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

Trial Information
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Maximum Age:
64
Healthy Volunteers:
No

• 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

Where is this trial taking place?
United States
New Jersey
Rutgers Physical Therapy Program
Recruiting
Blackwood
Rutgers Physical Therapy Program
Recruiting
Newark
Who do I contact about this trial?
Primary
David M Kietrys, PhD
kietrydm@shp.rutgers.edu
856-566-7186
When is this trial taking place?
Start Date: April 22, 2022
Estimated Completion Date: May 30, 2023
How many participants will be in this trial?
Target number of participants: 36
What treatment is being studied in this trial?
Experimental: Mindfulness Meditation
6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home
Experimental: Transcutaneous nerve stimulation (TENS)
6 weeks of daily TENS treatment performed at home
No Intervention: Usual Care
Usual care (no additional treatment)
Who are the authors of this trial?
David M Kietrys

This content was sourced from clinicaltrials.gov