N/A
N=143
Pain and Sensory Changes Assessment in HIV+ Patients
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00422695 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome — 72; 8; 37; 7 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Medicine and Dentistry of New Jersey
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome |
72; 8; 37; 7; 20; 0 | — |
| PRIMARY Spontaneous Pain Intensity |
2.13; 0.05; 3.69; 0.92 | <0.05 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00422695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.