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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00422695
Enrollment
143
Registered
2007-01-17
Start date
2007-01-31
Completion date
2008-02-29
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Quantitative Sensory Testing, Neuropathy, Treatment Experienced, Treatment Naive

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.

Interventions

None listed

Sponsors

University of Medicine and Dentistry of New Jersey
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth SyndromeTests were performed during regular clinical visit. The test duration was about an hour1. 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 IntensityThe time of the examinationPain 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
HIV +
Groups divided according to CD4 counts
105
Healthy Controls
HIV -ve subjects
38
Total143

Baseline characteristics

CharacteristicHealthy ControlsTotalHIV +
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
38 Participants143 Participants105 Participants
Age, Continuous42.53 years
STANDARD_DEVIATION 12.57
45.06 years
STANDARD_DEVIATION 8.64
45.97 years
STANDARD_DEVIATION 7.22
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
35 Participants132 Participants97 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
3 Participants10 Participants7 Participants
Region of Enrollment
United States
38 participants143 participants105 participants
Sex: Female, Male
Female
14 Participants56 Participants42 Participants
Sex: Female, Male
Male
24 Participants87 Participants63 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1050 / 38
serious
Total, serious adverse events
0 / 1050 / 38

Outcome results

Primary

Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome

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.

Time frame: Tests were performed during regular clinical visit. The test duration was about an hour

Population: Comparisons of categorical variables were performed with Fischer's exact test. Trends in ordered categorical variables were tested with the chi square test.

ArmMeasureGroupValue (NUMBER)
HIV +Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth SyndromeSubjects with chronic Myogenic Pain72 Participants
HIV +Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth SyndromeSubjects with TMJ Disorder37 Participants
HIV +Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth SyndromeSubjects with Burning MouthSyndrome20 Participants
Healthy ControlsNumber of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth SyndromeSubjects with chronic Myogenic Pain8 Participants
Healthy ControlsNumber of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth SyndromeSubjects with TMJ Disorder7 Participants
Healthy ControlsNumber of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth SyndromeSubjects with Burning MouthSyndrome0 Participants
Primary

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.

Time frame: The time of the examination

Population: Comparison was made between control and HIV+ subjects

ArmMeasureGroupValue (MEAN)Dispersion
HIV +Spontaneous Pain IntensityPain in Orofacial Region2.13 units on a scale (0 to 10)Standard Deviation 2.2
HIV +Spontaneous Pain IntensityOverall body pain3.69 units on a scale (0 to 10)Standard Deviation 3.1
Healthy ControlsSpontaneous Pain IntensityPain in Orofacial Region0.05 units on a scale (0 to 10)Standard Deviation 0.3
Healthy ControlsSpontaneous Pain IntensityOverall body pain0.92 units on a scale (0 to 10)Standard Deviation 1.9
p-value: <0.05Chi-squared
p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026