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

Last updated: March 4, 2025
Sponsor: Rutgers University
Overall Status: Completed

Phase

N/A

Condition

Hiv Infections

Treatment

Transcutaneous Nerve Stimulation (TENS)

Mindfulness Meditation

Clinical Study ID

NCT04868123
Pro2020003234
  • Ages 18-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

  • presence of peripheral neuropathy symptoms in feet

  • average daily self-reported pain in the feet of at least 3/10 on a 0-10 numericalpain 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 theintervention period

Exclusion

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

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Transcutaneous Nerve Stimulation (TENS)
Phase:
Study Start date:
April 22, 2022
Estimated Completion Date:
January 07, 2025

Study 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.

Connect with a study center

  • Rutgers Physical Therapy Program

    Blackwood, New Jersey 08012
    United States

    Site Not Available

  • Rutgers Physical Therapy Program

    Newark, New Jersey 07101
    United States

    Site Not Available

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