← Back to Search

TENS + Mindfulness Meditation for HIV-Related Pain

N/A
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 7
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have had foot pain for at least 3 months.
Select...
I am currently receiving treatment for HIV.
Select...
I am between 18 and 64 years old.
Select...
I experience daily foot pain of at least 3 out of 10.
Select...
I have tingling or numbness in 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline Pain Intensity at 7 weeks
Change from Baseline Pain Interference at 7 weeks
Secondary outcome measures
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

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
2017
Completed Phase 2
~4780

Find a Location

Who is running the clinical trial?

Rutgers UniversityLead Sponsor
113 Previous Clinical Trials
2,804,057 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
445 Previous Clinical Trials
145,453 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be considered an ideal candidate to take part in this clinical research?

"Currently, this clinical trial is seeking 36 HIV-positive individuals between 18 and 89 years old. In order to qualify, applicants must demonstrate the capacity for literacy in English, existing evidence of peripheral neuropathy within their feet; with an accompanying CD4 cell count of no less than 200 cells/mm3 minimum. Furthermore they should have been exposed to ART treatment, possess a viable means of transportation to a study site; report average daily pain scores at 3 or above on the 0-10 numerical scale over the past three months, not undergone any alterations in pain management regimens inside the last 4 weeks; abstained from using either TENS machines"

Answered by AI

What are the aspirations of this research endeavor?

"This clinical trial's principal outcome to be evaluated over a Week 0 and Week 7 timeline is Pain Interference Change from Baseline at 7 weeks. Other objectives include assessing Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups) which will rely on direct communication with participants, Physical Activity Change from Baseline at 7 weeks which involve the use of an Actigraph activity monitor and International Physical Activity Questionnaire - Short Form, as well as Pain Medication Use Change from Baseline at 7 weeks by way of study-specific questionnaires."

Answered by AI

Are participants above 45 years of age eligible for this trial?

"The minimum age requirement to join this study is 18, while the maximum age limit is 89. There are 108 trials available for those below the legal voting age and 352 specifically targeting seniors over 65 years old."

Answered by AI

Are there still vacancies open for participants in this research?

"The information hosted on clinicaltrials.gov suggests that this trial is still recruiting participants, beginning with the initial posting date of April 22nd 2022, and most recently updated on July 25th 2022."

Answered by AI

What is the current capacity for participants in this clinical trial?

"Affirmative. Per the clinicaltrials.gov listing, this experiment is actively recruiting participants as of July 25th 2022 after first being posted on April 22nd 2022. Two medical sites are needed to enrol 36 patients in total."

Answered by AI
~0 spots leftby Apr 2024