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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2025-01-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

co-investigators involved with measurement for the interventional phase will not know which of the 3 groups a participant was randomized to

Study Groups

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Mindfulness Meditation

6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.

Transcutaneous nerve stimulation (TENS)

6 weeks of daily TENS treatment performed at home

Group Type EXPERIMENTAL

Transcutaneous Nerve Stimulation (TENS)

Intervention Type DEVICE

Transcutaneous nerve stimulation (TENS) is a simple home base treatment to manage pain. It involves electrical current applied to the skin through self-adhering electrodes, using a TENS3000 device (TENSPros.com).

Usual Care

Usual care (no additional treatment)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transcutaneous Nerve Stimulation (TENS)

Transcutaneous nerve stimulation (TENS) is a simple home base treatment to manage pain. It involves electrical current applied to the skin through self-adhering electrodes, using a TENS3000 device (TENSPros.com).

Intervention Type DEVICE

Mindfulness Meditation

Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No