Status:
COMPLETED
Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy
Lead Sponsor:
Rutgers University
Collaborating Sponsors:
Thomas Jefferson University
Conditions:
HIV Infections
Eligibility:
All Genders
18-89 years
Phase:
NA
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 perso...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04868123
Start Date
April 22 2022
End Date
January 7 2025
Last Update
March 7 2025
Active Locations (2)
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1
Rutgers Physical Therapy Program
Blackwood, New Jersey, United States, 08012
2
Rutgers Physical Therapy Program
Newark, New Jersey, United States, 07101