NCT02002520

Brief Summary

Pain is the way our brain interprets certain bodily sensations. It is very difficult to describe or to put into words as perception and tolerance of pain varies widely between individuals. It is known that age, gender and past experience and memory of past experience all contribute to patients' feelings of discomfort and tolerance of pain, but the reason why some patients actually do not experience any pain at all post surgery is still unknown. Because pain affects every person at some point in their lives, it is of utmost importance that we can find more effective analgesic methods, and provide analgesia tailored to an individual's need as well as discovering new methods which may be able to identify those individuals who are more prone to suffering serious, or chronic pain. It has been proposed that epigenetic modifications may play a role in sensitivity to analgesia and response to trauma, such as post surgery. The effects of epigenetic changes on key genes and the role this plays in analgesia sensitivity and pain perception is deserving of further research. Epigenetics is a growing field of study in which there are genetic modifications that do not involve changes to base sequences in a gene, but that result nonetheless in changes to gene expression. It has long been known that changes in gene expression play an important role in the establishment of pain states. But it is not known whether a priming injury can induce lasting epigenetic marks which would result in an increase in both postoperative acute pain and the risk for chronic pain. Only by fully understanding these epigenetic mechanisms will we be able to offer better drugs for the treatment of pain, and to identify those at high risk of postoperative pain and postsurgical chronic pain. The purpose of this study is to determine whether severity of pain following surgical procedures, such as third molar surgery is related to baseline methylation status of the promoter region of IL-6 and TNF-α and changes in methylation status post surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

November 30, 2013

Last Update Submit

January 21, 2014

Conditions

Keywords

Acute painEpigeneticDental pain

Outcome Measures

Primary Outcomes (1)

  • pain score

    From postoperative 1 hour to postoperative 3 months

Secondary Outcomes (1)

  • IL-6 and TNF-α expression

    From postoperative 1 hr to postoperative 3 month

Study Arms (2)

case group

patients undergo third molar surgery

control group

subjects do not require surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects at Prince Philip Dental Hospital and Queen Mary Hospital

You may qualify if:

  • Patient requires third molar surgery for case group and patient does not require surgery for control group
  • Age 18 or above
  • Ability to read and understand the study information and consent form
  • Written consent obtained

You may not qualify if:

  • Patient does not requires third molar surgery for case group and patient requires third molar surgery for control group
  • Age below 18
  • Major cognitive or psychiatric disorders that affect the ability to complete study
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anaesthesiology, The University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Department of Anaesthesiology, The University of Hong Kong

Hong Kong, 0000, Hong Kong

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

RNA and DNA

MeSH Terms

Conditions

Acute PainToothache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic DiseasesFacial Pain

Study Officials

  • Chi W Cheung

    Department of Anaesthesiology, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi W Cheung

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2013

First Posted

December 6, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations