Completed

NCT Number: NCT00422695

Pain and Sensory Changes Assessment in HIV+ Patients

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New Jersey Dental School

Newark, New Jersey, 07101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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
- 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.

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Registry information

Official study title

Pain and Sensory Changes Assessment in HIV+ Patients, A Model for Pain and Sensory Changes Related Compromised Immune System.

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jan 17, 2007
Registry last updated: Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed