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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
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).
Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.
Rutgers Physical Therapy Program
Blackwood, New Jersey, United States
Rutgers Physical Therapy Program
Newark, New Jersey, United States
Change in Pain Intensity From Baseline to 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. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.
Time frame: 7 weeks
Change in Pain Interference From Baseline to 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. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.
Time frame: 7 weeks
Change in Walking Velocity From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Time frame: 7 weeks
Change in Step Length From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Time frame: 7 weeks
Change in Stride Width From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Time frame: 7 weeks
Change in Cadence From Baseline to 7 Weeks
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Time frame: 7 weeks
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Change in Walking Endurance From Baseline to 7 Weeks
Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).
Time frame: 7 weeks
Change in Physical Performance (SPPB Composite Score) From Baseline to 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.
Time frame: 7 weeks
Change in Whole Body Strength From Baseline to 7 Weeks
Mid-thigh pull test will be used to generate a score expressed as Newtons that is reflective of whole body strength.
Time frame: 7 weeks
Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks
Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.
Time frame: 7 weeks
Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks
Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.
Time frame: 7 weeks
Change in Mental Quality of Life (QOL) From Baseline to 7 Weeks
Mental health QOL subscale from the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Time frame: 7 weeks
Change in Physical Quality of Life (QOL) From Baseline to 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.
Time frame: 7 weeks
Change in Pain-Related Quality of Life From Baseline to 7 Weeks
Pain-related QOL subscale score generated via responses on the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Time frame: 7 weeks
Change in Anxiety From Baseline to 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.
Time frame: 7 weeks
Change in Depression From Baseline to 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.
Time frame: 7 weeks
Change in Pain Catastrophizing From Baseline to 7 Weeks
Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome.
Time frame: 7 weeks
Change in Resilience From Baseline to 7 Weeks
Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome.
Time frame: 7 weeks
Adherence to Home-based Treatment Over 6 Weeks
Adherence to home based intervention is defined as total number of treatment sessions completed over 6 weeks via direct communication with participants
Time frame: over 6 weeks