Trial Outcomes & Findings for Pain and Sensory Changes Assessment in HIV+ Patients (NCT NCT00422695)

Last Updated: 2017-04-13

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

143 participants

Primary outcome timeframe

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

Results posted on

2017-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	HIV + Groups divided according to CD4 counts 105 HIV subjects	Healthy Controls HIV -free subjects 38 Healthy Controls
Overall Study STARTED	105	38
Overall Study COMPLETED	105	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain and Sensory Changes Assessment in HIV+ Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV + n=105 Participants Groups divided according to CD4 counts	Healthy Controls n=38 Participants HIV -ve subjects	Total n=143 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	105 Participants n=5 Participants	38 Participants n=7 Participants	143 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.97 years STANDARD_DEVIATION 7.22 • n=5 Participants	42.53 years STANDARD_DEVIATION 12.57 • n=7 Participants	45.06 years STANDARD_DEVIATION 8.64 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	14 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	24 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	97 Participants n=5 Participants	35 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants	38 participants n=7 Participants	143 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HIV + n=105 Participants Groups divided according to CD4 counts 105 HIV subjects	Healthy Controls n=38 Participants HIV -free subjects 38 Healthy Controls
Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome Subjects with chronic Myogenic Pain	72 Participants	8 Participants
Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome Subjects with TMJ Disorder	37 Participants	7 Participants
Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome Subjects with Burning MouthSyndrome	20 Participants	0 Participants

PRIMARY outcome

Timeframe: The time of the examination

Population: Comparison was made between control and HIV+ subjects

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.

Outcome measures

Outcome measures
Measure	HIV + n=105 Participants Groups divided according to CD4 counts 105 HIV subjects	Healthy Controls n=38 Participants HIV -free subjects 38 Healthy Controls
Spontaneous Pain Intensity Pain in Orofacial Region	2.13 units on a scale (0 to 10) Standard Deviation 2.2	0.05 units on a scale (0 to 10) Standard Deviation 0.3
Spontaneous Pain Intensity Overall body pain	3.69 units on a scale (0 to 10) Standard Deviation 3.1	0.92 units on a scale (0 to 10) Standard Deviation 1.9

Adverse Events

HIV +

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eli Eliav

Rutgers School of Dental Medicine

Phone: 973 972 7210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place