Study Summary
This trial is to study whether TENS and mindfulness meditation can help relieve foot pain in people living with HIV.
Treatment Effectiveness
Effectiveness Progress
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
Behavioral
Experimental Group · 1 Intervention: Mindfulness Meditation · Intervention Types: BehavioralTranscutaneous nerve stimulation (TENS)
Device
Experimental Group · 1 Intervention: Transcutaneous Nerve Stimulation (TENS) · Intervention Types: DeviceUsual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Meditation
2015
Completed Phase 2
~4040
Transcutaneous Nerve Stimulation (TENS)
2007
N/A
~120
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.
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Conditions
Cancer Related
Treatments