HIV InfectionsNCT04868123

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

A study testing Transcutaneous Nerve Stimulation (TENS) and Mindfulness Meditation in people with HIV Infections, run by Rutgers University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: HIV Infections
What is being tested?: Transcutaneous Nerve Stimulation (TENS) and Mindfulness Meditation
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 2 sitesUnited States
Study dates: 22 Apr 2022to 7 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Rutgers Physical Therapy Program
Blackwood, New Jersey, 08012
Rutgers Physical Therapy Program
Newark, New Jersey, 07101

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: HIV Infections
Being tested: Transcutaneous Nerve Stimulation (TENS), Mindfulness Meditation
Keywords: peripheral neuropathy, pain, TENS, Mindfulness Meditation
Medical subject headings: HIV Infections, Peripheral Nervous System Diseases, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Nerve Stimulation (TENS)Device
Transcutaneous nerve stimulation (TENS) is a simple home base treatment to manage pain. It involves electrical current applied to the skin through self-adhering electrodes, using a TENS3000 device (TENSPros.com).
Mindfulness MeditationBehavioural
Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.

Study groups in NCT04868123
Study group	Role	What they receive
Mindfulness Meditation	Experimental	6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home Receives: Behavioral: Mindfulness Meditation
Transcutaneous nerve stimulation (TENS)	Experimental	6 weeks of daily TENS treatment performed at home Receives: Device: Transcutaneous Nerve Stimulation (TENS)
Usual Care	No intervention	Usual care (no additional treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Intensity From Baseline to 7 Weeks
Responses to questions on the Brief Pain Inventory Pain Intensity subscale used to generate pain intensity score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.
Measured: 7 weeks
Change in Pain Interference From Baseline to 7 Weeks
Responses to questions on the Brief Pain Inventory Pain Interference subscale used to generate pain interference score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.
Measured: 7 weeks

Secondary outcomes (17)

Change in Walking Velocity From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Measured: 7 weeks
Change in Step Length From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Measured: 7 weeks
Change in Stride Width From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Measured: 7 weeks
Change in Cadence From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Measured: 7 weeks
Change in Walking Endurance From Baseline to 7 Weeks
Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).
Measured: 7 weeks
Change in Physical Performance (SPPB Composite Score) From Baseline to 7 Weeks
Physical performance score generated via the Short Physical Performance Battery. (SPPB). SPPB procedures generate a total score reflective of physical performance. Minimum score=0; maximum score=12; lower score=worse outcome.
Measured: 7 weeks
Change in Whole Body Strength From Baseline to 7 Weeks
Mid-thigh pull test will be used to generate a score expressed as Newtons that is reflective of whole body strength.
Measured: 7 weeks
Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks
Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.
Measured: 7 weeks
Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks
Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.
Measured: 7 weeks
Change in Mental Quality of Life (QOL) From Baseline to 7 Weeks
Mental health QOL subscale from the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Measured: 7 weeks
Change in Physical Quality of Life (QOL) From Baseline to 7 Weeks
Physical Health Summary Score generated via responses on the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Measured: 7 weeks
Change in Pain-Related Quality of Life From Baseline to 7 Weeks
Pain-related QOL subscale score generated via responses on the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Measured: 7 weeks
Change in Anxiety From Baseline to 7 Weeks
Self-reported anxiety as determined by the anxiety subscale of the Hospital Depression and Anxiety Scale. Minimum score=0; maximum score=21; higher score=worse outcome.
Measured: 7 weeks
Change in Depression From Baseline to 7 Weeks
Self-reported depression as determined by the depression subscale of the Hospital Depression and Anxiety Scale. Minimum score=0; maximum score=21; higher score=worse outcome.
Measured: 7 weeks
Change in Pain Catastrophizing From Baseline to 7 Weeks
Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome.
Measured: 7 weeks
Change in Resilience From Baseline to 7 Weeks
Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome.
Measured: 7 weeks
Adherence to Home-based Treatment Over 6 Weeks
Adherence to home based intervention is defined as total number of treatment sessions completed over 6 weeks via direct communication with participants
Measured: over 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 20227 Jan 2025

First posted30 Apr 2021
Study start22 Apr 2022
Primary completion7 Jan 2025
Study completion7 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04868123
Sponsor's protocol ID: Pro2020003234
Status last verified: Jun 2026
First submitted: 25 Apr 2021
Last updated: 8 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living With HIV-related Peripheral Neuropathy
ClinicalTrials.gov ID: NCT04868123
Acronym / sponsor ID: Pro2020003234
Conditions: HIV Infections
Keywords: peripheral neuropathy, pain, TENS, Mindfulness Meditation
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Rutgers UniversityUniversity, hospital or other
Collaborators: Thomas Jefferson University
Study start: 22 Apr 2022 (actual)
Primary completion: 7 Jan 2025 (actual)
Study completion: 7 Jan 2025 (actual)
First posted: 30 Apr 2021 (actual)
Results: Posted 8 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)

Arm	Type	Receives
Mindfulness Meditation	Experimental	Behavioral: Mindfulness Meditation6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home
Transcutaneous nerve stimulation (TENS)	Experimental	Device: Transcutaneous Nerve Stimulation (TENS)6 weeks of daily TENS treatment performed at home
Usual Care	No intervention	–Usual care (no additional treatment)

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcutaneous Nerve Stimulation (TENS)Transcutaneous nerve stimulation (TENS) is a simple home base treatment to manage pain. It involves electrical current applied to the skin through self-adhering electrodes, using a TENS3000 device (TENSPros.com).	Device	Transcutaneous nerve stimulation (TENS)
Mindfulness MeditationMindfulness mediation is a guided mediation process to improve awareness of being present in the moment.	Behavioural	Mindfulness Meditation

Primary outcome

Change in Pain Intensity From Baseline to 7 Weeks
Time frame: 7 weeks
Responses to questions on the Brief Pain Inventory Pain Intensity subscale used to generate pain intensity score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.
Change in Pain Interference From Baseline to 7 Weeks
Time frame: 7 weeks
Responses to questions on the Brief Pain Inventory Pain Interference subscale used to generate pain interference score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.

17 secondary outcomes

Change in Walking Velocity From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Step Length From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Stride Width From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Cadence From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Walking Endurance From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Physical Performance (SPPB Composite Score) From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Whole Body Strength From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Mental Quality of Life (QOL) From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Physical Quality of Life (QOL) From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Pain-Related Quality of Life From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Anxiety From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Depression From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Pain Catastrophizing From Baseline to 7 Weeks
Time frame: 7 weeks
Change in Resilience From Baseline to 7 Weeks
Time frame: 7 weeks
Adherence to Home-based Treatment Over 6 Weeks
Time frame: over 6 weeks

Results and safety

Results posted to the registry on 8 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness Meditation	12	10
Transcutaneous Nerve Stimulation (TENS)	12	8
Usual Care	12	11

Primary outcome: Change in Pain Intensity From Baseline to 7 Weeks

Time frame: 7 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Mindfulness Meditation n = 10	Transcutaneous Nerve Stimulation (TENS) n = 8	Usual Care n = 11
Value	-0.8 (1.4)	0.3 (1.9)	-0.5 (1.9)

Mindfulness Meditation vs Transcutaneous Nerve Stimulation (TENS) vs Usual Care: Wald Chi2 (DF=5): 6.71, p >.05, Mixed Models Analysis
Transcutaneous Nerve Stimulation (TENS) vs Usual Care: Mean Difference (Net): .660 (95% CI -1.09 to 2.41), p = 0.459, Mixed Models Analysis
Mindfulness Meditation vs Usual Care: Mean Difference (Net): -.304 (95% CI -1.71 to 1.10), p = 0.671, Mixed Models Analysis

Primary outcome: Change in Pain Interference From Baseline to 7 Weeks

Time frame: 7 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Mindfulness Meditation n = 10	Transcutaneous Nerve Stimulation (TENS) n = 8	Usual Care n = 11
Value	0.1 (3.5)	0.2 (2.8)	-0.1 (3.1)

Mindfulness Meditation vs Usual Care: Mean Difference (Net): -.043 (95% CI -2.67 to 2.58), p = 0.975, Mixed Models Analysis
Transcutaneous Nerve Stimulation (TENS) vs Usual Care: Mean Difference (Net): .114 (95% CI -2.44 to 2.67), p = 0.931, Mixed Models Analysis

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 7 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness Meditation	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Transcutaneous Nerve Stimulation (TENS)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Usual Care	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David M Kietrys, PhD principal investigator

Rutgers

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Nerve Stimulation (TENS) and Mindfulness Meditation in people with HIV Infections, run by Rutgers University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity From Baseline to 7 Weeks (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04868123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.