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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868123
• Other study ID #: Pro2020003234
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: David M Kietrys, PhD
• Phone: 856-566-7186
• Email: kietrydm[@]shp.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Device:
• Transcutaneous Nerve Stimulation (TENS)
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).

Behavioral:
• Mindfulness Meditation
Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.

Locations

Country	Name	City	State
United States	Rutgers Physical Therapy Program	Blackwood	New Jersey
United States	Rutgers Physical Therapy Program	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers University	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Satisfaction with Study Experiences	Self-reported satisfaction with the study parameters and study experiences using a study-specific questionnaire	week 7
Secondary	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