Hyperalgesia Clinical Trial
Official title:
The Relationship Between Saliva β-endorphins Levels, Sensitivity and Tolerance to Cold Pain and Perception of Pain in Oral Surgery Procedures in Adult Patients
The purpose of this study is to evaluate the correlation between β-endorphin levels in blood
plasma and saliva in healthy participants with different pain sensitivity and in those with
acute pain in oral and maxillofacial region.
Expected results
- Relation between blood plasma and saliva β-endorphins levels
- Differences of blood plasma β-endorphins levels in healthy participants with different
pain sensitivity and in those with acute pain
- Differences of saliva β-endorphins levels in healthy participants with different pain
sensitivity and in those with acute pain
- Objective method of patient's pain sensation evaluation
- Correlation between patient's self-reported understanding of pain levels in oral
surgery procedures, levels in saliva and blood plasma β-endorphins levels and
sensitivity to cold test results
Study protocol:
Selection of participants
1. Evaluation of pain perception in oral surgery procedures by healthy adult participants.
2. Groups formation, according to the results from first stage, resulting in high and low
pain rating participants groups.
3. Control group formation from patients with acute pain in oral and maxillofacial region
Control rating of participants
1. Patients that have been assigned to groups according to subjective pain ratings in oral
surgery procedures will have to repeat the same questionnaire to ensure the correct group
assignment.
2. Patients that have been assigned to groups according to subjective pain ratings in oral
surgery procedures, will undergo the sensitivity and tolerance to cold pain test.
3. Patients that were assigned to control-acute pain group, will be included in further
study stages only with clinically diagnosed cause of acute pain in oral and maxillofacial
region to avoid possible psychogenic or general diseases pain.
Evaluation of β-endorphins - sampling
1. Saliva samples will be collected by all further included participants by one selves
participants with researchers supervision.
2. Blood samples will be collected from forearm veins by researcher. Evaluation of
β-endorphins - laboratorial examination
1. Levels of β-endorphins in saliva and blood will be evaluated according to manufacturer of
β-endorphins evaluation kit for human research. Every sample will be evaluated twice and the
mean level will be evaluated.
Statistical analysis
1. Statistical analysis will be produced to access all possible relationships
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients without reported chronical or acute pain in non-acute-pain group - Patients with acute pain in oral and maxillofacial region with diagnosed cause of pain in acute-pain group - Patients older than 18 years Exclusion Criteria: - Patients undertaking any pain relieving medicine, including non-steroid and opioid medicine - Patients with diagnosed endocrine system diseases - Patients with psychogenic diseases - Patients with pre-injected local anaesthetics - Patients with oncologic diseases - Patients with endocrine system diseases |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Lithuanian University of Health Sciences |
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlations between ß-endorphins levels (pg/mL) and cold pressor test (min:s), pain perception (1-10 points) questionnaire results. | Both, saliva and blood ß-endorphins levels will be compared with cold pressor test results and pain perception in oral surgery test results. Blood ß-endorphin levels will be used only as control measurement, focusing on saliva ß-endorphin levels correlation. | One year | |
Secondary | Differences between acute-pain group and healthy participants groups with different pain sensitivity levels | All data will be compared between acute-pain and healthy participants groups, to determine, if acute-pain causes ß-endorphin levels change. | One year | |
Secondary | Correlation between saliva ß-endorphins and blood plasma ß-endorphins levels | Correlations between saliva and blood plasma ß-endorphin levels will be calculated with the necessity to collect both samples at the same day and to do laboratorial examinations twice for each sample. | One day | |
Secondary | Correlation between pain perception in oral surgery questionnaire and cold pressor test results | Possible correlations between pain perception in oral surgery questionnaire results and various results from cold pressor test will be calculated. Time (min:s) and pain rating points (1-10) will be taken from cold pressor test and compared with questionnaires points sum (1-100) | One year | |
Secondary | Pain perception in oral surgery questionnaire test - retest correlation | Correlation between primary questionnaire rating and secondary questionnaire rating on pain pressor test day will be calculated. | One year |
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