NCT04868123

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

Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living With HIV-related Peripheral Neuropathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Rutgers University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DEVICE	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).
BEHAVIORAL	Mindfulness Meditation	Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.

Timeline

• Start date: 2022-04-22
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2021-04-30
• Last updated: 2025-03-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study