CompletedNot Applicable

Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy

United States36 participantsStarted 2022-04-22

Plain-language 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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pain Intensity From Baseline to 7 Weeks

Timeframe: 7 weeks

Change in Pain Interference From Baseline to 7 Weeks

Timeframe: 7 weeks

Trial details

NCT IDNCT04868123

SponsorRutgers University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-07

Results submitted2026-01-16

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.