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

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Nerve Stimulation (TENS)
Mindfulness Meditation
Sponsored by
Rutgers University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring peripheral neuropathy, pain, TENS, Mindfulness Meditation

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Physical Therapy ProgramRecruiting
  • Rutgers Physical Therapy ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Mindfulness Meditation

Transcutaneous nerve stimulation (TENS)

Usual Care

Arm Description

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

6 weeks of daily TENS treatment performed at home

Usual care (no additional treatment)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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).
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.
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.
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
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.
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.
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.
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.
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.
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.
Change from Baseline Pain Medication Use at 7 weeks
Self-report of use of pain medication base on responses to a study-specific questionnaire
Satisfaction with Study Experiences
Self-reported satisfaction with the study parameters and study experiences using a study-specific questionnaire
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

Full Information

First Posted
April 25, 2021
Last Updated
August 18, 2023
Sponsor
Rutgers University
Collaborators
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04868123
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
Collaborators
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
peripheral neuropathy, pain, TENS, Mindfulness Meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)
Masking
Outcomes Assessor
Masking Description
co-investigators involved with measurement for the interventional phase will not know which of the 3 groups a participant was randomized to
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Meditation
Arm Type
Experimental
Arm Description
6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home
Arm Title
Transcutaneous nerve stimulation (TENS)
Arm Type
Experimental
Arm Description
6 weeks of daily TENS treatment performed at home
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care (no additional treatment)
Intervention Type
Device
Intervention Name(s)
Transcutaneous Nerve Stimulation (TENS)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation
Intervention Description
Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.
Primary Outcome Measure Information:
Title
Change from Baseline Pain Intensity at 7 weeks
Description
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.
Time Frame
Week 0 and Week 7
Title
Change from Baseline Pain Interference at 7 weeks
Description
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.
Time Frame
Week 0 and Week 7
Secondary Outcome Measure Information:
Title
Change from Baseline Pain Pressure Threshold at 7 weeks
Description
Pain pressure threshold (expressed in pounds or kilograms of force) at lower extremity landmarks via use of a digital algometer.
Time Frame
Week 0 and Week 7
Title
Change from Baseline Gait Characteristics at 7 weeks
Description
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
Time Frame
Week 0 and Week 7
Title
Change from Baseline Walking Endurance at 7 weeks
Description
Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).
Time Frame
Week 0 and Week 7
Title
Change in Baseline Physical Performance at 7 weeks
Description
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
Week 0 and Week 7
Title
Change from Baseline Whole Body Strength at 7 weeks
Description
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.
Time Frame
Week 0 and Week 7
Title
Change from Baseline Physical Activity at 7 weeks
Description
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
Time Frame
Week 0 and Week 7
Title
Change from Baseline Mental Quality of Life (QOL) at 7 weeks
Description
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.
Time Frame
Week 0 and Week 7
Title
Change from Baseline Physical Quality of Life (QOL) at 7 weeks
Description
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
Week 0 and Week 7
Title
Change from Baseline Depression at 7 weeks
Description
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
Week 0 and Week 7
Title
Change from Baseline Anxiety at 7 weeks
Description
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
Week 0 and Week 7
Title
Change from Baseline Catastrophizing Behaviors at 7 weeks
Description
Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome.
Time Frame
Week 0 and Week 7
Title
Change from Baseline Resilience behaviors at 7 weeks
Description
Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome.
Time Frame
Week 0 and Week 7
Title
Change from Baseline Pain Medication Use at 7 weeks
Description
Self-report of use of pain medication base on responses to a study-specific questionnaire
Time Frame
Week 0 and Week 7
Title
Satisfaction with Study Experiences
Description
Self-reported satisfaction with the study parameters and study experiences using a study-specific questionnaire
Time Frame
week 7
Title
Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups)
Description
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
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M Kietrys, PhD
Phone
856-566-7186
Email
kietrydm@shp.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Kietrys, PhD
Organizational Affiliation
Rutgers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Physical Therapy Program
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kietrys, PhD
Phone
856-566-7186
Email
kietrydm@shp.rutgers.edu
Facility Name
Rutgers Physical Therapy Program
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kietrys, PhD
Phone
856-566-7186
Email
kietrydm@shp.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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