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Pain and Sensory Changes Assessment in HIV+ Patients

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ClinicalTrials.gov Identifier: NCT00422695
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV Infections
Enrollment 143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV + Healthy Controls
Hide Arm/Group Description Groups divided according to CD4 counts 105 HIV subjects HIV -free subjects 38 Healthy Controls
Period Title: Overall Study
Started 105 38
Completed 105 38
Not Completed 0 0
Arm/Group Title HIV + Healthy Controls Total
Hide Arm/Group Description Groups divided according to CD4 counts HIV -ve subjects Total of all reporting groups
Overall Number of Baseline Participants 105 38 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 38 participants 143 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
105
 100.0%
38
 100.0%
143
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 38 participants 143 participants
45.97  (7.22) 42.53  (12.57) 45.06  (8.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 38 participants 143 participants
Female
42
  40.0%
14
  36.8%
56
  39.2%
Male
63
  60.0%
24
  63.2%
87
  60.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 38 participants 143 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
97
  92.4%
35
  92.1%
132
  92.3%
White
7
   6.7%
3
   7.9%
10
   7.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.0%
0
   0.0%
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 105 participants 38 participants 143 participants
105 38 143
1.Primary Outcome
Title Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome
Hide Description
  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
Hide Outcome Measure Data
Hide Analysis Population Description
Comparisons of categorical variables were performed with Fischer’s exact test. Trends in ordered categorical variables were tested with the chi square test.
Arm/Group Title HIV + Healthy Controls
Hide Arm/Group Description:
Groups divided according to CD4 counts 105 HIV subjects
HIV -free subjects 38 Healthy Controls
Overall Number of Participants Analyzed 105 38
Measure Type: Number
Unit of Measure: Participants
Subjects with chronic Myogenic Pain 72 8
Subjects with TMJ Disorder 37 7
Subjects with Burning MouthSyndrome 20 0
2.Primary Outcome
Title Spontaneous Pain Intensity
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison was made between control and HIV+ subjects
Arm/Group Title HIV + Healthy Controls
Hide Arm/Group Description:
Groups divided according to CD4 counts 105 HIV subjects
HIV -free subjects 38 Healthy Controls
Overall Number of Participants Analyzed 105 38
Mean (Standard Deviation)
Unit of Measure: units on a scale (0 to 10)
Pain in Orofacial Region 2.13  (2.2) 0.05  (0.3)
Overall body pain 3.69  (3.1) 0.92  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV +, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV +, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Adverse events were assessed during the examination. The patients were patients of records and were routinely examined in the clinic.
Adverse Event Reporting Description No interventional procedures were made
 
Arm/Group Title HIV + Healthy Controls
Hide Arm/Group Description Groups divided according to CD4 counts 105 HIV subjects HIV -free subjects 38 Healthy Controls
All-Cause Mortality
HIV + Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIV + Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/105 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV + Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/105 (0.00%)   0/38 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Eli Eliav
Organization: Rutgers School of Dental Medicine
Phone: 973 972 7210
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00422695     History of Changes
Other Study ID Numbers: 0120060172
First Submitted: January 16, 2007
First Posted: January 17, 2007
Results First Submitted: March 9, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017