HealthyNCT00001597
Pain Measurement in Healthy Volunteers
An observational study of Healthy and Pain, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study will attempt to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in patients. Normal healthy volunteers and dental patients undergoing third molar extraction may be eligible for this study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Jun 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Normal Volunteers, including NIH employees, will serve as subjects.
No subjects with any painful disease or diseases in which altered pain sensitivity is suspected.
No subjects will be included with poor general health, history of significant illness, history of psychotic disorder or recent emotional distress, serious heart, lung, or liver disease, or pregnancy.
Subjects also will be excluded on the basis of history of allergy to any of the medications, history of chronic or recent drug use that may alter pain response, or chronic drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
This study will attempt to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in patients.
Normal healthy volunteers and dental patients undergoing third molar extraction may be eligible for this study. Participants will undergo the following procedures:
Read more
Volunteers: Volunteers will participate in two 90-minute sessions in which they will receive and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes. The heat stimuli range from 37° (Degree)C to 51° (Degree)C (99° (Degree) F to 124° (Degree) F) and last 2 to 3 seconds. A drug commonly used in dental treatments may be administered during the second session. This will be either a maximum of 0.15 mg fentanyl, a short-acting narcotic pain killer, or a maximum of 5 mg saline, an inactive substance (placebo).
Dental patients: Dental patients will participate in two 60-minute sessions. The first session will be on the day before the third molar extraction, and the second session will be immediately before the dental procedure. The heat stimulus procedure will be identical to that described above for normal healthy volunteers.
Read the detailed description
Mismanaged pain is still a major medical problem. Many pain syndromes have no effective treatment, and many are managed poorly. Basic and applied research on pain treatment is hampered by the unobservable nature of pain sensation and the lack of validated measures of this perception.
The purpose of this protocol is to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in clinical populations. Normal volunteers rate experimentally-evoked pain sensations before and after double-blind administration of the opioid fentanyl or saline placebo. Patients rate experimentally-evoked pain sensations without any drug administration.
- Keywords
- Psychophysics, Validation, Fentanyl, Normal Volunteer, Pain
- Medical subject headings
- Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMar 1997
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001597
- Sponsor's protocol ID
- 970104
- Other IDs
- 97-D-0104
- Status last verified
- Jun 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Gracely RH, McGrath P, Dubner R. Validity and sensitivity of ratio scales of sensory and affective verbal pain descriptors: manipulation of affect by diazepam. Pain. 1978 Jun;5(1):19-29. doi: 10.1016/0304-3959(78)90021-0.
PubMed 673439Gracely RH, Dubner R, McGrath PA. Narcotic analgesia: fentanyl reduces the intensity but not the unpleasantness of painful tooth pulp sensations. Science. 1979 Mar 23;203(4386):1261-3. doi: 10.1126/science.424753.
PubMed 424753Cannon RO 3rd, Quyyumi AA, Mincemoyer R, Stine AM, Gracely RH, Smith WB, Geraci MF, Black BC, Uhde TW, Waclawiw MA, et al. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 May 19;330(20):1411-7. doi: 10.1056/NEJM199405193302003.
PubMed 8159194
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Measurement in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00001597
- Acronym / sponsor ID
- 970104
- Keywords
- Psychophysics, Validation, Fentanyl, Normal Volunteer, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Mar 1997
- Study completion
- Jun 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will attempt to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in patients.
Normal healthy volunteers and dental patients undergoing third molar extraction may be eligible for this study. Participants will undergo the following procedures:
Volunteers: Volunteers will participate in two 90-minute sessions in which they will receive and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes. The heat stimuli range from 37° (Degree)C to 51° (Degree)C (99° (Degree) F to 124° (Degree) F) and last 2 to 3 seconds. A drug commonly used in dental treatments may be administered during the second session. This will be either a maximum of 0.15 mg fentanyl, a short-acting narcotic pain killer, or a maximum of 5 mg saline, an inactive substance (placebo).
Dental patients: Dental patients will participate in two 60-minute sessions. The first session will be on the day before the third molar extraction, and the second session will be immediately before the dental procedure. The heat stimulus procedure will be identical to that described above for normal healthy volunteers.
Detailed description
Mismanaged pain is still a major medical problem. Many pain syndromes have no effective treatment, and many are managed poorly. Basic and applied research on pain treatment is hampered by the unobservable nature of pain sensation and the lack of validated measures of this perception.
The purpose of this protocol is to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in clinical populations. Normal volunteers rate experimentally-evoked pain sensations before and after double-blind administration of the opioid fentanyl or saline placebo. Patients rate experimentally-evoked pain sensations without any drug administration.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 673439Gracely RH, McGrath P, Dubner R. Validity and sensitivity of ratio scales of sensory and affective verbal pain descriptors: manipulation of affect by diazepam. Pain. 1978 Jun;5(1):19-29. doi: 10.1016/0304-3959(78)90021-0.
- Background: PubMed 424753Gracely RH, Dubner R, McGrath PA. Narcotic analgesia: fentanyl reduces the intensity but not the unpleasantness of painful tooth pulp sensations. Science. 1979 Mar 23;203(4386):1261-3. doi: 10.1126/science.424753.
- Background: PubMed 8159194Cannon RO 3rd, Quyyumi AA, Mincemoyer R, Stine AM, Gracely RH, Smith WB, Geraci MF, Black BC, Uhde TW, Waclawiw MA, et al. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 May 19;330(20):1411-7. doi: 10.1056/NEJM199405193302003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Pain, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001597, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.