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TENS + Mindfulness Meditation for HIV-Related Pain

N/A
Waitlist Available
Led By David M Kietrys, PhD
Research Sponsored by Rutgers University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
pain in the feet present for at least the past 3 months
diagnosis of HIV infection currently treated with antiretroviral therapy (ART)
Must not have
current opportunistic infection(s)
wounds or sores on the feet
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 7
Awards & highlights
No Placebo-Only Group

Summary

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

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the trial doesn't specify side effects for TENS or mindfulness meditation, common issues might include skin irritation from TENS pads or temporary discomfort during initial stages of meditation practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had foot pain for at least 3 months.
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I am currently receiving treatment for HIV.
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I am between 18 and 64 years old.
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I experience daily foot pain of at least 3 out of 10.
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I have tingling or numbness in my feet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any current infections.
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I have wounds or sores on my feet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline Pain Intensity at 7 weeks
Change from Baseline Pain Interference at 7 weeks
Secondary study objectives
Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups)
Change from Baseline Anxiety at 7 weeks
Change from Baseline Catastrophizing Behaviors at 7 weeks
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Transcutaneous nerve stimulation (TENS)Experimental Treatment1 Intervention
6 weeks of daily TENS treatment performed at home
Group II: Mindfulness MeditationExperimental Treatment1 Intervention
6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home
Group III: Usual CareActive Control1 Intervention
Usual care (no additional treatment)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Nerve Stimulation (TENS)
2007
N/A
~120
Mindfulness Meditation
2015
Completed Phase 2
~4040

Find a Location

Who is running the clinical trial?

Rutgers UniversityLead Sponsor
118 Previous Clinical Trials
2,805,278 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
462 Previous Clinical Trials
175,502 Total Patients Enrolled
David M Kietrys, PhDPrincipal InvestigatorRutgers

Media Library

Mindfulness Meditation Clinical Trial Eligibility Overview. Trial Name: NCT04868123 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: Mindfulness Meditation, Transcutaneous nerve stimulation (TENS), Usual Care
Human Immunodeficiency Virus Infection Clinical Trial 2023: Mindfulness Meditation Highlights & Side Effects. Trial Name: NCT04868123 — N/A
Mindfulness Meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04868123 — N/A
~2 spots leftby Jan 2025
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