Experimental Dental Pain Clinical Trial
— MAC-DENT1Official title:
Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Randomized, Single Blinded, Sham-controlled Psychophysical Study (Phase1)
| Verified date | March 2016 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Clinic of Masticatory Disorders, Removable Prosthodontics, Geriatric and Special Care Dentistry Center of Dental Medicine University of Zurich | Zurich | |
| Switzerland | Institute for Complementary and Integrative Medicine, University Hospital Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich | Charite University, Berlin, Germany, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine |
Switzerland,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Expectation towards acupuncture | Acupuncture expectation will be assessed using an acupuncture expectation questionnaire developed by the Institut for Complementary and Integrative Medicine, University Hospital Zurich | 60 minutes | No |
| Other | Anxiety states and traits | For the assessment of anxiety levels, the State-Trait Anxiety Inventory(STAI)(Bieling et al., 1998) questionnaire will be applied. | 60 minutes | No |
| Primary | Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre control intervention (no acupuncture) rating differences | 15 minutes | No | |
| Primary | 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 | No |
| Secondary | 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. | 50 minutes | No |
| Secondary | 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. | 50 minutes | No |
| Secondary | 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. | 50 minutes | No |
| Secondary | 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. | 50 minutes | No |
| Secondary | 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 | 10 minutes | No |
| Secondary | 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 | 10 minutes | No |
| Secondary | 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. | 10 minutes | No |
| Secondary | Frequency of SAEs | Serious adverse event (SAEs) occurrences will be recorded and their frequency will be calculated. | 1 month | Yes |