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TENS + Mindfulness Meditation for HIV-Related Pain
Study Summary
This trial is to study whether TENS and mindfulness meditation can help relieve foot pain in people living with HIV.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I haven't used TENS or practiced mindfulness meditation in the last 6 months.You have a mental health condition that is not being managed or controlled.I do not have any current infections.You are pregnant.I haven't changed my pain management medications in the last 4 weeks.I have had foot pain for at least 3 months.I am currently receiving treatment for HIV.I am between 18 and 64 years old.I can travel to the study location.I have a condition affecting my walking, but it's not distal sensory neuropathy.I experience daily foot pain of at least 3 out of 10.You have severe memory loss and difficulty thinking clearly.I have wounds or sores on my feet.I have tingling or numbness in my feet.
- Group 1: Mindfulness Meditation
- Group 2: Transcutaneous nerve stimulation (TENS)
- Group 3: Usual Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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"
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."
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."
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."
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."
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