Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy
Last updated on July 2021Recruitment
- 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