Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living With HIV-related Peripheral Neuropathy

Conditions
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HIV Infections

Intervention / Treatment
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* Device: Transcutaneous Nerve Stimulation (TENS)
* Behavioral: Mindfulness Meditation


Participation Criteria
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Eligibility Criteria
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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 availability of a mobile phone to receive text messages over the course of the intervention period Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation<br>6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home | Behavioral: Mindfulness Meditation<br>* Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.<br>|
| Experimental: Transcutaneous nerve stimulation (TENS)<br>6 weeks of daily TENS treatment performed at home | Device: Transcutaneous Nerve Stimulation (TENS)<br>* Transcutaneous nerve stimulation (TENS) is a simple home base treatment to manage pain. It involves electrical current applied to the skin through self-adhering electrodes, using a TENS3000 device (TENSPros.com).<br>|
| No Intervention: Usual Care<br>Usual care (no additional treatment) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain Intensity at 7 weeks | 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. | Week 0 and Week 7 | 
| Change from Baseline Pain Interference at 7 weeks | 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. | Week 0 and Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain Pressure Threshold at 7 weeks | Pain pressure threshold (expressed in pounds or kilograms of force) at lower extremity landmarks via use of a digital algometer. | Week 0 and Week 7 | 
| Change from Baseline Gait Characteristics at 7 weeks | 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 | Week 0 and Week 7 | 
| Change from Baseline Walking Endurance at 7 weeks | Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes). | Week 0 and Week 7 | 
| Change in Baseline Physical Performance at 7 weeks | 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. | Week 0 and Week 7 | 
| Change from Baseline Whole Body Strength at 7 weeks | 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. | Week 0 and Week 7 | 
| Change from Baseline Physical Activity at 7 weeks | 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 | Week 0 and Week 7 | 
| Change from Baseline Mental Quality of Life (QOL) at 7 weeks | 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. | Week 0 and Week 7 | 
| Change from Baseline Physical Quality of Life (QOL) at 7 weeks | 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. | Week 0 and Week 7 | 
| Change from Baseline Depression at 7 weeks | 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. | Week 0 and Week 7 | 
| Change from Baseline Anxiety at 7 weeks | 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. | Week 0 and Week 7 | 
| Change from Baseline Catastrophizing Behaviors at 7 weeks | Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome. | Week 0 and Week 7 | 
| Change from Baseline Resilience behaviors at 7 weeks | Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome. | Week 0 and Week 7 | 
| Change from Baseline Pain Medication Use at 7 weeks | Self-report of use of pain medication base on responses to a study-specific questionnaire | Week 0 and Week 7 | 
| Satisfaction with Study Experiences | Self-reported satisfaction with the study parameters and study experiences using a study-specific questionnaire | week 7 | 
| Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups) | 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 | week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral neuropathy, pain, TENS, Mindfulness Meditation