TENS + Mindfulness Meditation for HIV-Related Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how transcutaneous nerve stimulation (TENS) and mindfulness meditation can reduce foot pain caused by nerve damage in people living with HIV. It will compare three groups: one using mindfulness meditation, another using TENS, and a third continuing their usual care without these treatments. Individuals who have been on HIV treatment with foot pain for at least three months and have not tried TENS or mindfulness meditation in the last six months might be suitable candidates.
As an unphased trial, this study provides a unique opportunity to explore new methods for managing foot pain and improving quality of life.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it requires no changes in pain management medications in the past 4 weeks. This suggests you may need to continue your current pain medications without changes.
What prior data suggests that transcutaneous nerve stimulation (TENS) and mindfulness meditation are safe for persons living with HIV?
Earlier studies have found that mindfulness meditation can help reduce stress and improve overall well-being. Research shows that mindfulness usually doesn't cause harmful side effects. Instead, it often lowers stress indicators like blood pressure and cortisol, a stress hormone.
For transcutaneous nerve stimulation (TENS), studies show mixed results. Some people find TENS helpful for pain relief, but little evidence supports its effectiveness specifically for HIV-related pain. Importantly, TENS is generally considered safe. It rarely causes serious side effects, though some people might experience mild skin irritation where the electrodes are placed.
Both treatments appear well-tolerated, with mindfulness meditation being particularly low-risk.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer non-drug alternatives for managing HIV-related pain. Mindfulness meditation involves practicing daily guided sessions at home, which can help reduce stress and improve overall well-being without any medication. Transcutaneous nerve stimulation (TENS) is another intriguing option, using a device that delivers mild electrical impulses to the skin, potentially blocking pain signals and offering relief. Both methods provide a fresh approach compared to traditional pain medications, which often come with side effects and the risk of dependency. These treatments empower patients to manage their pain independently, which could be a game-changer for those living with HIV.
What evidence suggests that TENS and mindfulness meditation could be effective for HIV-related pain?
Research has shown that mindfulness meditation, one of the treatments in this trial, can help reduce pain and stress. In one study, participants who practiced mindfulness experienced less pain and continued to feel better months later. Another study found that mindfulness lowered stress and depression over eight weeks.
For transcutaneous nerve stimulation (TENS), another treatment option in this trial, research results are mixed. Some studies suggest TENS can reduce pain immediately after use without major side effects. However, other studies are less clear about its long-term effectiveness for nerve-related pain. Overall, both treatments seem promising, but their effectiveness can vary from person to person.46789Who Is on the Research Team?
David M Kietrys, PhD
Principal Investigator
Rutgers
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either mindfulness meditation or TENS treatment at home for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mindfulness Meditation
- Transcutaneous Nerve Stimulation (TENS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers University
Lead Sponsor
Thomas Jefferson University
Collaborator