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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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.

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • New Jersey Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV +ve subjects Healthy Controls

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIV +; Groups divided according to CD4 counts
Healthy Controls; HIV -ve subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome	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.	Tests were performed during regular clinical visit. The test duration was about an hour
Spontaneous Pain Intensity	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.	The time of the examination

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Investigators: Principal Investigator: Eli Eliav, DMD PhD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: January 16, 2007
• First Submitted That Met QC Criteria: January 16, 2007
• First Posted (Estimate): January 17, 2007

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Treatment Experienced; Neuropathy; Treatment Naive; Quantitative Sensory Testing
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 0120060172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO