Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2022-04-22
2024-09-13
Brief Summary
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Detailed Description
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The aim is to determine if the presence of painful distal sensory polyneuropathy in the feet adversely affects physical performance, physical activity, and pain pressure threshold in PLHIV.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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HIV and painful neuropathy
Persons living with HIV who also have painful distal sensory polyneuropathy in the feet.
No intervention
No intervention. Study is cross-sectional observational.
HIV without painful neuropathy
Persons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet.
No intervention
No intervention. Study is cross-sectional observational.
Interventions
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No intervention
No intervention. Study is cross-sectional observational.
Eligibility Criteria
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Inclusion Criteria
* cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3
* 18-64 years of age
* able to read and write in English
* means to travel to a study site
* Additional inclusion for cohort with painful neuropathy in the feet:
* presence of peripheral neuropathy symptoms in feet
* average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale
* pain in the feet present for at least the past 3 months
* no changes in medications used to manage pain in the past 4 weeks
Exclusion Criteria
* cluster of differentiation 4 cell (CD4 cell) count \<200 cells/mm3
* dementia
* uncontrolled psychiatric disorder
* wounds or sores on the feet
* musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait
* pregnancy
18 Years
89 Years
ALL
No
Sponsors
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Thomas Jefferson University
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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David Kietrys
Associate Professor
Principal Investigators
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David Kietrys, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers School of Health Professions
Locations
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Rutgers Physical Therapy Program
Blackwood, New Jersey, United States
Rutgers Physical Therapy Program
Newark, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro2020003234(cross-sec)
Identifier Type: -
Identifier Source: org_study_id
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