Longer lasting effects of acupuncture on subjective intensity ratings
timeFrame: 50 minutes
measure: Longer lasting effects of acupuncture on pain-specific changes in heart rate.
timeFrame: 50 minutes
measure: Longer lasting effects of acupuncture on pain-specific changes in skin conductance.
timeFrame: 50 minutes
measure: Longer lasting effects of acupuncture on pain-specific changes in respiratory frequency.
timeFrame: 50 minutes
measure: Changes in skin conductance during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
timeFrame: 10 minutes
measure: Changes in heart rate variability (HRV) during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
timeFrame: 10 minutes
measure: Changes in respiratory frequency during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).
timeFrame: 10 minutes
measure: Frequency of SAEs
timeFrame: 1 month
Other outcomes:
measure: Expectation towards acupuncture
timeFrame: 60 minutes
measure: Anxiety states and traits
timeFrame: 60 minutes
Locations:
city: Zurich
country: Switzerland
facility: Clinic of Masticatory Disorders, Removable Prosthodontics, Geriatric and Special Care Dentistry Center of Dental Medicine University of Zurich
city: Zurich
country: Switzerland
facility: Institute for Complementary and Integrative Medicine, University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Claudia M Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: de 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.