Transcutaneous Nerve Stimulation (TENS) for Human Immunodeficiency Virus (HIV) Infection

Phase-Based Progress Estimates
Human Immunodeficiency Virus (HIV) InfectionTranscutaneous Nerve Stimulation (TENS) - Device
18 - 89
All Sexes
What conditions do you have?

Study Summary

This trial is to study whether TENS and mindfulness meditation can help relieve foot pain in people living with HIV.

Treatment Effectiveness

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: week 7

Week 7
Change from Baseline Anxiety at 7 weeks
Change from Baseline Catastrophizing Behaviors at 7 weeks
Mental Depression
Change from Baseline Gait Characteristics at 7 weeks
Change from Baseline Mental Quality of Life (QOL) at 7 weeks
Change from Baseline Pain Intensity at 7 weeks
Change from Baseline Pain Interference at 7 weeks
Change from Baseline Pain Medication Use at 7 weeks
Change from Baseline Pain Pressure Threshold at 7 weeks
Change from Baseline Physical Activity at 7 weeks
Change from Baseline Physical Quality of Life (QOL) at 7 weeks
Change from Baseline Resilience behaviors at 7 weeks
Change from Baseline Walking Endurance at 7 weeks
Change from Baseline Whole Body Strength at 7 weeks
Change in Baseline Physical Performance at 7 weeks
week 6
Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups)
week 7
Satisfaction with Study Experiences

Trial Safety

Trial Design

3 Treatment Groups

Usual Care
1 of 3
Mindfulness Meditation
1 of 3
Transcutaneous nerve stimulation (TENS)
1 of 3

Active Control

Experimental Treatment

36 Total Participants · 3 Treatment Groups

Primary Treatment: Transcutaneous Nerve Stimulation (TENS) · No Placebo Group · N/A

Mindfulness Meditation
Experimental Group · 1 Intervention: Mindfulness Meditation · Intervention Types: Behavioral
Transcutaneous nerve stimulation (TENS)
Experimental Group · 1 Intervention: Transcutaneous Nerve Stimulation (TENS) · Intervention Types: Device
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Meditation
Completed Phase 2
Transcutaneous Nerve Stimulation (TENS)

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 7

Who is running the clinical trial?

Rutgers UniversityLead Sponsor
98 Previous Clinical Trials
1,240,196 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
407 Previous Clinical Trials
135,469 Total Patients Enrolled
David M Kietrys, PhDPrincipal InvestigatorRutgers

Eligibility Criteria

Age 18 - 89 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have HIV infection currently treated with antiretroviral therapy (ART).
CD4 cell count of at least 200 cells/mm3.
You are between the ages of 18 and 64 years.
You are able to travel to a study site.\n
You have pain in your feet that is worse than normal and is affecting your daily life.
You have pain in the feet for at least the past 3 months.
You have not taken any changes in medications used to manage pain in the past 4 weeks.
You have not used TENS or mindfulness meditation in the prior 6 months.