Influence of Genetics in Pain Sensitivity

NCT00001956 | Completed Phase 2

• 2 other identifiers: 00005500-D-0055
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about the role of genetics in pain sensitivity. Pain perception varies widely among individuals, and information gained from this trial may lead to better methods of preventing and controlling pain. The study consists of two parts, described below. All enrollees will participate in part 1; patients needing oral surgery for removal of third molars may also participate in part 2. Normal volunteers, oral surgery patients, and family members of both groups may be eligible for this study. Part 1 -Sensitivity testing for hot and cold. Participants will rate their pain response to hot and cold stimuli on a scale from "no pain" to the "worst pain imaginable." Heat sensitivity is measured using a small probe placed on the skin for a few seconds. The hottest temperature tested may cause pain for a few seconds but will not produce a burn. Response to cold is measured by placing the hand in cold water for up to 3 minutes and occasionally flexing the fist. Participants will rate their pain level every 15 seconds. In addition to the testing, a blood sample will be drawn to examine for genes related to pain. Part 2 - Oral surgery. Patients will have their third molar removed under a local anesthetic (lidocaine) injected in the mouth and a sedative (Versed) given through a vein in the arm. A small tissue biopsy will be taken from the tissue over one of the third molars. Patients will stay in the clinic for up to 7 hours after surgery while the anesthetic wears off and will rate any pain they may have according to the rating scale used in Part 1 of the study. Pain medication (ketorolac, or Toradol) will be given when needed, and patients will complete pain questionnaires for 3 hours after the drug is given to rate its effectiveness. Patients will receive additional pain relievers, if needed. A second biopsy on the side opposite the first will be taken under local anesthetic to measure changes in chemical signals produced in response to the surgery.

Conditions

Healthy; Hyperalgesia; Pain

Keywords

Genetic Markers; Thermal Pain; Hyperalgesia; Oral Surgery; Cold Pain; Peripheral Nerve; Allodynia; Spinal Cord; Personality Traits; Pain Ratings

Interventions

Blood draw PROCEDURE

Oral surgery PROCEDURE

Tissue biopsy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in need of oral surgery for removal of impacted third molar will be recruited from the local community and by physician or dental referrals.

You may not qualify if:

• Use of prescription and nonprescription analgesics, antihistamines, and antidepressants. No history of psychiatric or neurological disorders or a positive score on the Beck Depression Inventory, those females who are pregnant or nursing.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Brennum J, Kjeldsen M, Jensen K, Jensen TS. Measurements of human pressure-pain thresholds on fingers and toes. Pain. 1989 Aug;38(2):211-7. doi: 10.1016/0304-3959(89)90240-6.

  PMID: 2780075 BACKGROUND

• Casey KL, Minoshima S, Berger KL, Koeppe RA, Morrow TJ, Frey KA. Positron emission tomographic analysis of cerebral structures activated specifically by repetitive noxious heat stimuli. J Neurophysiol. 1994 Feb;71(2):802-7. doi: 10.1152/jn.1994.71.2.802.

  PMID: 8176441 BACKGROUND

• Chen ACN, Dworkin SF, Haug J, Gehrig J. Human pain responsivity in a tonic pain model: psychological determinants. Pain. 1989 May;37(2):143-160. doi: 10.1016/0304-3959(89)90126-7.

  PMID: 2664663 BACKGROUND

MeSH Terms

Conditions

Hyperalgesia; Pain

Interventions

Blood Specimen Collection; Surgery, Oral

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: January 1, 2000
• Study Completion: February 1, 2005
• Last Updated: June 30, 2006

Record last verified: 2005-02

Locations

US (1)