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Neuropathy Walks (Cross-sectional)

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Completed

Conditions

HIV Infections

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04889521
Pro2020003234(cross-sec)

Details and patient eligibility

About

Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).

Full description

The overall goal of this study is to explore the impact of HIV-associated distal sensory polyneuropathy on physical performance, physical activity, and pain pressure threshold.

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.

Enrollment

75 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diagnosis of HIV infection currently treated with antiretroviral therapy (ART)
  • 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

  • current opportunistic infection(s)
  • 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

Trial design

75 participants in 2 patient groups

HIV and painful neuropathy
Description:
Persons living with HIV who also have painful distal sensory polyneuropathy in the feet.
Treatment:
Other: No intervention
HIV without painful neuropathy
Description:
Persons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet.
Treatment:
Other: No intervention

Trial documents
2

Trial contacts and locations

2

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Central trial contact

David Kietrys, PhD

Data sourced from clinicaltrials.gov

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