Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy
- Conditions
- HIV Infections
- Interventions
- Behavioral: Mindfulness MeditationDevice: Transcutaneous Nerve Stimulation (TENS)
- Registration Number
- NCT04868123
- Lead Sponsor
- Rutgers University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- availability of a mobile phone to receive text messages over the course of the intervention period
- current opportunistic infection(s)
- cluster of differentiation 4 cell (CD4 cell) count <200 cells/mm3
- dementia
- uncontrolled psychiatric disorder
- wounds or sores on the feet
- musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness Meditation Mindfulness Meditation 6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home Transcutaneous nerve stimulation (TENS) Transcutaneous Nerve Stimulation (TENS) 6 weeks of daily TENS treatment performed at home
- Primary Outcome Measures
Name Time Method Change from Baseline Pain Intensity at 7 weeks 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 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 Outcome Measures
Name Time Method Change from Baseline Pain Pressure Threshold at 7 weeks Week 0 and Week 7 Pain pressure threshold (expressed in pounds or kilograms of force) at lower extremity landmarks via use of a digital algometer.
Change from Baseline Walking Endurance at 7 weeks Week 0 and Week 7 Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).
Change from Baseline Gait Characteristics at 7 weeks Week 0 and Week 7 Temporal and spatial characteristics of gait (walking velocity, step length, step time, stride width, cadence, foot-fall area) as captured with a ZENO instrumented walkway
Change in Baseline Physical Performance at 7 weeks Week 0 and Week 7 Physical performance score generated via the Short Physical Performance Battery. (SPPB). SPPB procedures generate a total score reflective of physical performance. Minimum score=0; maximum score=12; lower score=worse outcome.
Change from Baseline Whole Body Strength at 7 weeks Week 0 and Week 7 Mid-thigh pull test will be used to generate a score expressed as force in pounds or kilograms that is reflective of whole body strength.
Change from Baseline Catastrophizing Behaviors at 7 weeks Week 0 and Week 7 Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome.
Change from Baseline Depression at 7 weeks Week 0 and Week 7 Self-reported depression as determined by the depression subscale of the Hospital Depression and Anxiety Scale. Minimum score=0; maximum score=21; higher score=worse outcome.
Change from Baseline Physical Activity at 7 weeks Week 0 and Week 7 Physical activity characteristics: (1) over a span of 5 days captured via a wrist-band style Actigraph activity monitor, and (2) self-reported physical activity over past 7 days using the International Physical Activity Questionnaire - Short Form
Change from Baseline Mental Quality of Life (QOL) at 7 weeks Week 0 and Week 7 Mental Health Summary Score generated via responses on the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Change from Baseline Physical Quality of Life (QOL) at 7 weeks Week 0 and Week 7 Physical Health Summary Score generated via responses on the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Change from Baseline Anxiety at 7 weeks Week 0 and Week 7 Self-reported anxiety as determined by the anxiety subscale of the Hospital Depression and Anxiety Scale. Minimum score=0; maximum score=21; higher score=worse outcome.
Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups) week 6 Tracking of adherence to home based intervention (number of sessions per week completed and total number of sessions completed over 6 weeks) via direct communication with participants
Change from Baseline Resilience behaviors at 7 weeks Week 0 and Week 7 Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome.
Satisfaction with Study Experiences week 7 Self-reported satisfaction with the study parameters and study experiences using a study-specific questionnaire
Change from Baseline Pain Medication Use at 7 weeks Week 0 and Week 7 Self-report of use of pain medication base on responses to a study-specific questionnaire
Trial Locations
- Locations (1)
Rutgers Physical Therapy Program
🇺🇸Newark, New Jersey, United States