Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868123
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2021-04-25
Brief Title:
Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy
Sponsor:
Rutgers University
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation TENS in Persons Living With HIV-related Peripheral Neuropathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None