Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
72

Summary

Conditions
HIV Infections
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)Masking: Single (Outcomes Assessor)Masking Description: co-investigators involved with measurement for the interventional phase will not know which of the 3 groups a participant was randomized toPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 64 years
Gender
Both males and females

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 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.

Tracking Information

NCT #
NCT04868123
Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: David M Kietrys, PhD Rutgers