Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living With HIV-related Peripheral Neuropathy
Phase: NA
Conditions: HIV Infections
Sponsor: Rutgers University

NCT04868123 
 
 
Title of Study: Impact of Distal Sensory Polyneuropathy on Function in Persons Living with HIV and a 
Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living 
with HIV-related Peripheral Neuropathy   
(Brief Title: Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy)   
 
Document Date: 3.1.2024 (PROTOCOL-SAP) 

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Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
t 
INTERVENTIONAL
RESEARCH PROTOCOL TEMPLATE
(HRP-503a)  
STUDY INFORMATION

Title of Project: Impact of Distal Sensory Polyneuropathy on Function in Persons 
Living with HIV and a Pilot Study of Mindfulness Meditation and Transcutaneous 
Nerve Stimulation (TENS) in Persons Living with HIV-related Peripheral Neuropathy

Principal Investigator Name: David Kietrys, PT, PhD, FCPP

Principal Investigator Div. & Dept.:  RBHS School of Health Professions – 
Department of Rehabilitation and Movement Sciences

Principal Investigator Contact Info: 
kietrydm@shp.rutgers.edu 
 
65 Bergen St. #714C
Newark, NJ 07107
856-566-7186

Protocol Version and Date:       v10.0   3.1.2024     
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Table of Contents
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue
1.0
Research Design
1.1
Purpose/Specific Aims
1.2
Research Significance
1.3
Research Design and Methods
1.4
Preliminary Data
1.5
Sample Size Justification
1.6
Study Variables
1.7
Drugs/Devices/Biologics
1.8
Specimen Collection
1.9
Data Collection
1.10
Timetable/Schedule of Events
2.0
Project Management
2.1
Research Staff and Qualifications
2.2
Research Staff Training
2.3
Resources Available
2.4
Research Sites
3.0
Multi-Center Research
4.0
Subject Considerations
4.1
Subject Selection and Enrollment Considerations
4.2
Secondary Subjects
4.3
Number of Subjects
4.4
Consent Procedures
4.5
Special Consent Populations
4.6
Economic Burden and/or Compensation For Subjects
4.7
Risks of Harm/Potential for Benefits to Subjects to Subjects
5.0
Special Considerations
5.1
Health Insurance Portability and Accountability Act (HIPAA)
5.2
Family Educational Rights and Privacy Act (FERPA)
5.3
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
5.4
General Data Protection Regulation (GDPR)
5.5
 NJ Access to Medical Research Act (Surrogate Consent) 
6.0
Data Management Plan
6.1
Data Analysis
6.2
Data Security
6.3
Data Safety And Monitoring
6.4
Reporting Results
6.5
Secondary Use of the Data
7.0
Research Repositories – Specimens and/or Data
8.0
Approvals/Authorizations
9.0
Bibliography
1.0 Research Design
1.1 Purpose/Specific Aims
The overall goal of this study is to explore the impact of HIV-associated distal sensory 
polyneuropathy on function, physical activity and pain pressure threshold, and conduct an 
interventional pilot trial of mindfulness meditation and transcutaneous nerve stimulation (TENS) to 
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mitigate symptoms and improve function in persons living with HIV-related distal sensory 
neuropathy (DSP).
A.  Objectives 
Aim 1. Determine if the presence of painful distal sensory polyneuropathy in the feet adversely 
affects function (gait and physical performance), physical activity, and pain pressure threshold in 
persons living with HIV (PLHIV).  (From this point forward, protocol related to Aim 1 will be 
referred to as “cross-sectional phase”)
Aim 2. Determine the feasibility and effects of (1) mindfulness meditation or (2) transcutaneous 
nerve stimulation (TENS) on clinical and functional outcomes in persons with HIV-associated 
painful distal sensory polyneuropathy in the feet.  (From this point forward, protocol related to Aim 
1 will be referred to as “interventional phase”) 
.
B.  Hypotheses / Research Question(s)
Hypothesis for Aim 1 (cross-sectional phase): Temporal and spatial characteristics of gait, 
walking endurance, physical performance scores and pain pressure threshold scores will be 
worse, and physical activity will be lower, in those with DSP than in those without DSP.
Hypothesis for Aim 2 (interventional phase): There will be a beneficial effect on all clinical and 
functional outcomes in each of the 2 intervention groups (mindfulness meditation; TENS) 
compared to a standard care group.   
1.2 Research Significance
       Anti-retroviral therapy (ART) has increased longevity of PLHIV. However, comorbidities and disability 
may emerge over time.1-3 Chronic pain is common, with prevalence of 39-85%.4-10 Chronic pain in PLHIV 
has a multifactorial etiology.11,12 It is associated with increased odds of impaired mobility, self-care, usual 
activities, and disability.13-16 In middle aged and older PLHIV, pain is associated with frailty.17,18
       Distal sensory polyneuropathy (DSP) is a common neurological complication of HIV disease, with 
prevalence exceeding 40%.19-21 The etiology is related to HIV-infection, associated metabolic changes, 
mitochondrial dysfunction, and neurotoxic effects of ART.20,22-24 Risk factors include older age, lower CD4 
nadir, and exposure to certain antiretroviral drugs.20,25-27 Symptoms include impaired sensation, 
paresthesia, diminished reflexes, and pain. In PLHIV and DSP, the prevalence of chronic neuropathic 
pain is 54-78%.25,28-30  We have found that DSP is associated with worse quality of life, poorer lower 
extremity function, and more severe disability,14,31 and that disability associated with DSP in PLHIV is 
mediated through pain and depression.32 Other studies have reported associations between DSP and 
sleep disturbance, interference with activities and emotions, and greater levels of catastrophizing and 
depression.33-35 Although impairments of gait and balance have been identified in PLHIV36, it remains 
unclear if DSP further affects gait and physical performance.  
       Management of pain in PLHIV and DSP can include pharmaceutical approaches37, but their 
effectiveness is uncertain.38 Opioids have poor efficacy for management of chronic pain.39 The literature 
on non-pharmaceutical management of DSP in PLHIV is limited to 2 trials of night splints40 and exercise41 
and a small number of pilot or case studies that have explored yoga, electrical stimulation, or a 
combination of manual therapy, electrical stimulation, stretching, and self-management.42-45 
       Mindfulness meditation has been used to reduce stress and symptoms in people with chronic 
diseases, including HIV.46 The practice involves bringing one’s attention to experiences in the present 
moment.47 Mindfulness has been shown to reduce ART side-effects, enhance quality of life, improve 
emotional status, and improve CD4 cell count in PLHIV.48-51 It has not been specifically studied for 
management of chronic pain in PLHIV and DSP.  
       Conventional TENS involves low-voltage current applied to the skin  for pain relief.52  High frequency 
TENS is recommended for patients who are taking opioid pain medication.53 TENS has been widely 
studied in patients with chronic pain, although its effectiveness remains uncertain.54,55 In patients with 
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diabetic neuropathy, studies have reported that TENS is effective for reduction in neuropathic 
symptoms.56 Other than a double case study using micro-current TENS (a specific form that is not widely 
used)43, TENS has not been studied in PLHIV and DSP.  
       DSP is associated with a wide array of impairments and limitations in PLHIV, but the study of non-
pharmaceutical intervention strategies has been sparse.  Mindfulness mediation and conventional TENS 
have not been studied in this population. Current gaps in knowledge include quantification of whether 
DSP in PLHIV adversely affects gait, balance, physical performance, and physical activity, and 
identification of interventions to improve clinical outcomes.   
1.3 Research Design and Methods
This study will include a cross-sectional phase for Aim 1, and an interventional phase with 3 arms for Aim 
2.  All enrolled participants (those with DSP and those without DSP) will be involved with the cross-sectional 
phase for Aim 1.  Only participants with DSP and foot pain will continue on into the interventional phase for 
Aim 2. Data will be collected via an array of non-invasive tests and questionnaires that will be administered 
a members of the study team. All data except for gait and walking endurance will be collected in a private 
room. Gait and walking endurance measurements will be conducted in a room of adequate size for this, or 
in a nearby unobstructed hallway.   
A.
Research Procedures
Procedure
(in order of 
occurrence)
When
Where
By Whom
Recruitment of 
Participants
Cross-sectional phase 
and interventional phase
May 2022-June 2024
various HIV treatment 
centers in the NJ region 
and/or HIV support groups
Dave Kietrys 
Judith Barberio
Shobha 
Swaminathan
 
Oonagh Breen
Screening for Eligibility
Cross-sectional phase 
and interventional phase
May 2022–June 
2024
By phone or HIPAA 
compliant ZOOM meeting
Dave Kietrys 
 
Oonagh Breen
Consenting 
Cross-sectional phase 
and interventional phase 
May 2022–June 
2024
Rutgers study site 
(in Newark or Voorhees) or 
Wm Way Center in 
Philadelphia 
Dave Kietrys 
 
Oonagh Breen 
Baseline Testing     
(Week 0)
Cross-sectional phase 
and interventional phase
May 2022–June 
2024
Rutgers study site 
(in Newark or Voorhees) or 
Wm Way Center in 
Philadelphia for in-person 
tests and questionnaires
Physical activity monitoring 
done at home 
Dave Kietrys
Richard Ferraro
Andrew Lynch
 
Oonagh Breen
Group assignment and 
instruction in 
interventions for TENS 
and MM groups 
Interventional phase only
May 2022–June 
2024
Rutgers study site 
(in Newark or Voorhees) or 
Wm Way Center in 
Philadelphia 
Dave Kietrys 
Andrew Lynch
 
 
Oonagh Breen
Home-based 
Interventions and daily 
May 2022–July  2024
Participant’s home  
Participant
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question re: adherence 
via text message
(6 weeks)
Interventional phase only
Post-intervention 
Testing 
(Week 7) 
Interventional phase only
May 2022–July  2024
Rutgers study site 
(in Newark or Voorhees) or 
Wm. Way Center in  
Philadelphia
for in-person tests and 
questionnaires 
Physical activity monitoring 
done at home  
Dave Kietrys
Richard Ferraro
Andrew Lynch
 
Oonagh Breen 
Follow up 
Questionnaire 
(Week 15) 
Interventional Phase 
only for those who 
were in TENS or MM 
groups and enrolled 
after IRB approval to add 
follow up questionnaire. 
April 2024 – Sept.  
2024 
Paticipant’s home or 
location of choice via 
Email/RedCap 
David Kietrys 
Procedures to monitor subjects for safety and minimize risk of harm during testing: Study 
staff will follow CDC and Rutgers COVID precautions that are in place at the time (such as 
wearing a face mask and a face shield) throughout the testing session.  Study staff will wash their 
hands before and after a testing session and sanitize their hands frequently throughout a testing 
session. All equipment including pens or iPads used for questionnaires will be disinfected both 
prior to and immediately following a testing session for a given participant. Participants will be 
scheduled one at a time with no overlap. If more than one participant is scheduled on the same 
day, there will be a full hour gap between participants to allow time for disinfection of all testing 
equipment. Participants’ appointments will be postponed if they are experiencing symptoms of 
COVID-19 or are febrile or had a high risk exposure to a COVID infected individual during the 
week prior to their testing appointment. This will be determined by the PI or study staff calling the 
participant the day prior to or the morning of their appointment.  Prior to testing procedures, 
participants’ resting heart rate, blood pressure, respiratory rate and temperature will be taken. If 
vital signs values or temperature are outside of acceptable ranges, testing will not proceed on 
that date. All participants will be required to follow COVID precautions that are in place at the time 
of testing throughout the testing session. Currently, this includes participants wearing masks 
throughout the session, sanitizing their hands with hand sanitizer prior to the start of testing and 
prior to leaving the testing session, and maintaining social distance of at least 6’ between study 
team personnel and participants will be maintained except for when testing procedures require 
closer proximity. All participants will be guided by and supervised by a study team member 
throughout all testing procedures. During the balance tests that are included the Short Physical 
Performance Battery, the PI or his designated study team member will stand adjacent to the 
participant and provide guarding in case the participants experience a loss of balance. The other 
test that will require proximity of less than 6’ is pain pressure threshold testing. After each test, 
participants will be asked if they would like to sit and rest before continuing on to the next test. If 
participants appear to be in any distress or become lightheaded during testing, they will be given 
the option of lying down on a treatment table or sitting in a chair, and their vital signs will be 
reassessed. 
Procedures to monitor subjects for safety and minimize risk of harm during the period of 
home-based interventions: Participants in the interventional phase will be notified on baseline 
testing day that they should contact the PI if any problems arise during the 6 week at-home 
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intervention period. Participants in the TENS will be educated on how to inspect their skin after 
removing electrodes following a TENS treatment. Because DSP typically causes impaired 
sensation in the distal extremities TENS electrodes will not be placed on the feet. Rather, the 
locations will be more proximal at designated points on the lower extremities that have been 
assessed (on the day of baseline testing) by study personnel to have protective sensation as 
assessed with a 5.07 gauge (10 gram) Semmes-Weinstein monofilament. Participants in the 
TENS group who do not have protective sensation over the TENS sites in the legs will NOT be 
provided with TENS treatment. In addition, participants will be contacted once a week by text 
message meeting and will be asked if they are experiencing any problems of difficulties with the 
home-based interventions.  
Randomization: The cross-sectional phase does not require randomization. For the 
interventional phase, participants with DSP will be randomly assigned to either the TENS group 
or the MM group or the standard care group (SC) using a web-based random number generator 
(https://www.randomizer.org/) that will link a group code (TENS, MM, or SC) to a participant’s 
study ID number. Once a participant has been randomized to a group, the matching of the 
participant’s ID number and assigned group will be delivered a study team member in a sealed 
opaque envelope. 
B.
Data Points
Data elements include an array of non-invasive physical performance tests, physical activity 
monitoring, pain pressure threshold testing, and questionnaires.   See Section 1.6 B. for detail on 
dependent variables/outcome measures.
The data elements will be collected at baseline (Week 0) for all participants.  
At Week 0, all participants complete a demographic and health questionnaire and  a physical 
activity questionnaire, the Brief Pain Inventory,  and will undergo testing related to gait, walking 
endurance, physical performance, and pain-pressure threshold. They will receive a physical 
activity monitor that they will be asked to wear for 5 days and then ship back to the PI in a pre-
paid shipping box. 
Those with DSP-related pain will also complete questionnaires for pain, quality of life,   
depression and anxiety, catastrophizing behavior, and resilience at Week 0. 
Those participants with DSP-related pain will be randomized to continue on to the interventional 
phase. Throughout the 6-week intervention period, participants in the TENS and MM groups will 
receive a daily text message in the morning that will ask them if they completed the home-based 
treatment on the day prior, and a weekly text message to ask if any problems have emerged; 
participants in the standard care group will receive a weekly text message to ask if any problems 
have emerged. All participants in the interventional phase will return for follow up testing after 6 
weeks of intervention (Week 7), at which time all measurements taken at Week 0 will be 
repeated.   In addition, participants will complete a satisfaction questionnaire at Week 7. They will 
once again receive a physical activity monitor that they will be asked to wear for 5 days and then 
ship back to the PI in a pre-paid shipping box. In addition, those who were randomized to the 
TENS or MM groups starting in March 2024 will complete a short follow up questionnaire at Week 
15. 
C.
Study Duration
72-80 participants will be seen one time for testing, followed by 5 days of physical activity 
monitoring for the cross-sectional phase.  
The 36-40 participants without DSP will be engage for approximately one week (baseline testing 
followed by 5 days of activity monitoring). 
The 36-40 participants with DSP-related pain will continue with the interventional phase for 6 
weeks (home-based treatment or usual care/control) then return for post-intervention testing at 
week 7, followed by 5 days of activity monitoring. At week 15, those who were randomized to the 
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TENS or MM groups will receive a short follow-up questionnaire via email/RedCap. Overall, those 
with DSP (interventional phase) will be participating for approximately 8 weeks if in the Usual 
Care Group, or 15 weeks if in the TENS or MM groups (to account for the follow up 
questionnaire). 
The overall duration of the study is expected to be 12 months. Participants will be enrolled on a 
rolling basis as determined by their available for test dates and times.  
D.
Endpoints
Study end point for those participants without DSP (cross-sectional phase only) will be 5 days 
after the date of a participant’s on-site baseline testing. (Following on-site baseline testing, they 
will continue to wear an activity monitor for 5 days). Study end point for those participants with 
DSP and randomized to the Usual Care group will be approximately 8 weeks from the date of on-
site baseline testing, allowing for 5 days of activity monitoring after on-site base line testing, 6 
weeks of home based intervention, on-site post-intervention testing, and 5 days of activity 
monitoring after the on-site post-intervention testing. Study end point for those participants with 
DSP and randomized to the TENS or MM groups will be approximately 15 weeks from the date of 
on-site baseline testing, allowing for 5 days of activity monitoring after on-site base line testing, 6 
weeks of home based intervention, on-site post-intervention testing, 5 days of activity monitoring 
after the on-site post-intervention testing, and finally a follow up questionnaire at week 15. All test 
procedures are expected to safe.  However, any participants who report increase physical or 
emotional distress during testing will be invited to rest so that study staff can reassess their vital 
signs and determine if the participant can continue if they choose to do so. Testing procedures 
will cease if a participant falls or sustains any form of injury during the testing. 
Although the interventions (TENS, mindfulness meditation) pose negligible risk, if a participant 
experiences a serious adverse event, that participant will be withdrawn from the study. Any 
adverse events will be reported to the IRB.  Furthermore, participants can elect to withdraw 
themselves from the study at any time. 
1.4 Preliminary Data
There is no preliminary data; this is a new study. This interventional phase of this study will be used to 
generate data on the feasibility and effect sizes of the interventions that will be used for future projects. 
1.5 Sample Size Justification
A sample of 80 participants will be enrolled in the cross sectional phase and 40 participants (those 
with DSP) will continue on to the interventional phase. 
The target sample size of 72 (36 with DSP and 36 without DSP) for the cross sectional phase is 
adequate to explore of between group differences in gait, physical performance, physical activity, and 
pain pressure threshold variables.  For the interventional phase, 36 participants (12 participants in 
each of the 3 groups) is adequate to demonstrate feasibility and determine effect sizes that can 
inform a future randomized controlled trial. The expected accrual rate is 90% (drop-out rate of <10%); 
thus, the number enrolled will be 80. 
1.6 Study Variables
A.   Independent Variables, Interventions, or Predictor Variables 
For the cross-sectional phase of the study, gait, physical performance, physical activity, pain 
severity, pain interference,  and pain pressure threshold will be compared between those that 
have painful distal sensory polyneuropathy and those who do not. See 1.6 B. for a detailed list of 
variables. 
The interventional phase will include 3 treatment groups: transcutaneous nerve stimulation 
(TENS), mindfulness meditation (MM), and a standard care group (SC). TENS and MM will 
involve commonly used standards and are not experimental.   
TENS: TENS settings (frequency, pulse width, and mode) will be set by the investigator prior to 
giving the unit to the participants. Participants in the TENS group will receive a new battery-
operated hand-held TENS300 device (TENSpros.com, St. Louis, MO), 6 sets of electrodes 
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(TENSpros.com, St. Louis, MO), six 9-volt batteries, and an instruction manual. After the 5th day 
of baseline physical activity monitoring, they will be provided with a link to a 10-minute 
instructional video. A dual channel setup will be utilized to deliver one channel to each lower 
extremity at sites proximal to the feet that have been determined to have protective sensation 
with at 5.07 gauge (10 gram) Semmes-Weinstein monofilament. Standard settings for chronic 
pain will be used.  Patients will be instructed in how to apply 2”X2” self-adhering electrodes to the 
designated points on the lower extremities, how to control the intensity, and how to change the 
battery if needed.  They will be advised to self-administer TENS once a day for 30 minutes. 
Instructions provided to participants will include that they should adjust the intensity of the TENS 
at the start of the session and again after 15 minutes, as follows: “Turn the intensity dial up to the 
point where the electrical stimulation feeling is unpleasant or painful, then immediately turn it 
down just slightly to just below that” and, “after 15 minutes, turn up the intensity dial more to point 
where is it unpleasant or painful, then turn it down just slightly below that”. If participants lose or 
damage their TENS unit, it will promptly be replaced with a new unit.         
Mindfulness Meditation (MM):  After the 5th day of baseline physical activity monitoring, 
participants in the MM group will sent a link to view a 10-minute orientation video.. Participants in 
the MM group will be instructed to complete a 15-30-minute meditation every day. The 
meditations will be guided by pre-recorded audios, with a different theme each week. Participants 
will receive a link to the pre-recorded audios by text message and/or email.     
Standard care group:  Participants in the standard care group will be advised to continue with 
their current pain management strategies and continue to see any health care providers that they 
normally see.  Following 5 days of activity tracing (after their return for data collection at W7), 
TENS and MM will be offered to them at no cost. If they accept the offer of TENS, they will 
receive the same equipment and instruction that was provided to those in the TENS group. If they 
accept the offer of MM, they will be provided with links to the orientation video and the meditation 
audio recordings.  
B.  Dependent Variables or Outcome Measures 
Type of Variable 
Measurement  Instrument
Cross-sectional phase 
Week 0 
(all participants)
Temporal and spatial characteristics of 
gait (walking velocity; step length; step 
time; stride width; cadence; footfall 
area)
Zeno instrumented walkway with 
PKMAS gait analysis software 
(Protokinetics Inc., Havertown, PA)
Walking endurance 
6-Minute Walk Test
Physical performance   
Short Physical Performance Battery
Whole body strength
Mid-thigh Pull test
Pain pressure threshold
Digital Algometer (JTech Medical, 
Midvale, UT)
Physical activity over 5 days
Physical activity past week 
Actigraph wGT3X-BT  device 
(Actigraph, Pensacola, FL) 
International Physical Activity 
Questionnaire Short-Form (IPAQ-
SF) 
  
Pain severity
Pain interference
Brief Pain Inventory 
Interventional phase 
Week 0
(only those participants 
 
Quality of life
 
Medical Outcomes Study HIV 
Health Survey (MOS-HIV)
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Depression and/or Anxiety  
Hospital Anxiety and Depression 
Scale (HADS)
Catastrophizing behaviors
Pain Catastrophizing Scale
Resilience 
6-item Brief Resilience Scale 
with DSP-related pain)  
Note: variables 
measured for cross-
sectional phase will also 
be used as outcomes for 
interventional phase
Self-reported use of pain medication
Pain management questionnaire  
Interventional phase
Weeks 1-6
(only those participants 
with DSP-related pain)  
Adherence to home-intervention 
protocol (fidelity) 
  
Participant responses to daily text 
messages
All variables as listed for Week 0
(including those used in cross-
sectional phase) 
As listed for Week 0
(including those used in cross-
sectional phase)
Interventional phase  
Week 7
(only those participants 
with DSP-related pain)  
Satisfaction
(Week 7 only)
Post-intervention Satisfaction 
Questionnaire   
Interventional phase
Week 15 
(only for those 
participants with DSP-
related pain who were 
randomized to the TENS 
or MM groups) 
Ongoing use of interventions
Follow up Questionnaire  
1.7 Drugs/Devices/Biologics:  Not applicable 
A.
Drug/Device Accountability and Storage Methods: Not applicable 
1.8 Specimen Collection
A.
Primary Specimen Collection: Not applicable
B.
Secondary Specimen Collection: Not applicable 
1.9 Data Collection
A.
Primary Data Collection

Locations:
o
Rutgers SHP site:  200 College Drive, Jefferson Hall #317, Blackwood, NJ.  This site 
is a lab housed in the program of the PI (Kietrys) and thus no special permission is 
needed.
o
Rutgers SHP site: 65 Bergen St., #214, Newark NJ.  This site is a lab housed in the 
department of PI (Kietrys) and thus no special permission is needed. 
o
William Way LGBT Community Center, Philadelphia PA  
o
Jefferson Health, 400 Laurel Oak Road, Voorhees, NJ
o
Broadway House, 298 Broadway, Newark, NJ 

Process of Data Collection:   
Data
How it will be collected
Who will oversee the 
process 
Demographic and health 
information
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys 
Rich Ferraro
Andrew Lynch
 
 
Oonagh Breen
Zeno instrumented walkway 
with PKMAS gait analysis 
On-site using portable 
equipment (Zeno 
Dave Kietrys 
Richard Ferraro
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software (Protokinetics Inc., 
Havertown, PA)
instrumented walkway) and 
laptop computer. 
Andrew Lynch
 
 
Oonagh Breen
6-Minute Walk Test
On-site using space in the lab 
or hallway that is clear. 
Dave Kietrys 
Richard Ferraro
Andrew Lynch 
 
 
Oonagh Breen
Actigraph GT3X-BT  device  
with ActiLife software 
(Actigraph, Pensacola, FL) 
While on–site, participant will 
receive instruction in use of 
Actigraph device. After the 
participant receives 
instruction in use of the 
device, they will be wear it for 
5 days, then ship it back to 
the PI in a pre-paid shipping 
box. 
Data from the participant will 
be downloaded into a laptop 
computer before the device is 
wiped of date, disinfected, 
and prepared to use with a 
different participant. 
Dave Kietrys 
  
International Physical Activity 
Questionnaire Short-Form 
(IPAQ-SF)
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys 
Andrew Lynch 
 
Rich Ferraro
 
Oonagh Breen 
Short Physical Performance 
Battery
On-site, using portable 
equipment (chair, stopwatch)
Dave Kietrys 
Richard Ferraro
Andrew Lynch
 
 
Oonagh Breen
Mid-thigh Pull 
  
On-site, using portable 
equipment (load cell platform)
Dave Kietrys 
Richard Ferraro
Andrew Lynch
 
 
Oonagh Breen 
Digital Algometer (JTech 
Medical, Midvale, UT)
On-site, using portable digital 
algometer
Dave Kietrys 
Richard Ferraro
Andrew Lynch 
 
 
Oonagh Breen
Brief Pain Inventory
Questionnaire 
Dave Kietrys 
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
(web-based using RedCap)
Completed on-site  
Andrew Lynch 
 
Rich Ferraro
 
Oonagh Breen
Medical Outcomes Study HIV 
Health Survey (MOS-HIV)
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys 
Andrew Lynch 
 
Rich Ferraro
 
Oonagh Breen 
Hospital Depression and 
Anxiety Scale (HADS)
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys 
Andrew Lynch 
 
Rich Ferraro
 
Oonagh Breen
Pain Catastrophizing Scale
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys 
Andrew Lynch 
 
Rich Ferraro
 
Oonagh Breen
Pain management  
questionnaire  
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys 
Andrew Lynch 
 
Rich Ferraro 
 
Oonagh Breen
Brief Resilience Scale
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys
Andrew Lynch  
 
Rich Ferraro
 
Oonagh Breen 
Tracking of adherence to 
home-based treatment 
Participant responses to daily 
text message from a study-
specific Twilio account. 
Dave Kietrys 
Andrew Lynch 
 
 
 
Satisfaction questionnaire   
Questionnaire 
(web-based using RedCap)
Completed on-site  
Dave Kietrys 
Andrew Lynch 
 
Rich Ferraro
 
Oonagh Breen 
Follow up questionnaire (for  
those who were in TENS and 
MM groups)
Questionnaire
(web-based using RedCap)   
Completed at participant’s 
home or location of their 
choice. 
David Kietrys 
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      

Timing and Frequency:   
Cross-sectional phase: All participants will be seen individually at Week 0 (baseline) for all 
variables included in the cross-sectional study. In addition, participants will wear an activity 
monitor for 5 days following the baseline session. 
Interventional phase. Participants who continue on into the interventional phase (those with 
DSP) will complete additional questionnaires at Week 0 and then will be seen again at Week 7 
(following 6 weeks of home-based intervention or usual care).  In addition, participants will 
wear an activity monitor for 5 days following the Week 7 session.
At Week 0, the expected time to complete all data collection for those participants without 
DSP is 45 minutes (gait and physical performance tests) and the expected time for those 
participants with DSP is 1.5 hours (45 minutes for gait and physical performance tests and 45 
minutes for questionnaires.) 
At Week 7, the expected time to complete all data collection is 1.5 hours (45 minutes for gait 
and physical performance tests and 45 minutes for questionnaires.) 
At week 15, participants who were randomized to the TENS and MM groups will receive a 
short follow-up questionnaire (5-10 minutes to complete) 

Procedures for Audio/Visual Recording: Not applicable.  

Study Instruments:   
Instrument 
Details
References to support Validity and 
Reliability 
Zeno 
instrumented 
walkway  
Instrumented walkways are 
widely used to collect gait 
data. The walkway is a 15’ flat 
mat placed on for floor.  The 
mat is placed along the loop 
used for the 6-minute walk test 
(described below). Data from 
the 3 laps during the 6-minute 
walk test will be used. 
Participants are instructed to 
walk at their natural pace.  
Vallabhajosula, et al. (2019). Concurrent 
validity of the Zeno walkway for measuring 
spatiotemporal gait parameters in older 
adults. Journal of Geriatric Physical 
Therapy, 42(3), E42-E50.
Lynall, R. C., Zukowski, L. A., Plummer, P., 
& Mihalik, J. P. (2017). Reliability and 
validity of the protokinetics movement 
analysis software in measuring center of 
pressure during walking. Gait & 
Posture, 52, 308-311.
6-Minute Walk 
Test
A 60’ loop is marked on the 
floor with traffic cones. 
Participants are instructed to 
walk at their natural pace.   
Over 6 minutes of walking, the 
number of completed laps are 
counted. A rolling 
measurement wheel is used to 
measure the distance walked 
during the final lap (if not full) 
at 6 minutes.  
ATS statement: guidelines for the six-
minute walk test. (2002). ATS committee on 
proficiency standards for clinical pulmonary 
function laboratories. Am J Respir Crit Care 
Med, 166(1), 111-117.
Perera, S., Mody, S. H., Woodman, R. C., 
& Studenski, S. A. (2006). Meaningful 
change and responsiveness in common 
physical performance measures in older 
adults. Journal of the American Geriatrics 
Society, 54(5), 743-749..
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
Actigraph 
wGT3X-BT  
device  
The Actigraph device 
resembles a watch. It is worn 
around the wrist. It should be 
worn continuously during the 
prescribed 5-day period except 
for when it is removed for re-
charging. 
Acebo, C., & LeBourgeois, M. K. (2006). 
Actigraphy. Respiratory Care Clinics of 
North America, 12(1), 23-30.
Aadland, E., & Ylvisåker, E. (2015). 
Reliability of the Actigraph GT3X+ 
accelerometer in adults under free-living 
conditions. PloS One, 10(8), e0134606.
International 
Physical Activity 
Questionnaire 
Short-Form 
(IPAQ-SF)
Questionnaire, self-report 
estimate of physical activity 
over past 7 days
Lee, P. H., Macfarlane, D. J., Lam, T. H., & 
Stewart, S. M. (2011). Validity of the 
international physical activity questionnaire 
short form (IPAQ-SF): A systematic 
review. International journal of behavioral 
nutrition and physical activity, 8(1), 1-11.
Craig, C., Marshall, A., Sjostrom, M., Bauman, 
A., Lee, P., Macfarlane, D., ... & Stewart, S. 
(2017). International physical activity 
questionnaire-short form. J Am Coll 
Health, 65(7), 492-501.
Short Physical 
Performance 
Battery (SPPB)
The SPPB includes 3 tests:
Balance tests that involved 
timed standing (up to 10 sec. 
each) in side-by-side standing, 
semi-tandem standing and 
tandem standing.
Gait speed over a 4-meter 
distance is calculated. 
Timed 5 time-sit-to-stand test. 
The participant rises from 
sitting a chair 5 times. 
Mijnarends, D. M., Meijers, J. M., Halfens, 
R. J., ter Borg, S., Luiking, Y. C., Verlaan, 
S., ... & Schols, J. M. (2013). Validity and 
reliability of tools to measure muscle mass, 
strength, and physical performance in 
community-dwelling older people: a 
systematic review. Journal of the American 
Medical Directors Association, 14(3), 170-
178.
Westman, A. W., Combs-Miller, S., Moore, 
J., & Ehrlich-Jones, L. (2019). 
Measurement characteristics and clinical 
utility of the short physical performance 
battery among community-dwelling older 
adults. Archives of Physical Medicine and 
Rehabilitation, 100(1), 185-187.
Mid-thigh Pull 
The participant stands on a 
testing platform with hips and 
knees slightly bent, and holds   
a handle bar that is connected 
to the platform via a chain and 
linked to a force gauge.  The 
participant is instructed to pull 
up on the bar with maximum 
effort for 5 seconds. This is 
repeated 3 times and the 
maximum value is recorded. 
The test serves as an indicator 
of total body strength.   
Comfort, P., Dos' Santos, T., Beckham, G. 
K., Stone, M. H., Guppy, S. N., & Haff, G. 
G. (2019). Standardization and 
methodological considerations for the 
isometric midthigh pull. Strength & 
Conditioning Journal, 41(2), 57-79.
Brady, C. J., Harrison, A. J., & Comyns, T. 
M. (2018). A review of the reliability of 
biomechanical variables produced during 
the isometric mid-thigh pull and isometric 
squat and the reporting of normative 
data. Sports Biomechanics, 19(1), 1-25.
Digital 
Algometer  
The blunt tip of the algometer 
is placed along the dorsal 
web-space (between 1st and 
2nd toes) or the  proximal 
Vaughan, B., McLaughlin, P., & Gosling, C. 
(2007). Validity of an electronic pressure 
algometer. International Journal of 
Osteopathic Medicine, 10(1), 24-28.
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
lateral tibia just below the 
lateral tibial plateau. Pressure 
is slowly increased until 
subject reports it is painful, 
after which the pressure is 
removed. The value 
(threshold) is recorded.   
Vaughan, B., McLaughlin, P., & Gosling, C. 
(2007). Validity of an electronic pressure 
algometer. International Journal of 
Osteopathic Medicine, 10(1), 24-28.
Brief Pain 
Inventory
Questionnaire, subscale 
scores for Pain Intensity and 
Pain Interference calculated 
based on responses to 
questions.
Cleeland, C. S., & Ryan, K. M. (1994). Pain 
assessment: Global use of the Brief Pain 
Inventory. Annals Academy of Medicine, 
Singapore, 23(2):129-138.
Keller, S., Bann, C. M., Dodd, S. L., Schein, 
J., Mendoza, T. R., & Cleeland, C. S. 
(2004). Validity of the brief pain inventory 
for use in documenting the outcomes of 
patients with noncancer pain. The Clinical 
Journal of Pain, 20(5), 309-318.
Medical 
Outcomes 
Study HIV 
Health Survey 
(MOS-HIV)
Questionnaire, subscale 
scores for  Physical Quality of 
Life and Mental Quality of Life 
are calculated based on 
responses to questions.
Wu AW, Revicki DA, Jacobson D, Malitz 
FE. (1997). Evidence for reliability, validity 
and usefulness of the Medical Outcomes 
Study HIV Health Survey (MOS-HIV). Qual 
Life Res, 6(6):481-493.
Hospital Anxiety 
and Depression 
Scale (HADS) 
Questionnaire, subscale 
scores for depression or 
anxiety calculated based on 
responses to questions.
Bjelland, I., Dahl, A. A., Haug, T. T., & 
Neckelmann, D. (2002). The validity of the 
Hospital Anxiety and Depression Scale: an 
updated literature review. Journal of 
Psychosomatic Research, 52(2), 69-77.
Stern, A. F. (2014). The hospital anxiety 
and depression scale. Occupational 
Medicine, 64(5), 393-394.
Pain 
Catastrophizing 
Scale
Questionnaire, overall score 
calculated based on 
responses to questions.
Osman, A., Barrios, F. X., Gutierrez, P. M., 
Kopper, B. A., Merrifield, T., & Grittmann, L. 
(2000). The Pain Catastrophizing Scale: 
Further psychometric evaluation with adult 
samples. Journal of Behavioral Medicine, 
23(4), 351-365. 
Osman, A., Barrios, F. X., Kopper, B. A., 
Hauptmann, W., Jones, J., & O'neill, E. 
(1997). Factor structure, reliability, and 
validity of the Pain Catastrophizing Scale. 
Journal of Behavioral Medicine, 20(6), 589-
605.
Brief Resilience 
Scale 
Questionnaire, overall score 
calculated based on 
responses to questions
Kyriazos, T. A., Stalikas, A., Prassa, K., 
Galanakis, M., Yotsidi, V., & Lakioti, A. 
(2018). Psychometric evidence of the Brief 
Resilience Scale (BRS) and modeling 
distinctiveness of resilience from 
depression and stress. Psychology, 9(7), 
1828-1857.
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
Pain 
management  
questionnaire  
Questionnaire
No reliability or validity to report; questions 
are custom designed for this study.
Tracking of 
adherence to 
treatment 
Daily question via text 
message
No reliability or validity to report; question is  
custom designed for this study.
Post-
intervention 
Satisfaction 
Questionnaire   
Questionnaire
No reliability or validity to report; questions 
are custom designed for this study.
Follow up 
questionnaire  
Questionnaire 
No reliability or validity to report; questions 
are custom designed for this study.

Ethnographic Studies, Interviews, Or Observation: Not applicable.  

Subject Identifiers: No subject identifiers outside of the participant identification number will 
be linked to the data. 
B.
Secondary Data Collection: Not applicable.  
1.10 Timetable/Schedule of Events
Enrollment will be done in a rolling fashion over several months. The chart below outlines the overall 
timetable. 
Timetable 
Recruitment of Participants
Cross-sectional phase and interventional phase
May 2022 – June 2024
Screening for Eligibility
Cross-sectional phase and interventional phase
May 2022 – June 2024
Consenting 
Cross-sectional phase and interventional phase 
May 2022 – June 2024
Baseline Testing (Week 0)
Cross-sectional phase and interventional phase
May 2022 – June 2024
Group assignment and instruction in 
interventions
Interventional phase only
May 2022 – June 2024
Home-based Interventions   
(6 week period)
Interventional phase only
May 2022 – July 2024
Post-intervention Testing 
(Week 7) 
Interventional phase only
May 2022 – July  2024 
Follow up questionnaire. 
April  2024 – Sept.  2024 
Data Analysis
Ongoing over the course of the study through 
Sept.  2024
Manuscript Preparation and Submission
Sept. 2024 – Jan. 2025 
2.0 Project Management
2.1 Research Staff and Qualifications
Study Personnel
(Role)
Credentials
Qualifications
David Kietrys 
(PI)
PT, PhD, FCPP 
PhD from Temple University. 
Faculty at Rutgers School of Health Professions.
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
Prior PI and author of several studies on the topic of 
HIV-related disability and neuropathy. Has served as 
PI on several prior studies as noted on record with 
the Rutgers eIRB.   
Office located across the hall from the Blackwood 
study site. 
Judith Barberio
(Co-investigator) 
PhD, RN, APN-c
Faculty at Rutgers School of Nursing.
Extensive clinical and research experience in HIV.
Office located in same building as Newark  study site.
James Scott Parrott
(Co-investigator; 
Statistician)
PhD
Faculty at Rutgers School of Health Professions.
Statistician and co-director of Rutgers School of 
Health Professions Methodology and Statistics 
Support Team.  Co-investigator along with PI on prior 
HIV-related studies. 
Richard Ferraro
(Co-investigator)
PT, PhD
Faculty at Rutgers School of Health Professions.
Expertise in use of Zeno instrumented walkway and 
gait analysis. 
Adrienne Simonds
(Co-investigator)
PT, PhD 
Faculty at Rutgers School of Health Professions.
Research experience in chronic pain and TENS for 
management of chronic pain. 
 
 
Oonagh Breen 
(Study staff)
DPT student 
Student of PI; will be trained by PI in any relevant 
study procedures. 
Shobha 
Swaminathan
MD, MB, BS
Associate Professor of Medicine at Rutgers New 
Jersey Medical School. She is the Clinical Research 
Site Leader for the NIH-funded clinical trials unit at 
NJMS. Infectious disease physician with special 
interest in HIV.
2.2 Research Staff Training
All persons assisting with this project have reviewed and the protocol and if appropriate based on 
their role, trained in study procedures by PI David Kietrys (consenting and all procedures except 
ZENO instrumented walkway and Mid-Thigh Pull) or Richard Ferraro (ZENO instrumented walkway 
and Mid-Thigh Pull).  All have been debriefed in their respective roles in the study. Ongoing email 
communications between team members will assure fidelity to study procedures.     
2.3 Resources Available
This study is funded by a $5000 grant from Rutgers Interdisciplinary Center for HIV Research 
(RICHR). Any over-run costs will be absorbed by the PI’s discretionary account and/or by his 
Department.  Other resources available are existing equipment in the PI’s department (ZENO 
instrumented walkway, PKMAS gait analysis software, Mid-thigh pull testing equipment, digital 
algometer); the PI will have access to the equipment throughout the study.  Space for consenting and 
data collection will be provided by the PI (Kietrys)  in his program/department labs  located in 
Blackwood NJ and Newark NJ or by the William Way Community Center. Co-investigator James 
Parrott is a statistician and will be supporting data analysis. 
The testing and the interventions used in this study pose negligible risk to participants. However, should 
any need for medical or psychological support emerge, the PI (Kietrys)   will make appropriate referrals 
for participants who sustain and injury or illness as a direct consequence of participation in the study. 
 
2.4 Research Sites
Rutgers SHP site:  200 College Drive, Jefferson Hall #317, Blackwood, NJ.  
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
Rutgers SHP site, 65 Bergen St.  Newark, NJ.  St. Michael’s Medical Center, 111 Central Ave., Newark, 
NJ 07102
Jefferson Health New Jersey (Kennedy Health Systems), 333 Laurel Oak Road, Voorhees, NJ 08043; 
354 Hurffville-Crosskeys Road, Sewell, NJ 08080 and 80 Tanner Street, Haddonfield, NJ 08033
William Way Community Center, 1315 Spruce St., Philadelphia, PA (data collection site) 
Jefferson Health, 400 Laurel Oak Road, Voorhees, NJ 08043 (data collection site)
Broadway House, 298 Broadway, Newark NJ 07104 (data collection site)
Rutgers UHosp site (office of Dr. Swaminathan), 140 Bergen St Level D, Newark, NJ 07103 (recruitment 
site) 
3.0 Multi-Center Research
 
Not applicable. 
 
4.0 Subject Considerations
4.1 Subject Selection and Enrollment Considerations 
A.
Method to Identify Potential Subjects
Methods to identify potential participants will be flyers at 3 HIV treatment centers known to the PI 
(Kietrys) and co-investigators (Barberio, Swaminathan): Jefferson Health New Jersey (in 
Voorhees NJ, Sewell NJ, and Haddonfield NJ)  Peter Ho Memorial Clinic at St. Michaels Medical 
Center, 111 Central Ave, Newark NJ,  and office of Dr. Swaminathan, 140 Bergen St Level D, 
Newark, NJ respectively. Kietrys, Barberio and Swaminathan have long standing relationships 
with these centers and provide care to patients at these centers. No research activities will take 
place at these sites. Only recruitment will take place at these sites. Medical staff at these facilities 
will be made aware of the study should they choose to share information about the study with 
their patients via flyers that are available at these facilities. The flyer for the study will be shared 
with HIV support groups and HIV organizations in NJ that are identified over the course of the 
study. 
In addition, the information about the study will be sent to HIV+ adults within a 25-mile radius of 
Newark NJ via ResearchMatch.org (RM).   A preliminary search on RM determined there are 70 
HIV+ adults within a 25-mile radius of Newark NJ who are registered with RM. 
Potential participants who express interest will be interviewed by phone or HIPAA compliant 
ZOOM meeting to determine eligibility. 
B.
Recruitment Details
Recruitment by Kietrys, Barberio, and Swaminathan at Jefferson Health New Jersey in Voorhees 
NJ,  Peter Ho Memorial Clinic at St. Michaels Medical Center in Newark NJ, and office of Dr. 
Swaminathan, 140 Bergen St Level D, Newark, NJ will begin upon IRB approval and continue 
through March of 2024. Materials will consist of flyer that is made available to patients at these 
as well as other HIV treatment centers in NJ, Buddies of New Jersey, Hyacinth AIDS Foundation, 
and other HIV support groups and organizations in NJ that are identified over the course of the 
study.  
Information about the study will be sent to HIV+ adults within a 25-mile radius of Newark NJ via 
ResearchMatch.org (RM); as per the RM process, individuals who express interest will then 
receive an email from PI David Kietrys with additional study information and an invitation to 
arrange a phone call to go over screening questions and determine eligibility.
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
C.
Subject Screening
Individuals will be screened for eligibility during a phone call or by HIPAA compliant ZOOM 
meetings by David Kietrys (PI) or  Oonagh Breen (study staff). Screening will involve a series 
scripted questions pertaining to inclusion and exclusion criteria. Individuals will be advised upon 
conclusion of the call or ZOOM if they are eligible to participate in the study. 

Inclusion Criteria
The inclusion criteria for all participants will be:

diagnosis of HIV infection currently treated with ART

CD4 count of at least 200 cells/mm3

18-89 years old

able to read and write in English

means to travel to a study site.
Half of the sample (those continuing on to the interventional phase) will have painful DSP in the 
feet. To screen for DSP, potential participants will be asked if they have been diagnosed with DSP 
in their feet and the Single Question Neuropathy Screen57,58 (specifically for symptoms in the feet) 
will be administered. An affirmative response to either question will be used to classify them as 
having DSP.  For those with DSP, an additional inclusion criteria are:  

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

availability of a mobile phone to receive text messages over the course of the 
intervention period     

for interventional phase only: no use of TENS or mindfulness meditation in the prior 6 
months

Exclusion Criteria
Exclusion criteria include certain conditions as listed in the chart below. 
Exclusion Criterion
Justification for Exclusion
current opportunistic infection(s)
presence 
suggests 
that 
the 
patient 
is 
severely 
immunocompromised and in need of medical attention  
CD4 count <200 cells/mm3
presence 
suggests 
that 
the 
patient 
is 
severely 
immunocompromised and in need of medical attention
dementia
patient would be unable to successfully complete 
questionnaires
uncontrolled psychiatric disorder
patient’s behaviors and responses to questionnaires may 
be altered or invalid
wounds or sores on the feet
may not be safe for patient to participate with testing. 
wounds or sores may affect gait 
musculoskeletal or neurological 
conditions (other than DSP) that may 
affect gait  
Aim 1 seeks to determine how DSP affects gait, so persons 
with other conditions that affect gait (such as hemiplegia, 
amputation, multiple sclerosis, etc.) are an exclusion
pregnancy
may affect gait and other physical performance tests 
For participants who have difficulty reading and comprehending the questionnaires, we will 
accommodate them by having a study team member read aloud each of the questions prior to 
asking them to enter a response. 
 
4.2 Secondary Subjects
Not applicable. 
4.3 Number of Subjects
A. Total Number of Subjects
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PI: David Kietrys
Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
Number of subjects who are expected to be screened: 160
Number of subjects who are expected to be enrolled: 80
Number of subjects needed to complete the research procedures: 72
B. Total Number of Subjects If Multicenter Study
Not applicable.
C. Feasibility
Given the PI’s prior experience with recruitment of HIV+ participants for prior studies, coupled with 
access to 3 key HIV treatment centers, it is highly feasible that the target number of participants can 
be recruited by March 2024. It is estimated that there are more than 37,000 PLHIV in New Jersey, 
and DSP is common co-morbidity in PLHIV (with prevalence exceeding 40%).  
4.4 Consent Procedures
A. Consent Process

Location of Consent Process
Consent will take place at either of the 4 study sites (200 College Drive, Jefferson Hall #317, 
Blackwood, NJ or 65 Bergen St., Newark, NJ or Willam Way Center in Philadelpihia, PA or 
Broadway House in Newark NJ)  

Ongoing Consent
Not applicable. This is a relatively short-term study (total time involvement for those in the 
interventional phase is approximately 8 weeks).

Individual Roles for Researchers Involved in Consent
David Kietrys and  Oonagh Breen   will be involved with consent process. Dr. Kietrys will offer 
to email the consent form to the potential participants prior to the date they are scheduled for 
baseline data collection if they wish to receive it by email and read in advance of the 
consenting date.  Upon arrival on the date for consenting and baseline testing, Kietrys or 
Breen  will review the consent form and answer any questions. Signed consent forms will be 
scanned into a separate secure password protected folder on the university servers and 
accessible only to appropriate project team members, after which paper copies will be 
shredded.

Consent Discussion Duration
It is estimated that between 10 and 15 minutes will be devoted to consent discussion. More 
time (up to 30 minutes) can be allotted if needed.  

Coercion or Undue Influence
As part of the consent form and consent discussion, potential participants will be clearly 
advised (both in writing on the consent form and verbally during the discussion) that their 
participation is entirely voluntary and that they may withdraw from the study at any time. 

Subject Understanding
The details of the study will be described to potential participants who are deemed eligible 
(based on the screening). Furthermore, the details of the study will be reviewed with the 
potential participants during the consenting discussion. Testing procedures will be 
summarized prior to the testing session. During tests, explicit and clear instructions regarding 
test procedures will be given. Those randomized to the TENS group will receive an 
instruction manual and a one-on-one ZOOM session to educate them on how to use TENS. 
For randomized to the mindfulness meditation group will watch a brief orientation video  , and 
then receive text messages with links to the audio files the will guide the meditation.  Those 
randomized to the standard care group will continue to see any health care providers that 
they normally see and continue to use any pain management strategies that they normally 
use.  In addition, they will be offered TENS and mindfulness meditation audios upon 
conclusion of study. At all points along the way, participants will be given the opportunity to 
ask any questions that they may have. 
B.
Waiver or Alteration of Consent Process 
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Protocol Version Date:     v10.0 3.1.2024      

Waiver or Alteration Details
Not applicable.  

Destruction of Identifiers
Not applicable, as a waiver of consent is not being requested.  

Use of Deception/Concealment
Not applicable.   
a.
Minimal Risk Justification
The testing procedures are all non-invasive and will be closely guided and monitored by 
study personnel. The demands of the physical testing procedures do not exceed the 
demand of typical daily activity for most participants. The treatments used in this study are 
non-invasive, non-experimental, home-based, and are widely used in health care. Adverse 
side effects of the treatments used in this study are not expected.  
b.
Alternatives
Not applicable, as a waiver of consent is not being requested. 
c.
Subject Debriefing
Not applicable, as a waiver of consent is not being requested.
C.
Documentation of Consent

Documenting Consent
Participants will be asked to sign a hard copy of a consent form. Thus, their consent will be 
documented in writing. Signed consent forms will be scanned into a separate secure 
password protected folder on the university servers and accessible only to appropriate project 
team members, after which paper copies will be shredded.  

Waiver of Documentation Of Consent (i.e., will not obtain subject’s signature)
Not applicable.  
4.5 Special Consent/Populations
A.
Minors-Subjects Who Are Not Yet Adults 

Parental Permission
Not applicable as minors will not be enrolled in this study. 

Non-Parental Permission
Not applicable as minors will not be enrolled in this study.

Assent Process
Not applicable as minors will not be enrolled in this study.   

Documentation of Assent
Not applicable as minors will not be enrolled in this study.  

Reaching Age of Majority During Study
Not applicable as minors will not be enrolled in this study.  
B.
Wards of the State 

Research Outside of NJ Involving Minors
Not applicable as minors will not be enrolled in this study.
C.
Non-English-Speaking Subjects
Not applicable. Only participants who speak, read and write in English will be enrolled.  

Process for Non-English-Speaking Subjects
Not applicable. 

Short Form Consent for Non-English Speakers
Not applicable. 
D.
Adults Unable to Consent / Decisionally Impaired Adults
Not applicable. 

NJ Law-Assessment of Regaining the Capacity to Consent
Not applicable. 

Capacity to Consent
Not applicable. 
a.
NJ Law-Selecting A Witness 
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Not applicable. 
b.
Removing a Subject
If the subject expresses dissent to continued participation, they will be withdrawn from the 
study. 
 
4.6 Economic Burden and/or Compensation for Subjects
A. Expenses 
The expenses incurred by participants are any expenses related to travel that exceed the $5 
cash travel stipend provided on on-site testing days. Participants in the interventional phase   
may incur costs for mobile device data usage depending on their plan.
B.
Compensation/Incentives
All participants will receive a $25 gift card and $5 cash at the time of baseline testing (W0). The 
participants with DSP who are continuing on to the interventional phase will receive a second 
$25 gift card and $5 cash at the time of post-intervention testing (W7). The sum is felt to provide 
a reasonable incentive. The $5 cash payment is intended to offset travel costs such as gas or 
bus fare. 
C.  Compensation Documentation
The PI (Kietrys) will maintain a spreadsheet ledger to document that participants received the gift 
cards and the cash payment. The spreadsheet will include columns for participant (study) ID#, the 
item ($25 gift card; $5 cash), the serial # of the gift card, and the date dispensed. 
4.7 Risks of Harm/Potential for Benefits to Subjects
A.
Description of Risks of Harm to Subjects

Reasonably Foreseeable Risks of Harm
Foreseeable risk of harm, 
discomfort, hazard or 
inconvenience
Probability, Magnitude, Duration, Reversal
Fatigue after testing session
Probability: moderate
Magnitude: mild to moderate
Duration: remainder of test day
Reversal: likely resolved by next day
Delayed onset muscle 
soreness in lower extremities  
day after testing session
Probability: low
Magnitude: mild  
Duration: 1-2 days after testing session
Reversal: likely resolved by day 3 after testing session
Emotional discomfort due to 
question(s) on 
questionnaires 
Probability: negligible/low
Magnitude: mild to moderate
Duration: remainder of test day
Reversal: likely resolved by next day
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Emotional discomfort during 
or after meditation
Probability: negligible/low
Magnitude: mild to moderate
Duration: day of meditation 
Reversal: likely resolved by next day
Skin irritation under 
electrode application site 
after TENS use
Probability: negligible
Magnitude: mild  
Duration: 1-2 days after use
Reversal: likely resolved by day 3 after use
Inconvenience associated 
with finding a drop off 
location for pre-paid shipping 
for return of Actigraph device
Probability: low
Magnitude: low
Duration: same day as drop off day
 
For those in interventional 
phase, inconvenience 
associated with need for 
participant do use their own 
mobile phone or device to 
respond to respond to daily 
text message re: adherence 
to treatment 
Probability: low
Magnitude: mild  
Duration: throughout the 6-week intervention period for those 
participating in the interventional phase
 

Risk of Harm from an Intervention on a Subject with an Existing Condition
All risks disclosed in the preceding chart are provided with assumption that the participant is 
HIV+ and may have painful neuropathy in the feet.  Risk of fatigue or delayed onset muscle 
soreness may be greater in individuals who are deconditioned or obese. Risk of emotional 
discomfort may be greater in individuals with anxiety, depression or past trauma.

Other Foreseeable Risks of Harm
Other foreseeable risk includes risks a possible loss of confidentiality. 

Observation and Sensitive Information
Not applicable.
B.
Procedures which Risk Harm to Embryo, Fetus, and/or Pregnant Subjects
Not applicable.
C.
Risks of Harm to Non-Subjects
Not applicable. 
D.
Assessment of Social Behavior Considerations
Participants whose observed social behavior is indicative of severe psychological distress or 
violence, participants whose HAD scores are indicative of severe depression or anxiety, and 
participants whose Pain Catastrophizing Scale score is indicative of clinically relevant 
catastrophizing will be advised to seek medical attention or counseling. The PI will provide with 
such participants with a list of mental health recourses and mental health treatment centers in the 
area where the participant resides.
E.
Minimizing Risks of Harm
Procedures to assure confidentiality of data: 
All data will ultimately be stored in a password protected folder on the university servers and 
accessible only to appropriate project team members. Data will be linked only to participant study 
ID#s, i.e. key codes. The de-identified data file will be shared with Dr. James Parrott (co-
investigator and statistician) and other co-investigators as needed for purposes of analysis. A 
separate secure spreadsheet that links participant ID#s to their names will be kept on a separate 
password protected folder on a university server available only to Kietrys (PI) and Barberio (co-
investigator) and will be accessed only if the code needs to be broken in order to contact a 
participant based on any measurements or questionnaire responses that suggest need for a 
referral for medical attention or counseling. Signed consent forms will be scanned into a separate 
secure password protected folder on the university servers and accessible only to appropriate 
project team members, after which paper copies will be shredded.  Kietrys (PI) is responsible for 
assuring security of all de-identified data, the spreadsheet that links participant names to 
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participant ID#s, and signed consent forms. Any co-investigators and study staff involved with 
data collection (Ferraro, Lynch,  Breen) will be trained by PI (Kietrys) in all security protocols. 
Data will be entered into the RedCap platform and RedCap via survey links that are created for 
this study, and will later transferred to in a password protected folder on the university servers 
and accessible only to appropriate project team members. 
ZENO walkway data will be stored and processed on a password protected laptop dedicated to 
the ZENO walkway. The laptop with ZENO walkway data will be continuously within the line of 
sight of Kietrys or Ferraro during data collection and securely stored during transport between 
data collection locations. ZENO walkway data will be transferred from the dedicated laptop to a 
secure password protected folder on the university servers. After processing ZENO walkway data 
with PKMAS gait analysis software, the raw and aggregate ZENO walkway data will be 
uploaded into the RedCap project.   
Mid-thigh pull test data will be uploaded into the RedCap project. 
Actigraph data will be transferred from the Actigraph device to a password protected folder on the 
university servers, after which Actigraph devices will be wiped of participant data and disinfected 
prior to the device being used by a subsequent participant.  After processing Actigraph data with 
ActiLife software, the raw and aggregate Actigraph data will be uploaded into the RedCap project.
Text messages and responses to text messages about adherence to interventions (TENS and 
MM groups only during the 6 weeks of home-based treatment) will be done through a study-
specific password protected Twilio account, and then uploaded into the RedCap project.
Procedures to monitor subjects for safety and minimize risk of harm during testing: 
Study staff will follow CDC and Rutgers COVID precautions (such as wearing a face mask and a 
face shield) throughout the testing session.  Study staff will wash their hands before and after a 
testing session and sanitize their hands frequently throughout a testing session. All equipment 
including pens or iPads used for questionnaires will be disinfected both prior to and immediately 
following a testing session for a given participant. Participants will be scheduled one at a time 
with no overlap. If more than one participant is scheduled on the same day, there will be a full 
hour gap between participants to allow time for disinfection of all testing equipment. Participants’ 
appointments will be postponed if they are experiencing symptoms of COVID-19 or are febrile or 
had a high risk exposure to a COVID infected individual during the week prior to their testing 
appointment. This will be determined by the PI or study staff calling the participant the day prior to 
or the morning of their appointment.  Prior to testing procedures, participants’ resting heart rate, 
blood pressure, respiratory rate and temperature will be taken. If vital signs values or temperature 
are outside of acceptable ranges, testing will not proceed on that date. All participants will be 
required to follow COVID precautions that are in place at the time testing throughout the testing 
session. Currently, this includes participants wearing masks throughout the session, sanitizing 
their hands with hand sanitizer prior to the start of testing and prior to leaving the testing session, 
and maintaining social distance of at least 6’ between study team personnel and participants will 
be maintained except for when testing procedures require closer proximity. All participants will be 
guided by and supervised by a study team member throughout all testing procedures. During the 
balance tests that are included the Short Physical Performance Battery, the PI or his designated 
study team member will stand adjacent to the participant and provide guarding in case the 
participants experiences a loss of balance. The other test that will require proximity of less than 6’ 
is pain pressure threshold testing. After each test, participants will be asked if they would like to 
sit and rest before continuing on to the next test. If participants appear to be in any distress or 
become lightheaded during testing, they will be given the option of lying down on a treatment 
table or sitting in a chair, and their vital signs will be reassessed. 
Procedures to monitor subjects for safety and minimize risk of harm during the period of 
home-based interventions: Participants in the interventional phase will be notified on baseline 
testing day that they should contact the PI if any problems arise during the 6 week at-home 
intervention period. Participants in the TENS will be educated on how to inspect their skin after 
removing electrodes following a TENS treatment. Because DSP typically causes impaired 
sensation in the distal extremities TENS electrodes will not be placed on the feet. Rather, the 
locations will be more proximal at designated points on the lower extremities that have been 
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assessed (on the day of baseline testing) by study personnel to have protective sensation as 
assessed with a 5.07 gauge (10 gram) Semmes-Weinstein monofilament. Participants in the 
TENS group who do not have protective sensation over the TENS sites in the legs will not be 
provided with TENS treatment.   .  In addition, all participants in the interventional phase will be 
contacted once a week by text message meeting and will be asked if they are experiencing any 
problems of difficulties.    

Certificate of Confidentiality
Not applicable.  

Provisions to Protect the Privacy Interests of Subjects
The instructions given to participants for all of the questionnaires will include mention that the 
participant and skip (not respond) to any questions that they don’t wish to respond to. 
F.
Potential Benefits to Subjects
Participants in the interventional phase of the study may benefit as the use of TENS or 
mindfulness meditation and may experience improvements in a number of outcomes such as 
pain, quality of life, physical performance and physical activity. Furthermore, participants may 
become less reliant on pain medication, alcohol or substances for pain relief. The probability of 
such benefits is expected to be high in those in the TENS and meditation groups, with magnitude 
ranging from small improvements to large improvements that will vary by individual. The duration 
of such benefits may be prolonged if the participants continue with the use of TENS or meditation 
after the study concludes.    
5.0 Special Considerations
5.1 Health Insurance Portability and Accountability Act (HIPAA)
We are not requesting a waiver of HIPPA authorization. All data from obtained in the study will be de-
identified and linked only to the participant’s study ID number, i.e. not health information or data will 
be linked to their name or other identifying information. 
5.2 Family Educational Rights and Privacy Act (FERPA)
Not applicable.  
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
A.
Special Populations

Not applicable. 
5.4 General Data Protection Regulation (GDPR)
Not applicable.  
5.5 NJ Access to Medical Research Act (Surrogate Consent)
Not applicable. 
6.0 Data Management Plan
6.1 Data Analysis
Cross-sectional phase:  We will test for baseline differences between those with painful DSP and those 
without painful DSP for the set of variables using independent t-tests (or Mann-Whitney tests if 
distributions are non-normal). Differences between those with and without DSP on potential 
demographic or clinical confounders will be adjusted for statistically.
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Interventional phase:  Assuming normality of the outcome variables of interest, between group repeated 
measures analysis of variance will be used to evaluate differences within and between groups for each 
outcome separately. In the case of non-normal outcome variable distribution, we will consider 
transforming the measure to normalize. If normalization is not warranted, then within group changes 
will be tested using a Friedman’s test and between group differences will be compared descriptively. 
Data will be analyzed using both per-protocol and intention-to-treat analyses in the case of dropouts.
6.2 Data Security
 
All data will ultimately be stored in a password protected folder on the university servers and 
accessible only to appropriate project team members. Data will be linked only to participant study 
ID#s, i.e. key codes. The de-identified data file will be shared with Dr. James Parrott (co-
investigator and statistician) and other co-investigators as needed for purposes of analysis. A 
separate secure spreadsheet that links participant ID#s to their names will be kept on a separate 
password protected folder on a university server available only to Kietrys (PI) and Barberio (co-
investigator) and will be accessed only if the code needs to be broken in order to contact a 
participant based on any measurements or questionnaire responses that suggest need for a 
referral for medical attention or counseling. Signed consent forms will be scanned into a separate 
secure password protected folder on the university servers and accessible only to appropriate 
project team members, after which paper copies will be shredded.  Kietrys (PI) is responsible for 
assuring security of all de-identified data, the spreadsheet that links participant names to 
participant ID#s, and signed consent forms. Any co-investigators and study staff involved with 
data collection (Ferraro, Lynch, Breen) will be trained by PI (Kietrys) in all security protocols. 
Data will be entered into the RedCap platform and RedCap via survey links that are created for 
this study, and will later transferred to in a password protected folder on the university servers 
and accessible only to appropriate project team members. 
ZENO walkway data will be stored and processed on a password protected laptop dedicated to 
the ZENO walkway. The laptop with ZENO walkway data will be continuously within the line of 
sight of Kietrys or Ferraro or Lynch  during data collection and securely stored during transport 
between data collection locations. ZENO walkway data will be transferred from the dedicated 
laptop to a secure password protected folder on the university servers. After processing ZENO 
walkway data with PKMAS gait analysis software, the raw and aggregate ZENO walkway data 
will be uploaded into the RedCap project.   
Mid-thigh pull test data will be uploaded into the RedCap project. 
Actigraph data will be transferred from the Actigraph device to a password protected folder on the 
university servers, after which Actigraph devices will be wiped of participant data and disinfected 
prior to the device being used by a subsequent participant.  After processing Actigraph data with 
ActiLife software, the raw and aggregate Actigraph data will be uploaded into the RedCap project.
Text messages and responses to text messages about adherence to interventions (TENS and 
MM groups only during the 6 weeks of home-based treatment) will be done through a study-
specific password protected Twilio account, and then uploaded into the RedCap project.
6.3 Data and Safety Monitoring
A.
Data/Safety Monitoring Plan
This study does not pose greater then minimal risk of harm. However, during on-site testing, 
participants will be closely monitored and supervised to assure safety. 
The PI will maintain a record of any concerns or problems reported by participants. If such concerns 
or problems are serious and/or an adverse event, they will be reported to the IRB.
The PI will review data on an ongoing basis after any baseline (W0) or post-intervention (W7) testing 
sessions. Participants in the interventional phase will be reminded weekly via text message (using a 
study specific password protected Twilio account) to contact the PI if they are experiencing any 
problems or difficulties or have questions. Post-intervention (W7) data will be reviewed by the PI 
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(Kietrys) within 24 hours after the collection of data to assess if any data suggests that the participant 
was harmed.  
 
B.
Data/Safety Monitoring Board Details
Not applicable as this study does not pose greater then minimal risk of harm.   
6.4 Reporting Results
A.
Individual Subjects’ Results 
Individual results will not be shared with participants. However, if participants have any test scores 
(such as abnormal vital signs or observed behavior that is suggestive of severe depression or 
suicidal ideation), they will be alerted of the finding by the PI (Kietrys)   and advised to seek medical 
attention or counseling. 
 
B.
Aggregate Results
Study findings will be posted to ClinicalTrials.gov.  Participants who wish to review aggregate 
results of the study will be directly to ClinicalTrials.gov. 
C.
Professional Reporting
Results of the study will be submitted for presentation in the form of a poster or platform at least 
one national or international conference such as the American Physical Therapy Association 
Combined Sections Meeting.  It is anticipated that the study will yield at least 2 manuscripts that 
will be submitted to appropriate peer-reviewed journals such as Physical Therapy or AIDS Care.  
D.
Clinical Trials Registration, Results Reporting and Consent Posting
This study includes both an observational phase (cross-sectional phase) and a pilot clinical trial 
(interventional phase). It will be registered with ClinicalTrials.gov.
6.5 Secondary Use of the Data   
Not applicable. Data will not be shared with other researchers.  
7.0 Research Repositories – Specimens and/or Data
Not applicable. 
8.0 Approvals/Authorizations
Not applicable.  Required Departmental Reviews for study personnel from Rutgers have been noted in  
Section 1.3 of the eIRB application. 
9.0 Bibliography
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Erlandson KM, Schrack JA, Jankowski CM, Brown TT, Campbell TB. Functional 
impairment, disability, and frailty in adults aging with HIV-infection. Curr HIV/AIDS Rep. 
2014;11(3):279-290.
2.
Rodriguez-Penney AT, Iudicello JE, Riggs PK, et al. Co-morbidities in persons infected 
with HIV: Increased burden with older age and negative effects on health-related quality 
of life. AIDS Patient Care and STDs. 2013;27(1):5-16.
3.
Rusch M, Nixon S, Schilder A, Braitstein P, Chan K, Hogg RS. Impairments, activity 
limitations and participation restrictions: Prevalence and associations among persons 
living with HIV/AIDS in British Columbia. Health and Quality of Life Outcomes. 
2004;2(1):46.
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Protocol Version Date:     v10.0 3.1.2024      
4.
Harding R, Lampe FC, Norwood S, et al. Symptoms are highly prevalent among HIV 
outpatients and associated with poor adherence and unprotected sexual intercourse. 
Sexually Transmitted Infections. 2010;86(7):520-524.
5.
Lee KA, Gay C, Portillo CJ, et al. Symptom experience in HIV-infected adults: A function 
of demographic and clinical characteristics. Journal of Pain and Symptom Management. 
2009;38(6):882-893.
6.
Merlin JS, Cen L, Praestgaard A, et al. Pain and physical and psychological symptoms 
in ambulatory HIV patients in the current treatment era. Journal of Pain and Symptom 
Management. 2012;43(3):638-645.
7.
Miaskowski C, Penko JM, Guzman D, Mattson JE, Bangsberg DR, Kushel MB. 
Occurrence and characteristics of chronic pain in a community-based cohort of indigent 
adults living with HIV infection. The Journal of Pain. 2011;12(9):1004-1016.
8.
Silverberg MJ, Jacobson LP, French AL, Witt MD, Gange SJ. Age and racial/ethnic 
differences in the prevalence of reported symptoms in human immunodeficiency virus-
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2009;38(2):197-207.
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Parker R, Stein DJ, Jelsma J. Pain in people living with HIV/AIDS: A systematic review. 
Journal of the International AIDS Society. 2014;17(1):18719.
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Johannes CB, Le TK, Zhou X, Johnston JA, Dworkin RH. The prevalence of chronic pain 
in United States adults: Results of an Internet-based survey. The Journal of Pain. 
2010;11(11):1230-1239.
11.
Frich LM, Borgbjerg FM. Pain and pain treatment in AIDS patients: A longitudinal study. 
J Pain Symptom Manage. 2000;19(5):339-347.
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Merlin JS. Chronic pain in patients with HIV infection: What clinicians need to know. Top 
Antivir Med. 2015;23(3):120-124.
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Merlin JS, Westfall AO, Chamot E, et al. Pain is independently associated with impaired 
physical function in HIV-infected patients. Pain Medicine. 2013;14(12):1985-1993.
14.
Kietrys D, Myezwa H, Galantino ML, et al. Functional limitations and disability in persons 
living with HIV in South Africa and United States: Similarities and differences. Journal of 
the International Association of Providers of AIDS Care (JIAPAC). 2019;18.1-9.
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Sabin CA, Harding R, Bagkeris E, et al. Pain in people living with HIV and its association 
with healthcare resource use, well being and functional status. AIDS. 2018;32(18):2697-
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Van de Ven NS, Ngalamika O, Martin K, Davies KA, Vera JH. Impact of musculoskeletal 
symptoms on physical functioning and quality of life among treated people with HIV in 
high and low resource settings: A case study of the UK and Zambia. PLoS ONE. 
2019;14(5):e0216787.
17.
Kooij KW, Wit FW, Schouten J, et al. HIV infection is independently associated with 
frailty in middle-aged HIV type 1-infected individuals compared with similar but 
uninfected controls. AIDS. 2016;30(2):241-250.
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Petit N, Enel P, Ravaux I, et al. Frail and pre-frail phenotype is associated with pain in 
older HIV-infected patients. Medicine. 2018;97(6).
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daCosta DiBonaventura M, Gupta S, Cho M, Mrus J. The association of HIV/AIDS 
treatment side effects with health status, work productivity, and resource use. AIDS 
Care. 2012;24(6):744-755.
20.
Ellis RJ, Rosario D, Clifford DB, et al. Continued high prevalence and adverse clinical 
impact of human immunodeficiency virus-associated sensory neuropathy in the era of 
combination antiretroviral therapy: The CHARTER Study. Arch Neurol. 2010;67(5):552-
558.
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Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
21.
Nicholas PK, Voss J, Wantland D, et al. Prevalence, self-care behaviors, and self-care 
activities for peripheral neuropathy symptoms of HIV/AIDS. Nursing & Health Sciences. 
2010;12(1):119-126.
22.
Ances BM, Vaida F, Rosario D, et al. Role of metabolic syndrome components in HIV-
associated sensory neuropathy. AIDS. 2009;23(17):2317-2322.
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Ferrari S, Vento S, Monaco S, et al. Human immunodeficiency virus-associated 
peripheral neuropathies. Mayo Clinic Proceedings. 2006;81(2):213-219.
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Lehmann HC, Chen W, Borzan J, Mankowski JL, Höke A. Mitochondrial dysfunction in 
distal axons contributes to human immunodeficiency virus sensory neuropathy. Ann 
Neurol. 2011;69(1):100-110.
25.
Dorsey SG, Morton PG. HIV peripheral neuropathy: Pathophysiology and clinical 
implications. AACN Clinical Issues. 2006;17(1):30-36.
26.
Maritz J, Benatar M, Dave JA, et al. HIV neuropathy in South Africans: frequency, 
characteristics, and risk factors. Muscle Nerve. 2010;41(5):599-606.
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Robinson-Papp J, Simpson DM. Neuromuscular diseases associated with HIV-1 
infection. Muscle Nerve. 2009;40(6):1043-1053.
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Robinson-Papp J, Morgello S, Vaida F, et al. Association of self-reported painful 
symptoms with clinical and neurophysiologic signs in HIV-associated sensory 
neuropathy. Pain. 2010;151(3):732-736.
29.
Phillips TJ, Brown M, Ramirez JD, et al. Sensory, psychological, and metabolic 
dysfunction in HIV-associated peripheral neuropathy: A cross-sectional deep profiling 
study. Pain. 2014;155(9):1846-1860.
30.
Pillay P, Wadley AL, Cherry CL, Karstaedt AS, Kamerman PR. Psychological factors 
associated with painful versus non-painful HIV-associated sensory neuropathy. AIDS 
and Behavior. 2018;22(5):1584-1595.
31.
Galantino ML, Kietrys DM, Parrott JS, Stevens ME, Stevens AM, Condoluci DV. Quality 
of life and self-reported lower extremity function in adults with HIV-related distal sensory 
polyneuropathy. Phys Ther. 2014;94(10):1455-1466.
32.
Kietrys DM, Parrott JS, Galaniton ML, Davis T, Levin T, O’Brien K. Self-reported 
disability in persons with HIV-related neuropathy is mediated by pain interference and 
depression. Phys Ther. (Submitted.)
33.
Sandoval R, Roddey T, Giordano TP, Mitchell K, Kelley C. Pain, sleep disturbances, and 
functional limitations in people living with HIV/AIDS-associated distal sensory peripheral 
neuropathy. J Int Assoc Provid AIDS Care. 2014;13(4):328-334.
34.
Lucey BP, Clifford DB, Creighton J, Edwards RR, McArthur JC, Haythornthwaite J. 
Relationship of depression and catastrophizing to pain, disability, and medication 
adherence in patients with HIV-associated sensory neuropathy. AIDS Care. 
2011;23(8):921-928.
35.
de Souza A, Caumo W, Calvetti PU, et al. Comparison of pain burden and psychological 
factors in Brazilian women living with HIV and chronic neuropathic or nociceptive pain: 
An exploratory study. PLoS ONE. 2018;13(5):e0196718.
36.
Berner K, Morris L, Baumeister J, Louw Q. Objective impairments of gait and balance in 
adults living with HIV-1 infection: A systematic review and meta-analysis of observational 
studies. BMC Musculoskeletal Disorders. 2017;18(1):325.
37.
Gonzalez-Duarte A, Robinson-Papp J, Simpson DM. Diagnosis and management of 
HIV-associated neuropathy. Neurol Clin. 2008;26(3):821-832.
38.
Merlin JS, Bulls HW, Vucovich LA, Edelman EJ, Starrels JL. Pharmacologic and non-
pharmacologic treatments for chronic pain in individuals with HIV: A systematic review. 
AIDS Care. 2016;28(12):1506-1515.
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39.
Becker WC, Edelman EJ. Potential benefits and harms of prescription opioids in HIV. In: 
Merlin JS, Selwyn PA, Treisman G, Giordano TP, eds. Chronic pain and HIV: A practical 
approach. West Sussex, UK: Wiley Blackwell; 2016.
40.
Sandoval R, Roddey T, Giordano TP, Mitchell K, Kelley C. Randomized trial of lower 
extremity splinting to manage neuropathic pain and sleep disturbances in people living 
with HIV/AIDS. Journal of the International Association of Providers of AIDS Care. 
2016;15(3):240-247.
41.
Mkandla K, Myezwa H, Musenge E. The effects of progressive-resisted exercises on 
muscle strength and health-related quality of life in persons with HIV-related poly-
neuropathy in Zimbabwe. AIDS Care. 2016;28(5):639-643.
42.
Galantino ML, Eke-Okoro ST, Findley TW, Condoluci D. Use of noninvasive 
electroacupuncture for the treatment of HIV-related peripheral neuropathy: A pilot study. 
J Altern Complement Med. 1999;5(2):135-142.
43.
Gale J. Physiotherapy intervention in two people with HIV or AIDS-related peripheral 
neuropathy. Physiotherapy Research International. 2003;8(4):200-209.
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Protocol Short Title: Neuropathy Walks
Protocol Version Date:     v10.0 3.1.2024      
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