Clinical trial NCT00422695: Pain and Sensory Changes Assessment in HIV+ Patients
Official title: Pain and Sensory Changes Assessment in HIV+ Patients, A Model for Pain and Sensory Changes Related Compromised Immune System.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
Quantitative Sensory Testing
Neuropathy
Treatment Experienced
Treatment Naive
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV +ve subjects Healthy Controls

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome
timeFrame: Tests were performed during regular clinical visit. The test duration was about an hour
measure: Spontaneous Pain Intensity
timeFrame: The time of the examination
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: New Jersey Dental School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Eli Eliav, DMD PhD
role: PRINCIPAL_INVESTIGATOR
References: