PainNCT00362167
Pain Evaluation and Treatment
An observational study of Pain, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study offers evaluation and treatment for patients with a spectrum of acute and chronic pain syndromes. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Pain
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2001to 13 Dec 2006
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of 4 years of age and older, both genders, and all racial/ethnic groups with acute or chronic pain that will help the Branch fulfill its objectives.
- Women of childbearing potential, or who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus. The diagnostic tests will only include medically-indicated radiation exposure.
- Referral is needed from the patients' physician or dentist.
Who cannot join
- Patients with significant cognitive impairment.
- Pregnancy or lactation, if this status precludes proposed diagnostic procedures or therapies.
- Patients with serious organ system dysfunction (e.g. heart failure, ischemic heart disease).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation and Treatment of Pain (Training Protocol)
This study offers evaluation and treatment for patients with a spectrum of acute and chronic pain syndromes. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purposes of the study are: 1) to allow physicians in NIDCR's Pain and Neurosensory Mechanisms Branch to gain more knowledge about treating acute and chronic pain and possibly identify new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.)
Patients 12 years of age and older with an acute or chronic pain syndrome may be eligible for this study. Women of childbearing potential and women who are pregnant or breastfeeding will not be enrolled in this study, drugs may have unknown or untoward side effects on the baby.
Read more
Participants will provide a medical history, as well as occupational and social information. They will have a standard neurological examination, including a test of cognitive (thinking) abilities, muscular function, reflexes and sensory examination. The latter involves testing with a pin placed on the surface of the skin. Participants will also have routine blood tests and will fill out questionnaires on their daily functioning and psychological well being. Additional procedures may include magnetic resonance imaging (MRI) scans and possible referral to a psychiatrist for evaluation of depression or emotional difficulties.
Participants will be treated according to their individual pain problem. Treatments may include medicines, exercises, physical therapy, nerve blocks and dietary changes. Medicines given in this study are commonly used by doctors to treat pain, but for many, there is little research to back up their use. This study will provide information on the effectiveness of these treatments. Participants will keep a daily log in which they rate their pain, record any procedures they undergo outside the study, such as injections and exercises, and record medication side effects.
Participation in the study will end based on the researcher's assessment of the patient's response to treatment. The study doctor will provide the patient's referring doctor a report of medications or other treatments used in the study. At the last visit, patients will fill out the same questionnaires they filled out during the first visit.
Read the detailed description
The function of this protocol is to allow the clinic pain research fellows to gain additional knowledge in the management of acute and chronic pain. Patients enrolled in this protocol will be evaluated and treated according to available procedures and therapeutic modalities used in clinical practice. The evaluation and treatment of these patients may lead to ideas for future protocols.
By allowing for the care of persons with a spectrum of pain syndromes, this protocol will be valuable for the training of the pain fellow as well. The pain group at the NIDCR is free to choose those diseases that interest them.
Patients in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any of the new clinical studies of the Pain and Neurosensory Mechanisms branch of the NIDCR as they are developed. If eligible, patients may be asked to participate in the new protocol. However they will not be required to enter any new protocol and their decision to participate will be entirely voluntary.
- Conditions
- Pain
- Keywords
- Clinical Experience, Educational Training, Pain Syndromes, Analgesia, Pain Medicine, Therapy, Neuropathic, Chronic Pain, Acute Pain, Analgesics, Medication, Evaluation
- Medical subject headings
- Pain, Somatoform Disorders, Agnosia, Chronic Pain, Acute Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study start15 Feb 2001
- Study completion13 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 50 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
- NCT00362167
- Sponsor's protocol ID
- 010092
- Other IDs
- 01-D-0092
- Status last verified
- 13 Dec 2006
- First submitted
- 8 Aug 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment of Pain (Training Protocol)
- ClinicalTrials.gov ID
- NCT00362167
- Acronym / sponsor ID
- 010092
- Conditions
- Pain
- Keywords
- Clinical Experience, Educational Training, Pain Syndromes, Analgesia, Pain Medicine, Therapy, Neuropathic, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 15 Feb 2001
- Study completion
- 13 Dec 2006
- First posted
- 9 Aug 2006 (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 offers evaluation and treatment for patients with a spectrum of acute and chronic pain syndromes. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purposes of the study are: 1) to allow physicians in NIDCR's Pain and Neurosensory Mechanisms Branch to gain more knowledge about treating acute and chronic pain and possibly identify new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.)
Patients 12 years of age and older with an acute or chronic pain syndrome may be eligible for this study. Women of childbearing potential and women who are pregnant or breastfeeding will not be enrolled in this study, drugs may have unknown or untoward side effects on the baby.
Participants will provide a medical history, as well as occupational and social information. They will have a standard neurological examination, including a test of cognitive (thinking) abilities, muscular function, reflexes and sensory examination. The latter involves testing with a pin placed on the surface of the skin. Participants will also have routine blood tests and will fill out questionnaires on their daily functioning and psychological well being. Additional procedures may include magnetic resonance imaging (MRI) scans and possible referral to a psychiatrist for evaluation of depression or emotional difficulties.
Participants will be treated according to their individual pain problem. Treatments may include medicines, exercises, physical therapy, nerve blocks and dietary changes. Medicines given in this study are commonly used by doctors to treat pain, but for many, there is little research to back up their use. This study will provide information on the effectiveness of these treatments. Participants will keep a daily log in which they rate their pain, record any procedures they undergo outside the study, such as injections and exercises, and record medication side effects.
Participation in the study will end based on the researcher's assessment of the patient's response to treatment. The study doctor will provide the patient's referring doctor a report of medications or other treatments used in the study. At the last visit, patients will fill out the same questionnaires they filled out during the first visit.
Detailed description
The function of this protocol is to allow the clinic pain research fellows to gain additional knowledge in the management of acute and chronic pain. Patients enrolled in this protocol will be evaluated and treated according to available procedures and therapeutic modalities used in clinical practice. The evaluation and treatment of these patients may lead to ideas for future protocols.
By allowing for the care of persons with a spectrum of pain syndromes, this protocol will be valuable for the training of the pain fellow as well. The pain group at the NIDCR is free to choose those diseases that interest them.
Patients in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any of the new clinical studies of the Pain and Neurosensory Mechanisms branch of the NIDCR as they are developed. If eligible, patients may be asked to participate in the new protocol. However they will not be required to enter any new protocol and their decision to participate will be entirely voluntary.
Study design
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of 4 years of age and older, both genders, and all racial/ethnic groups with acute or chronic pain that will help the Branch fulfill its objectives.
- Women of childbearing potential, or who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus. The diagnostic tests will only include medically-indicated radiation exposure.
- Referral is needed from the patients' physician or dentist.
Key exclusion criteria (3 listed)
- Patients with significant cognitive impairment.
- Pregnancy or lactation, if this status precludes proposed diagnostic procedures or therapies.
- Patients with serious organ system dysfunction (e.g. heart failure, ischemic heart disease).
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 2 Jul 2017.
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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 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.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. 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?
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 2 Jul 2017.