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Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Psychophysical Study (Phase1) (MAC-DENT1)

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ClinicalTrials.gov Identifier: NCT02589418
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : March 15, 2016
Sponsor:
Collaborators:
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Claudia Witt, University of Zurich

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.

Condition or disease Intervention/treatment Phase
Experimental Dental Pain Procedure: Acupuncture Procedure: Sham-Acupuncture Procedure: No Acupuncture Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Randomized, Single Blinded, Sham-controlled Psychophysical Study (Phase1)
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Healthy subjects
All subjects participate at 3 experimental conditions (Acupuncture, Sham-Acupuncture and No Acupuncture) at 3 different days in a randomized order.
Procedure: Acupuncture
Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).
Other Name: Verum Acupuncture

Procedure: Sham-Acupuncture
Needle insertion and manipulation at 4 non-acupoints

Procedure: No Acupuncture
Control intervention: No needle insertion and manipulation




Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. Frequency of SAEs [ Time Frame: 1 month ]
    Serious adverse event (SAEs) occurrences will be recorded and their frequency will be calculated.


Other Outcome Measures:
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589418


Locations
Switzerland
Clinic of Masticatory Disorders, Removable Prosthodontics, Geriatric and Special Care Dentistry Center of Dental Medicine University of Zurich
Zurich, Switzerland, 8032
Institute for Complementary and Integrative Medicine, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia M Witt, MD University of Zurich

Publications:
Responsible Party: Claudia Witt, Prof. Dr. med. Claudia M. Witt, MBA, University of Zurich
ClinicalTrials.gov Identifier: NCT02589418     History of Changes
Other Study ID Numbers: MAC-DENT-Psy
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016

Keywords provided by Claudia Witt, University of Zurich:
Manual acupuncture
Experimental dental pain
Psychophysics
Autonomic nervous system
Subjective pain ratings

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms