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Completed

NCT Number: NCT04868123

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

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Physical Therapy Program, Blackwood, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Mindfulness Meditation

Behavioral

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

Primary outcomes

  1. Change in Pain Intensity From Baseline to 7 Weeks

    Time frame: 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.

  2. Change in Pain Interference From Baseline to 7 Weeks

    Time frame: 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.

Secondary outcomes

  1. Change in Walking Velocity From Baseline to 7 Weeks

    Time frame: 7 weeks

    a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes

  2. Change in Step Length From Baseline to 7 Weeks

    Time frame: 7 weeks

    a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes

  3. Change in Stride Width From Baseline to 7 Weeks

    Time frame: 7 weeks

    a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes

  4. Change in Cadence From Baseline to 7 Weeks

    Time frame: 7 weeks

    a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes

  5. Change in Walking Endurance From Baseline to 7 Weeks

    Time frame: 7 weeks

    Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).

  6. Change in Physical Performance (SPPB Composite Score) From Baseline to 7 Weeks

    Time frame: 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.

  7. Change in Whole Body Strength From Baseline to 7 Weeks

    Time frame: 7 weeks

    Mid-thigh pull test will be used to generate a score expressed as Newtons that is reflective of whole body strength.

  8. Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks

    Time frame: 7 weeks

    Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.

  9. Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks

    Time frame: 7 weeks

    Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.

  10. Change in Mental Quality of Life (QOL) From Baseline to 7 Weeks

    Time frame: 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.

  11. Change in Physical Quality of Life (QOL) From Baseline to 7 Weeks

    Time frame: 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.

  12. Change in Pain-Related Quality of Life From Baseline to 7 Weeks

    Time frame: 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.

  13. Change in Anxiety From Baseline to 7 Weeks

    Time frame: 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.

  14. Change in Depression From Baseline to 7 Weeks

    Time frame: 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.

  15. Change in Pain Catastrophizing From Baseline to 7 Weeks

    Time frame: 7 weeks

    Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome.

  16. Change in Resilience From Baseline to 7 Weeks

    Time frame: 7 weeks

    Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome.

  17. Adherence to Home-based Treatment Over 6 Weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rutgers University

Other

Collaborators

  • Thomas Jefferson University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2021
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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