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

NCT04868123 | Completed FDA Device

• 1 other identifier: Pro2020003234
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

peripheral neuropathy; pain; TENS; Mindfulness Meditation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Change from Baseline Pain Pressure Threshold at 7 weeks

  Week 0 and Week 7

• Change from Baseline Gait Characteristics at 7 weeks

  Week 0 and Week 7

• Change from Baseline Walking Endurance at 7 weeks

  Week 0 and Week 7

• Change in Baseline Physical Performance at 7 weeks

  Week 0 and Week 7

• Change from Baseline Whole Body Strength at 7 weeks

  Week 0 and Week 7

Study Arms (3)

Mindfulness Meditation

EXPERIMENTAL

6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home

Behavioral: Mindfulness Meditation

Transcutaneous nerve stimulation (TENS)

EXPERIMENTAL

6 weeks of daily TENS treatment performed at home

Device: Transcutaneous Nerve Stimulation (TENS)

Usual Care

NO INTERVENTION

Usual care (no additional treatment)

Interventions

Transcutaneous Nerve Stimulation (TENS) DEVICE

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).

Transcutaneous nerve stimulation (TENS)

Mindfulness Meditation BEHAVIORAL

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

Mindfulness Meditation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of HIV infection currently treated with antiretroviral therapy (ART)
• cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers University: lead
• Thomas Jefferson University: collaborator

Study Sites (2)

Rutgers Physical Therapy Program

Blackwood, New Jersey, 08012, United States

Location

Rutgers Physical Therapy Program

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

HIV Infections; Peripheral Nervous System Diseases; Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Mindfulness

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David M Kietrys, PhD

  Rutgers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: co-investigators involved with measurement for the interventional phase will not know which of the 3 groups a participant was randomized to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 30, 2021
• Study Start: April 22, 2022
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)