Clinical trial NCT04868123: Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy
Official title: Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living With HIV-related Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: peripheral neuropathy
pain
TENS
Mindfulness Meditation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2021-04-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change from Baseline Pain Intensity at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Pain Interference at 7 weeks
timeFrame: Week 0 and Week 7
Secondary outcomes:
measure: Change from Baseline Pain Pressure Threshold at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Gait Characteristics at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Walking Endurance at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change in Baseline Physical Performance at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Whole Body Strength at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Physical Activity at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Mental Quality of Life (QOL) at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Physical Quality of Life (QOL) at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Depression at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Anxiety at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Catastrophizing Behaviors at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Resilience behaviors at 7 weeks
timeFrame: Week 0 and Week 7
measure: Change from Baseline Pain Medication Use at 7 weeks
timeFrame: Week 0 and Week 7
measure: Satisfaction with Study Experiences
timeFrame: week 7
measure: Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups)
timeFrame: week 6
Other outcomes:
Locations:
city: Blackwood
country: United States
facility: Rutgers Physical Therapy Program
state: New Jersey
city: Newark
country: United States
facility: Rutgers Physical Therapy Program
state: New Jersey
Study officials:
affiliation: Rutgers
name: David M Kietrys, PhD
role: PRINCIPAL_INVESTIGATOR
References: