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Pain and Sensory Changes Assessment in HIV+ Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422695
First Posted: January 17, 2007
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
January 16, 2007
January 17, 2007
March 9, 2016
April 13, 2017
April 13, 2017
January 2007
February 2008   (Final data collection date for primary outcome measure)
  • Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome [ Time Frame: Tests were performed during regular clinical visit. The test duration was about an hour ]
    1. To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.

    To study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:

    • To detect the presence of sensory aberrations in the orofacial complex;
    • To identify which nerve types are involved;
    • To identify the type of orofacial pain based on both sensory testing and clinical findings.

      3.To determine psychological condition and nutrition status in patients with HIV.

      4.To find associations between inherited traits and development of neuropathic pain.

  • Spontaneous Pain Intensity [ Time Frame: The time of the examination ]

    Pain intensity as measured with Visual Analog Scale during the time of examination.

    The subjects were required to report their perceived level of pain on a 10 cm VAS scale from zero to 10 with zero being no pain and 10 representing the worst pain imaginable. Given the ease of use of this method and its current use to measure pain, VAS scales were adapted to measure patient perceived orofacial pain wherein subjects were asked to draw a vertical line at the point on the horizontal line which best represented their pain response. Where left 0 is no pain and right -10 is maximal pain.

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Complete list of historical versions of study NCT00422695 on ClinicalTrials.gov Archive Site
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Pain and Sensory Changes Assessment in HIV+ Patients
Pain and Sensory Changes Assessment in HIV+ Patients, A Model for Pain and Sensory Changes Related Compromised Immune System.

There are about 42 million people in the world afflicted with HIV or AIDS with about 1 million patients in the US.

The epidemiology of orofacial pain has been reported extensively in the literature, yet the prevalence severity and level of pain affecting the head, face, neck and intraoral structures has not been explored in a population of HIV infected individuals.

Pain, in general terms, is a common experience in HIV infected patients, even in the absence of cancer or opportunistic infections. There is a variation in the prevalence of pain in these individuals depending on the stage of disease, care setting, and study methods. The purpose of this study is:

  1. To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.
  2. To study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:

    • To detect the presence of sensory aberrations in the orofacial complex;
    • To identify which nerve types are involved;
    • To identify the type of orofacial pain based on both sensory testing and clinical findings.
  3. To determine psychological condition and nutrition status in patients with HIV.
  4. To find associations between inherited traits and development of neuropathic pain.

Patients and control volunteers will be recruited from the Oral medicine Post-graduate clinic at NJDS. Medical history will be taken and will include age, gender, ethnicity, current and past illnesses, current and past medications, blood reports (CD4 and CD8 counts) which have been obtained during routine medical assessment. The clinician will perform a clinical head and neck examination. The examination shall include an extra-oral, cranial nerve and temporomandibular joint (TMJ) examination, and muscle palpation. A thorough intraoral examination will be performed. Patients will be examined for pathologies of the oral mucosa, teeth and periodontium prior to their participation in the study. The evaluation findings will be reported using the Research Diagnostic Criteria for Temperomandibular disorders. The patient will note level of pain on Visual Analogue Scale if there is any pre-existing orofacial pain. Psychological screening and nutritional questionnaires will be completed by the patient.

Quantitative Sensory Testing will be conducted bilaterally on the face and intraorally on the tongue. Extraorally, the infraorbital and mental nerves regions will be tested bilaterally using thermal and electrical detection thresholds. Intraorally the tongue will be tested bilaterally for thermal and electrical detection threshold.

Many of the differences among people in the way they respond to symptomatic therapies and their individual risk of HIV+ patients with neuropathic pain may be affected by their genetic makeup. We will search for these kinds of associations between inherited traits and development of neuropathic pain in this study.

If the patient presents with evidence for pathologies that requires extraction of any molar (based on clinical and radiographic findings), the patient will be assessed 3 days, 8 days post-extraction and then after 3 weeks for thermal and electrical detection thresholds.

Inclusion criteria:

Group I n = 40 HIV+ with CD4+T cells/mm³ > 500 as determined by previous routine medical examination and from previous blood reports.

Group II n = 40 HIV+ with CD4+T cells/mm³ 200-499 as determined by previous routine medical examination and from previous blood reports.

Group III n = 40 HIV+ with CD4+T cells/mm³ < 200 as determined by previous routine medical examination and from previous blood reports.

Control Group n = 40 Healthy with normal blood reports, without dental pathologies.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Saliva Samples
Non-Probability Sample
HIV +ve subjects Healthy Controls
HIV Infections
Not Provided
  • HIV +
    Groups divided according to CD4 counts
  • Healthy Controls
    HIV -ve subjects
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Group I n = 40 HIV+ with CD4+T cells/mm³ > 500 as determined by previous routine medical examination and from previous blood reports.

Group II n = 40 HIV+ with CD4+T cells/mm³ 200-499 as determined by previous routine medical examination and from previous blood reports.

Group III n = 40 HIV+ with CD4+T cells/mm³ < 200 as determined by previous routine medical examination and from previous blood reports.

Control Group n = 40 Healthy with normal blood reports, without dental pathologies.

Exclusion Criteria:

  • Patients under 18 year of age.
  • Pregnant women.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00422695
0120060172
No
Not Provided
Plan to Share IPD: No
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
Not Provided
Principal Investigator: Eli Eliav, DMD PhD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
January 2017