NCT02589418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

October 23, 2015

Last Update Submit

March 14, 2016

Conditions

Experimental Dental Pain

Keywords

Manual acupunctureExperimental dental painPsychophysicsAutonomic nervous systemSubjective pain ratings

Outcome Measures

Primary Outcomes (2)

  • Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre control intervention (no acupuncture) rating differences

    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.

    15 minutes

Secondary Outcomes (8)

  • Longer lasting effects of acupuncture on subjective intensity ratings

    50 minutes

  • Longer lasting effects of acupuncture on pain-specific changes in heart rate.

    50 minutes

  • Longer lasting effects of acupuncture on pain-specific changes in skin conductance.

    50 minutes

  • Longer lasting effects of acupuncture on pain-specific changes in respiratory frequency.

    50 minutes

  • Changes in skin conductance during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).

    10 minutes

  • +3 more secondary outcomes

Other Outcomes (2)

  • Expectation towards acupuncture

    60 minutes

  • Anxiety states and traits

    60 minutes

Study Arms (1)

Healthy subjects

EXPERIMENTAL

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

Procedure: AcupunctureProcedure: Sham-AcupunctureProcedure: No Acupuncture

Interventions

AcupuncturePROCEDURE

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

Also known as: Verum Acupuncture
Healthy subjects
Sham-AcupuncturePROCEDURE

Needle insertion and manipulation at 4 non-acupoints

Healthy subjects
No AcupuncturePROCEDURE

Control intervention: No needle insertion and manipulation

Healthy subjects

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Zurich, Canton of Zurich, 8032, Switzerland

Location

Institute for Complementary and Integrative Medicine, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 9682533BACKGROUND

  • 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.

    PMID: 31521794DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Claudia M Witt, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Claudia M. Witt, MBA

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 28, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

CH(2)