Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living With HIV-related Peripheral Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Rutgers University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change from Baseline Pain Intensity at 7 weeks
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study is to explore the effects of transcutaneous nerve stimulation (TENS) and mindfulness meditation in persons living with HIV (PLHIV) and painful neuropathy in the feet.
Detailed Description
The overall goal of this study is to conduct an interventional pilot trial of mindfulness meditation and transcutaneous nerve stimulation (TENS) to mitigate the symptoms and improved function in persons living with HIV (PLHIV) and painful neuropathy in the feet. . The investigators aim to determine the feasibility and effects of (1) mindfulness meditation or (2) transcutaneous nerve stimulation (TENS) on clinical and functional outcomes in participants with HIV-associated painful distal sensory polyneuropathy in the feet. This aim will be achieved with a randomized control pilot trial with 3 groups: TENS group, Mindfulness Mediation Group, and Usual Treatment (Control) group. The interventions will be performed at home over a period of 6 weeks.
Investigators
David Kietrys
Associate Professor
Rutgers, The State University of New Jersey
Eligibility Criteria
Inclusion Criteria
- •diagnosis of HIV infection currently treated with antiretroviral therapy (ART)
- •cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3
- •18-64 years of age
- •able to read and write in English
- •means to travel to a study site
- •presence of peripheral neuropathy symptoms in feet
- •average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale
- •pain in the feet present for at least the past 3 months
- •no changes in medications used to manage pain in the past 4 weeks
- •no use of TENS or mindfulness meditation in the prior 6 months
Exclusion Criteria
- •current opportunistic infection(s)
- •cluster of differentiation 4 cell (CD4 cell) count \<200 cells/mm3
- •uncontrolled psychiatric disorder
- •wounds or sores on the feet
- •musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait
- •pregnancy
Outcomes
Primary Outcomes
Change from Baseline Pain Intensity at 7 weeks
Time Frame: Week 0 and Week 7
Responses to questions on the Brief Pain Inventory Pain Intensity subscale used to generate pain intensity score. Minimum score=0; maximum score=10; higher score=worse outcome.
Change from Baseline Pain Interference at 7 weeks
Time Frame: Week 0 and Week 7
Responses to questions on the Brief Pain Inventory Pain Interference subscale used to generate pain interference score. Minimum score=0; maximum score=10; higher score=worse outcome.
Secondary Outcomes
- Change from Baseline Pain Pressure Threshold at 7 weeks(Week 0 and Week 7)
- Change from Baseline Walking Endurance at 7 weeks(Week 0 and Week 7)
- Change from Baseline Gait Characteristics at 7 weeks(Week 0 and Week 7)
- Change from Baseline Physical Quality of Life (QOL) at 7 weeks(Week 0 and Week 7)
- Change from Baseline Anxiety at 7 weeks(Week 0 and Week 7)
- Change in Baseline Physical Performance at 7 weeks(Week 0 and Week 7)
- Change from Baseline Whole Body Strength at 7 weeks(Week 0 and Week 7)
- Change from Baseline Catastrophizing Behaviors at 7 weeks(Week 0 and Week 7)
- Change from Baseline Depression at 7 weeks(Week 0 and Week 7)
- Change from Baseline Physical Activity at 7 weeks(Week 0 and Week 7)
- Change from Baseline Mental Quality of Life (QOL) at 7 weeks(Week 0 and Week 7)
- Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups)(week 6)
- Change from Baseline Resilience behaviors at 7 weeks(Week 0 and Week 7)
- Satisfaction with Study Experiences(week 7)
- Change from Baseline Pain Medication Use at 7 weeks(Week 0 and Week 7)