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

Rutgers The State University of New Jersey

Status: Completed

Conditions: HIV Infections

Treatments: Device: Transcutaneous Nerve Stimulation (TENS); Behavioral: Mindfulness Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04868123

Pro2020003234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Mindfulness Meditation

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Meditation

Transcutaneous nerve stimulation (TENS)

Experimental group

Description:

6 weeks of daily TENS treatment performed at home

Treatment:

Device: Transcutaneous Nerve Stimulation (TENS)

Usual Care

No Intervention group

Description:

Usual care (no additional treatment)