Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy

  • STATUS
    Recruiting
  • End date
    May 30, 2023
  • participants needed
    36
  • sponsor
    Rutgers University
Updated on 4 October 2022
antiretroviral
antiretroviral therapy

Summary

This study is to explore the effects of transcutaneous nerve stimulation (TENS) and mindfulness meditation in persons living with HIV (PLHIV) and painful neuropathy in the feet.

Description

The overall goal of this study is to conduct an interventional pilot trial of mindfulness meditation and transcutaneous nerve stimulation (TENS) to mitigate the symptoms and improved function in persons living with HIV (PLHIV) and painful neuropathy in the feet. .

The investigators aim to determine the feasibility and effects of (1) mindfulness meditation or (2) transcutaneous nerve stimulation (TENS) on clinical and functional outcomes in participants with HIV-associated painful distal sensory polyneuropathy in the feet. This aim will be achieved with a randomized control pilot trial with 3 groups: TENS group, Mindfulness Mediation Group, and Usual Treatment (Control) group. The interventions will be performed at home over a period of 6 weeks.

Details
Condition HIV Infections
Treatment Mindfulness Meditation, Transcutaneous Nerve Stimulation (TENS)
Clinical Study IdentifierNCT04868123
SponsorRutgers University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
-64 years of age
able to read and write in English
means to travel to a study site
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
no use of TENS or mindfulness meditation in the prior 6 months
availability of a mobile phone to receive text messages over the course of the intervention period

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
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