Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Psychophysical Study (Phase1)

NCT ID: NCT02589418

Last Updated: 2016-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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

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Experimental Dental Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy subjects

All subjects participate at 3 experimental conditions (Acupuncture, Sham-Acupuncture and No Acupuncture) at 3 different days in a randomized order.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).

Sham-Acupuncture

Intervention Type PROCEDURE

Needle insertion and manipulation at 4 non-acupoints

No Acupuncture

Intervention Type PROCEDURE

Control intervention: No needle insertion and manipulation

Interventions

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Acupuncture

Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).

Intervention Type PROCEDURE

Sham-Acupuncture

Needle insertion and manipulation at 4 non-acupoints

Intervention Type PROCEDURE

No Acupuncture

Control intervention: No needle insertion and manipulation

Intervention Type PROCEDURE

Other Intervention Names

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Verum Acupuncture

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Claudia Witt

Prof. Dr. med. Claudia M. Witt, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia M Witt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Clinic of Masticatory Disorders, Removable Prosthodontics, Geriatric and Special Care Dentistry Center of Dental Medicine University of Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Institute for Complementary and Integrative Medicine, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 9682533 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31521794 (View on PubMed)

Other Identifiers

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MAC-DENT-Psy

Identifier Type: -

Identifier Source: org_study_id

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