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Could meditation and a simple device ease HIV nerve pain?

NCT ID NCT04868123

Symptom relief Sponsor: Rutgers University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study explores whether combining mindfulness meditation with transcutaneous nerve stimulation (TENS) can reduce foot pain in people living with HIV who have peripheral neuropathy. Participants use a home TENS device and practice guided meditation over several weeks. The goal is to see if these approaches improve pain intensity, daily function, and walking ability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous nerve stimulation (TENS) device and mindfulness meditation
What this could lead to
If it works, this could offer a simple, drug-free way to manage chronic foot pain in people living with HIV.
What could go wrong
This is a small pilot study with only 36 participants, so results may not apply broadly. Pain relief from TENS or meditation varies by person.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Apr 2022

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Pain peripheral nervous system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • Rutgers Physical Therapy Program

    Blackwood, New Jersey, 08012, United States

  • Rutgers Physical Therapy Program

    Newark, New Jersey, 07101, United States

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