NCT00362167

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2001

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2006

Completed
Last Updated

July 2, 2017

Status Verified

December 13, 2006

First QC Date

August 8, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Clinical ExperienceEducational TrainingPain SyndromesAnalgesiaPain MedicineTherapyNeuropathicChronic PainAcute PainAnalgesicsMedicationEvaluation

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

PainSomatoform DisordersAgnosiaChronic PainAcute Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

February 15, 2001

Study Completion

December 13, 2006

Last Updated

July 2, 2017

Record last verified: 2006-12-13

Locations