The Relationship Between Saliva β-endorphins Levels, Cold Pressor Test and Perception of Pain in Oral Surgery Procedures

NCT03164161 | Unknown

• 1 other identifier: BEC-OF-8
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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
• Evaluation of pain perception in oral surgery procedures by healthy adult participants.
• Groups formation, according to the results from first stage, resulting in high and low pain rating participants groups.
• Control group formation from patients with acute pain in oral and maxillofacial region Control rating of participants
• Saliva samples will be collected by all further included participants by one selves participants with researchers supervision.
• Blood samples will be collected from forearm veins by researcher. Evaluation of β-endorphins - laboratorial examination

Conditions

Hyperalgesia; Pain Insensitivity, Congenital

Keywords

Pain Sensitivity; Measurement; Cold Pressor; β-endorphins; saliva; oral surgery

Outcome Measures

Primary Outcomes (1)

• Correlations between β-endorphins levels (pg/mL) and cold pressor test (min:s), pain perception (1-10 points) questionnaire results.

  Both, saliva and blood β-endorphins levels will be compared with cold pressor test results and pain perception in oral surgery test results. Blood β-endorphin levels will be used only as control measurement, focusing on saliva β-endorphin levels correlation.

  One year

Secondary Outcomes (4)

• Differences between acute-pain group and healthy participants groups with different pain sensitivity levels

  One year

• Correlation between saliva β-endorphins and blood plasma β-endorphins levels

  One day

• Correlation between pain perception in oral surgery questionnaire and cold pressor test results

  One year

• Pain perception in oral surgery questionnaire test - retest correlation

  One year

Study Arms (4)

Cold Pressor Test Results

ACTIVE COMPARATOR

Participants, enrolling the healthy participants high and low pain perception groups, will undergo cold pressor test. According to the results patients will be assigned according to time (min:s) until first pain felt (pain threshold) and time (min:s) until unbearable pain and test withdraw (pain tolerance). Also, pain ratings (1-10) at same points will be used as participants alignment tool.

Device: Cold pressor test

β-endorphins level in saliva

ACTIVE COMPARATOR

Participants will be sorted according to β-endorphin levels in saliva., therefore the β-endorphins evaluation in saliva intervention will be performed.

Other: β-endorphins evaluation in saliva

β-endorphin level in blood plasma

ACTIVE COMPARATOR

Participants will be sorted according to β-endorphin levels in blood plasma, therefore β-endorphins evaluation in blood plasma will be performed.

Other: β-endorphins evaluation in blood plasma

Pain perception rating

NO INTERVENTION

Healthy participants will be sorted in to groups: high and low pain perception groups, according to the results of questionnaires, containing various oral surgery procedures pain ranking.

Interventions

Cold pressor test DEVICE

Described before.

Cold Pressor Test Results

β-endorphins evaluation in saliva OTHER

Described before.

β-endorphins level in saliva

β-endorphins evaluation in blood plasma OTHER

Described before.

β-endorphin level in blood plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Related Publications (27)

• Sanikop S, Agrawal P, Patil S. Relationship between dental anxiety and pain perception during scaling. J Oral Sci. 2011 Sep;53(3):341-8. doi: 10.2334/josnusd.53.341.

  PMID: 21959662 BACKGROUND

• Kyle BN, McNeil DW, Weaver B, Wilson T. Recall of Dental Pain and Anxiety in a Cohort of Oral Surgery Patients. J Dent Res. 2016 Jun;95(6):629-34. doi: 10.1177/0022034516631977. Epub 2016 Feb 23.

  PMID: 26908629 BACKGROUND

• Randall CL, McNeil DW, Shaffer JR, Crout RJ, Weyant RJ, Marazita ML. Fear of Pain Mediates the Association between MC1R Genotype and Dental Fear. J Dent Res. 2016 Sep;95(10):1132-7. doi: 10.1177/0022034516661151.

  PMID: 27555332 BACKGROUND

• Klages U, Ulusoy O, Kianifard S, Wehrbein H. Dental trait anxiety and pain sensitivity as predictors of expected and experienced pain in stressful dental procedures. Eur J Oral Sci. 2004 Dec;112(6):477-83. doi: 10.1111/j.1600-0722.2004.00167.x.

  PMID: 15560829 BACKGROUND

• Astramskaite I, Poskevicius L, Juodzbalys G. Factors determining tooth extraction anxiety and fear in adult dental patients: a systematic review. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1630-1643. doi: 10.1016/j.ijom.2016.06.019. Epub 2016 Jul 18.

  PMID: 27436789 BACKGROUND

• Duan G, Han C, Wang Q, Guo S, Zhang Y, Ying Y, Huang P, Zhang L, Macala L, Shah P, Zhang M, Li N, Dib-Hajj SD, Waxman SG, Zhang X. A SCN10A SNP biases human pain sensitivity. Mol Pain. 2016 Sep 2;12:1744806916666083. doi: 10.1177/1744806916666083. Print 2016.

  PMID: 27590072 BACKGROUND

• Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.

  PMID: 19837031 BACKGROUND

• National Research Council (US) Committee on Recognition and Alleviation of Pain in Laboratory Animals. Recognition and Alleviation of Pain in Laboratory Animals. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32658/

  PMID: 20662126 BACKGROUND

• Amit Z, Galina ZH. Stress-induced analgesia: adaptive pain suppression. Physiol Rev. 1986 Oct;66(4):1091-120. doi: 10.1152/physrev.1986.66.4.1091.

  PMID: 2876446 BACKGROUND

• Ahmad AH, Zakaria R. Pain in Times of Stress. Malays J Med Sci. 2015 Dec;22(Spec Issue):52-61.

  PMID: 27006638 BACKGROUND

• Dalayeun JF, Nores JM, Bergal S. Physiology of beta-endorphins. A close-up view and a review of the literature. Biomed Pharmacother. 1993;47(8):311-20. doi: 10.1016/0753-3322(93)90080-5.

  PMID: 7520295 BACKGROUND

• Sprouse-Blum AS, Smith G, Sugai D, Parsa FD. Understanding endorphins and their importance in pain management. Hawaii Med J. 2010 Mar;69(3):70-1. No abstract available.

  PMID: 20397507 BACKGROUND

• Backryd E, Ghafouri B, Larsson B, Gerdle B. Do low levels of beta-endorphin in the cerebrospinal fluid indicate defective top-down inhibition in patients with chronic neuropathic pain? A cross-sectional, comparative study. Pain Med. 2014 Jan;15(1):111-9. doi: 10.1111/pme.12248. Epub 2013 Oct 4.

  PMID: 24118997 BACKGROUND

• Zhao YF, Jiang XZ, Hu SH, Liu Y, Miao L, Song CY. [Observation of plasma levels of beta-endorphin in patients with trigeminal neuralgia]. Shanghai Kou Qiang Yi Xue. 2001 Mar;10(1):46-8. Chinese.

  PMID: 14994078 BACKGROUND

• Cunha GS, Ribeiro JL, Oliveira AR. [Levels of beta-endorphin in response to exercise and overtraining]. Arq Bras Endocrinol Metabol. 2008 Jun;52(4):589-98. doi: 10.1590/s0004-27302008000400004. Portuguese.

  PMID: 18604371 BACKGROUND

• Saltychev M, Vastamaki H, Mattie R, McCormick Z, Vastamaki M, Laimi K. Psychometric Properties of the Pain Numeric Rating Scale When Applied to Multiple Body Regions among Professional Musicians. PLoS One. 2016 Sep 7;11(9):e0161874. doi: 10.1371/journal.pone.0161874. eCollection 2016.

  PMID: 27603011 BACKGROUND

• Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol. 2007 Sep;1(5):725-9. doi: 10.1177/193229680700100517.

  PMID: 19885141 BACKGROUND

• Rai B, Kaur J. Salivary stress markers and psychological stress in simulated microgravity: 21 days in 6 degrees head-down tilt. J Oral Sci. 2011 Mar;53(1):103-7. doi: 10.2334/josnusd.53.103.

  PMID: 21467821 BACKGROUND

• Wolf S, Hardy JD. STUDIES ON PAIN. OBSERVATIONS ON PAIN DUE TO LOCAL COOLING AND ON FACTORS INVOLVED IN THE "COLD PRESSOR" EFFECT. J Clin Invest. 1941 Sep;20(5):521-33. doi: 10.1172/JCI101245. No abstract available.

  PMID: 16694857 BACKGROUND

• Mitchell LA, MacDonald RA, Brodie EE. Temperature and the cold pressor test. J Pain. 2004 May;5(4):233-7. doi: 10.1016/j.jpain.2004.03.004.

  PMID: 15162346 BACKGROUND

• Koenig J, Jarczok MN, Ellis RJ, Bach C, Thayer JF, Hillecke TK. Two-week test-retest stability of the cold pressor task procedure at two different temperatures as a measure of pain threshold and tolerance. Pain Pract. 2014 Mar;14(3):E126-35. doi: 10.1111/papr.12142. Epub 2013 Nov 20.

  PMID: 24256148 BACKGROUND

• Lovallo W. The cold pressor test and autonomic function: a review and integration. Psychophysiology. 1975 May;12(3):268-82. doi: 10.1111/j.1469-8986.1975.tb01289.x. No abstract available.

  PMID: 1153632 BACKGROUND

• V Nikolov, M Petkova, B Petrova, K Mineva. Pain perception to the cold pressor test in reproductive - age women: relation to menstrual phase and comparison with men. Trakia J Sci. 12(1):376-380, 2014

  BACKGROUND

• Herr K, Coyne PJ, McCaffery M, Manworren R, Merkel S. Pain assessment in the patient unable to self-report: position statement with clinical practice recommendations. Pain Manag Nurs. 2011 Dec;12(4):230-50. doi: 10.1016/j.pmn.2011.10.002.

  PMID: 22117755 BACKGROUND

• Pain: clinical manual for nursing practice Pain: clinical manual for nursing practice Margo McCaffery Alexander Beebe Mosby Yearbook UK pound17.25 0 7234 1992 2. Nurs Stand. 1994 Dec 7;9(11):55. doi: 10.7748/ns.9.11.55.s69.

  PMID: 27527475 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Mourot L, Bouhaddi M, Regnard J. Effects of the cold pressor test on cardiac autonomic control in normal subjects. Physiol Res. 2009;58(1):83-91. doi: 10.33549/physiolres.931360. Epub 2008 Jan 17.

  PMID: 18198985 BACKGROUND

MeSH Terms

Conditions

Hyperalgesia; Pain Insensitivity, Congenital

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gintaras Juodžbalys, PhD

  Lithuanian Universwity of Health Sciences

  STUDY CHAIR

• Rasa Banienė

  Lithuanian University of Health Sciences

  STUDY CHAIR

Central Study Contacts

Inesa Astramskaitė, DDS

CONTACT

+37067694908; inesa.astr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: May 23, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share