TENS + Mindfulness Meditation for HIV-Related Pain

Recruiting at 1 trial location

Overseen By David M Kietrys, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers University

Must be taking: Antiretroviral therapy

Disqualifiers: Opportunistic infection, Dementia, Uncontrolled psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David M Kietrys, PhD

Principal Investigator

Rutgers

Eligibility Criteria

This trial is for adults aged 18-64 with HIV who are on antiretroviral therapy, have a CD4 cell count of at least 200 cells/mm3, and suffer from painful neuropathy in their feet. Participants must not have changed pain medications recently, be able to use a mobile phone, read/write English, and travel to the study site. They should not have used TENS or mindfulness meditation recently.

Inclusion Criteria

I haven't used TENS or practiced mindfulness meditation in the last 6 months.

availability of a mobile phone to receive text messages over the course of the intervention period

I haven't changed my pain management medications in the last 4 weeks.

Exclusion Criteria

cluster of differentiation 4 cell (CD4 cell) count <200 cells/mm3

You have a mental health condition that is not being managed or controlled.

I do not have any current infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mindfulness meditation or TENS treatment at home for 6 weeks

6 weeks

Home-based intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person or virtual)

Treatment Details

Interventions

• Mindfulness Meditation
• Transcutaneous Nerve Stimulation (TENS)

Trial Overview The study investigates how transcutaneous nerve stimulation (TENS) and mindfulness meditation help manage foot neuropathy pain in people living with HIV. It aims to see if these treatments can reduce discomfort associated with neuropathy.

Participant Groups

Group I: Transcutaneous nerve stimulation (TENS) Experimental Treatment 1 Intervention

6 weeks of daily TENS treatment performed at home

Group II: Mindfulness Meditation Experimental Treatment 1 Intervention

6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home

Group III: Usual Care Active Control 1 Intervention

Usual care (no additional treatment)

Who Is Running the Clinical Trial?

Rutgers University

Lead Sponsor

Trials

127

Recruited

2,814,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+