Effects of Electrotherapy on Cervical Spine Proprioception, Pain, Anxiety, and Disability in Adults With Subclinical Neck or Upper Quadrant Pain.
Phase: NA
Conditions: Chronic Pain
Sponsor: Loma Linda University

 
 
1
-Title: Effects of Electrotherapy on Pain, Anxiety, Mobility, and Proprioception in Young 
Adults with Mild Neck Pain: A Randomized Controlled Trial 
 
-Authors: Pablo Mleziva PT, PhD(c). Department of Physical Therapy, Assistant Professor, 
Loma Linda University, California, USA. Eric Glenn Johnson PT, DSc. Department of 
Physical Therapy, Professor, Loma Linda University, California, USA. Everett Lohman III PT, 
DSc. Department of Physical Therapy, Professor, Loma Linda University, California, USA.. 
Madeha Jaber Department of Physical Therapy, Professor, Loma Linda University, California, 
USA. Lillian Mleziva Department of Physical Therapy, San Gorgonio Memorial Hospital, 600 
N Highland Springs Ave, Banning, California 92220, USA. Noha Salim Daher Department of 
Public Health, School of Allied Health Professions, Professor, Loma Linda University, 
California, USA 
 
-Institutional Review Board (IRB# 5220149) approved 4/29/2022 at Loma Linda University at 
University. Registered with ClinicalTrials.gov (Identifier: NCT05382039). 
 
-Financial disclosure and Conflict of Interest: I affirm that I have no financial affiliation or 
involvement with any commercial organization that has a direct financial interest in any matter 
included in this clinical trial. 
 
-Corresponding author: Pablo Mleziva Address: 24951 North Circle Drive, Nichol Hall, Loma 
Linda, California, 92354 Email: pmleziva@llu.edu 
 
-Funding: None 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
2
 
 
 
 
1. 
PROTOCOL INFORMATION  
Title: Effects of electrotherapy on cervical spine proprioception, pain, anxiety, and 
disability in adults with subclinical neck or upper quadrant pain. 
Funding Source: School of Allied Health Professions (SAHP)  
Phase of Study: N/A  
Version Date of Protocol: N/A  
 
2. 
PRINCIPAL INVESTIGATOR’S INFORMATION 
PI Name: Eric Glenn Johnson, DSc, PT, MS-HPEd, NCS 
Title: Professor, SAHP, Physical Therapy Department  
Name & Address of Research Institution: Loma Linda University, School of Allied 
Health Professions, Nichol Hall Room #A-712, Loma Linda, CA 92350 
Ext # 47471 FAX # (909) 558-0459 
Email Address: ejohnson@llu.edu 
 
3. 
STUDY PERSONNEL 
Name: Eric Johnson. Email: ejohnson@llu.edu 
Name: Pablo Mleziva. Email: pmleziva@llu.edu 
Name: Everett Lohman. Email: elohman@llu.edu 
Name: Lillian Mleziva. Email: LMleziva@llu.edu 
Name: Noha Daher. Email: ndaher@llu.edu 
Name: Madeha Jaber. Email: mmjaber@students.llu.edu 
 
4. 
STUDY INFORMATION 
Location(s) of Research Activity: SAHP Neuroscience Research Laboratory- Room 
Nichol Hall A-712, 24951 North Circle Drive, Loma Linda, CA 92354. 
Expected Start/Stop Dates of Research: July 1, 2022-June 30, 2023.  
Special Time Sensitivities: N/A 
Type of Research: Experimental 
 
5. 
INCLUSION / EXCLUSION CRITERIA 
Inclusion criteria: Subjects will be adults between 20-40 years of age currently 
enrolled as students at Loma Linda University. There will be three groups. The 

 
 
3
normal group will include twenty subjects with no neck and/or quadrant pain. The 
control group will include twenty subjects with neck and/or upper quadrant chronic 
subclinical pain and the intervention group will include twenty subjects with neck 
and/or upper quadrant chronic subclinical pain.   
Exclusion criteria: Individuals currently receiving clinical pain treatment, pain 
medications within six hours of data collection, acute pain (control and intervention 
groups), individuals with electrotherapy contraindications, and unwilling to receive 
daily SMS text message home program reminder. Exclusion criteria will be 
determined by self-report using a questionnaire.  
 
6. 
SUBJECT RECRUITMENT & SCREENING 
This study will have a sample size of 60 adults (males and females) between 20 to 40 
years of age. This sample size will provide us with enough power to detect the needed 
effect size. The estimated attrition rate is 15 percent. The participants will be 
recruited from the student population at Loma Linda University via flyers, posters, 
hand-outs, mass emails, and word of mouth. The phone script will be used when 
potential subjects contact us after seeing the flyer. 
 
7. 
INFORMED CONSENT PROCESS 
The informed consent will be conducted by Pablo Mleziva in the SAHP Neuroscience 
Research Laboratory with a single potential subject at a time. Participants will have 
the opportunity to ask questions before deciding to participate. Those participants 
who meet inclusion criteria will be identified by a code on all documents other than 
their signature on the informed consent. Twenty participants with no pain will be in 
the normal group. Forty participants with chronic subclinical neck or upper quadrant 
pain will be randomized (random number table will be used) into two groups: twenty 
subjects in the control group, and twenty subjects in the intervention group. All 
participants’ records will be stored in a locked cabinet, in a locked office and stored 
on a secure drive. 
 
8. 
STUDY DESIGN 
a. Background or rationale for this study. 
As defined by the International Association for the Study of Pain (IASP) pain is 
“an unpleasant sensory and emotional experience associated with, or resembling that 
associated with, actual or potential tissue damage.” (IASP, 2021) and one of the most 

 
 
4
common reasons people seek medical care is chronic pain. Approximately 50 million 
adults in United Stated have chronic pain affecting daily lives1 posting public health 
problems in costs of pharmacological management.2,3 The financial cost to care for 
people with chronic pain is more costly than diabetes, cardiovascular and cancer 
combined.4,5 
Chronic pain is persistent or recurrent pain that last longer than 3 months in one 
or more locations in the body even beyond the period of the expected healing 
phase.6,7 Chronic pain can be affected by biological, psychological, and social factors 
that are accompanied by anxiety, depression, frustration, deconditioning, functional 
disability, financial problems and opioid use problems.8,9 As people experience pain, 
that experience and manifestation of pain is unique to each individual and includes 
physical and psychological factors7 making the managing pain and chronic pain can a 
difficult thing to achieve.1  
Facing an opioid epidemic, the Centers of Disease Control and Prevention (CDC) 
reports that studies of 2 weeks to 6 months in duration that utilized effective non-
pharmacological treatments for chronic pain were effective.10 Among the 
recommendations from the CDC for non-opioid and non-pharmacological treatments 
for pain, physical therapy is included.10,11 As physical therapists we find imperative to 
reinforce the use of non-pharmacologic options for pain relief in people that are 
tackling the difficult task of managing their pain to continue with their normal lives.  
As mentioned previously, one of the most common reasons people seek medical 
care is chronic pain;1 however, subclinical pain (mild, low irritability) generally does 
not prompt people to seek medical treatment.12,13,14 Subclinical pain can be measured 
by the visual analog scale (VAS) score of ≤3.4/10.15 In addition, non-pharmacological 
treatments in physical therapy for chronic subclinical pain have not been studied 
extensively.  Pain can lead to anxiety (which is often treated with pharmacological 
interventions) and avoidance of movement.8,9 Pain and local inflammation in the 
cervical spine or upper quadrant, coupled with avoidance of movement, can lead to 
reduced cervical spine proprioception. Pain and anxiety are often treated with 
pharmacological interventions. 
We are interested in learning more about people living with “subclinical” pain. 
According to Grant et al and Browne et al.16,17 people with neck pain but are not yet 
receiving any treatment as having minor musculoskeletal or “subclinical” pain. 

 
 
5
Subclinical pain may increase anxiety18,19 and affect movement and can lead 
to anxiety, disability, and impaired neck proprioception.12,14,20,21 
People may as what those non-pharmacologic options that physical therapy can 
offer for pain management, especially for untreated subclinical pain? In the field of 
physical therapy biophysical agents are agents that apply forms of energy to 
“modulate or decrease pain” along with the reduction of “risk factors and 
complications; enhance health, wellness, or fitness; enhance or maintain physical 
performance; or prevent or remediate impairments in body functions and structures, 
activity limitations, or participation restrictions.”22 Within the group of biophysical 
agents is the application and use of electrical currents, more specifically  
transcutaneous electrical nerve stimulation (TENS).22 
TENS is the delivery of electrical current through intact skin to stimulate 
peripheral nerves.23 TENS delivers electrical currents through the skin with the 
objective to stimulate peripheral nerves to prevent the transmission of nociceptive 
information to the brain and by this process achieve pain relief.24,25,26,27 One of the 
most accepted theories for the modulation of pain with the use of TENS is the “gate 
control theory of pain” by Melzack and Wall published in 1965.28,29 which explains 
pain relief by electrical stimulation.28 The authors proposed that by using electrical 
currents to stimulate low-threshold A-beta axons, it will reduce pain by pre-venting 
the transmission of nociceptive information in the spinal cord and brainstem.23 This 
theory also proposed that the substantia gelatinosa (SG) in the dorsal horn of the spine 
acts as a gate control system before afferents influence T cells.28 T cells then activate 
the system responsible for response and perception.28 Large-diameter afferent nerve 
fibers (facilitates SG) and small-diameter afferent nerve fibers (inhibits SG) influence 
T cells.30 TENS gives the clinician the option to select the depolarization of afferents 
nerves through the adjustment of parameters of electrical current deliver with 
electrodes through the skin.30 Depolarizing large-diameter (A-beta) sensory afferent 
nerves via sensory TENS can help gate or block noxious input.30,31,32  TENS has been 
used for treating subclinical pain based on studies that have found superiority of 
TENS over placebo for chronic musculoskeletal pain.33 Most importantly for our 
study, TENS is non-prescriptive battery-powered device that uses self-adhering 
electrodes on the surface of the skin to deliver electrical current. TENS is often self-
administered, affordable and safe when compared to medications.23 

 
 
6
Despite electrical stimulation for pain modulation has been used for many years, 
there is an “efficacy-impasse” for clinical utilization of TENS, despite fifty years of 
published research.34 There is an urgent need for randomized controlled trials to 
investigate TENS effectiveness.34 Based on this need the purpose of this study is to 
investigate the effects of electrotherapy for improving cervical spine proprioception, 
reduce pain, anxiety, and disability in adults with subclinical neck or upper quadrant 
pain. 
b. Objectives.  
1) To measure the immediate and short-term effects of TENS on subclinical neck or 
upper quadrant pain with the VAS, anxiety with the State-Trait Anxiety Inventory for 
Adults™, disability with neck disability index (NDI), disability and cervical spine 
proprioception Noraxon 3D Inertial Motion Capture System in subjects 20-40 years 
of age. 
2) To measure pain, anxiety, disability, and cervical spine proprioception in subjects 
with and without neck or upper quadrant pain. 
3) To compare compliance of TENS home usage in groups with and without short 
message system (SMS), text message, reminders. 
c. Procedures involved (Research Interventions) 
There will be three groups as follows: twenty subjects with no pain in the normal 
group; forty subjects with chronic subclinical neck or upper quadrant pain will be 
randomized into two groups: twenty subjects in the control group, and twenty 
subjects in the intervention group. The intervention group will be further randomized 
into two groups: ten subjects will receive instructions for home use of TENS with 
daily SMS text message reminders and ten subjects will receive instructions for home 
use of TENS without SMS text message reminders. We will aim for an equal 
distribution of males and females in each group. 
 
First session (Day 1): Before starting the procedures, participants complaining of pain 
that are greater than 4/10 in the VAS will be excluded from the study as this will be 
greater of what we consider to be subclinical pain based on literature review and if 
the pain has been present less than three months. In addition, if participants with pain 
less than 4/10 pain receiving clinical pain treatment, have taken pain medication 

 
 
7
within six hours of first session, have acute pain or contraindications for electrical 
stimulation would be excluded from the study.  Following completion of the signing 
procedures, all participants will be given brief explanations before administration of 
the questionnaires. 
First, participants in the normal group (20 subjects) will first be instructed to 
complete the VAS for pain, a subjective measure of pain intensity consisting of a 10 
centimeter (cm) line with anchor statements on the left (no pain) and extreme pain on 
the right. Pain scores will be determined by measuring the distance in cm from “no 
pain” to the participant’s anchor point. In this group the score must be “no pain” or 0 
cm.Participants randomly assigned to the control group (20 subjects) will first be 
instructed to complete the VAS for pain with a score less than 4/10 required. 
Participants randomly assigned to the intervention group (10 subjects) that will 
receive daily SMS text message reminders for compliance during intervention will 
first be instructed to complete the VAS for pain with a score less than 4/10 required. 
Participants randomly assigned to the intervention group (10 subjects) that will not 
receive daily SMS text message reminders for compliance during intervention will 
first be instructed to complete the VAS for pain with a score less than 4/10 required. 
Next, all participants in all groups will complete 2 self-report questionnaires 
beginning with the STAI-form Y which is a definitive clinical measure of state and 
trait anxiety in adults. Form Y has 20 items for assessing trait anxiety and 20 for state 
anxiety. All items are rated on a 4-point scale (e.g., from “Almost Never” to “Almost 
Always”). Higher scores indicate greater anxiety. 
Next, all participants in all groups will complete the NDI questionnaire which 
consist of 10 sections (pain intensity, personal care, lifting, work, headaches, 
concentration, sleeping, driving, reading and recreation) with questions that are 
measure in a 6-point scale from 0 (no disability) to 5 (full disability). The numeric 
responses will be added with a score varying from 0-50 where 0 is considered “no 
activity limitation” and 50 is considered “complete disability.” Furthermore, 0-4 (no 
disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe 
disability) and greater than 35 (complete disability). 
Next, all participants in all groups will be familiarized with the Noraxon 
myoMotionTM system instrument that utilizes inertial measurement units (IMUs) to 

 
 
8
measure angles of motion in joints which will measure cervical spine proprioception 
utilizing the joint position error (JPE) test. 
Participants in the normal group will not receive any interventions in the lab or at 
home and will not receive education on the use of TENS equipment. 
Participants in the control group will not receive any interventions in the lab or at 
home and will not receive education on the use of TENS equipment. 
Participants in the intervention group with daily SMS text message reminders will 
be provided with a TENS unit by the investigators for home use for a total of 29 days 
and instructed by a license physical therapist for its use and safety. In addition, you 
will be provided with a daily log sheet to track its use while receiving SMS text 
message reminders for compliance. Then, the participants in this intervention group 
will receive a 30-minute high-frequency sensory TENS treatment in lab on the pain 
site in the neck and upper quadrant area. After the 30-minute high-frequency sensory 
TENS treatment, the participants in the intervention group will again complete the 
VAS, STAI, and NDI. Also, cervical spine proprioception will be measured with 
Noraxon myoMotionTM system instrument utilizing the JPE test.  
Participants in the intervention group without daily SMS text message reminders 
will be provided with a TENS unit by the investigators for home use for a total of 29 
days and instructed by a license physical therapist for its use and safety. In addition, 
you will be provided with a daily log sheet to track its use without receiving SMS text 
message reminders for compliance. Then, the participants in this intervention group 
will receive a 30-minute high-frequency sensory TENS treatment in lab on the pain 
site in the neck and upper quadrant area. After the 30-minute high-frequency sensory 
TENS treatment, the participants in the intervention group will again complete the 
VAS, STAI, and NDI. Also, cervical spine proprioception will be measured with 
Noraxon myoMotionTM system instrument utilizing the JPE test.  
 
Session 2 (1st follow up) (Day 8): Participants will return on day eight. Participants in 
the normal group will be asked to complete again complete the VAS, STAI, and NDI. 
Also, cervical spine proprioception will be measured with Noraxon myoMotionTM 
system instrument utilizing the JPE test. Participants will not receive any 
interventions in the lab.  
Participants in the control group will be asked to complete again complete the 
VAS, STAI, and NDI. Also, cervical spine proprioception will be measured with 

 
 
9
Noraxon myoMotionTM system instrument utilizing the JPE test. Participants will 
not receive any interventions in the lab. 
Participants in the intervention group with daily SMS text message reminders will 
be asked to complete again complete the VAS, STAI, and NDI. Also, cervical spine 
proprioception will be measured with Noraxon myoMotionTM system instrument 
utilizing the JPE test. Participants will not receive any interventions in the lab. 
Participants in the intervention group without daily SMS text message reminders 
will be asked to complete again complete the VAS, STAI, and NDI. Also, cervical 
spine proprioception will be measured with Noraxon myoMotionTM system 
instrument utilizing the JPE test. Participants will not receive any interventions in the 
lab. 
 
Phone/Email follow up:  Participants in the normal, control and intervention (with no 
SMS text message reminders) groups will be contacted by e-mail and SMS text 
message during the seventh day period at least one before returning for session two 
on the eight day and at least three times before returning for the last session on day 
thirty. 
Participants in the intervention group (with SMS text reminders for compliance) 
will be contacted via SMS text message daily for compliance with high-frequency 
sensory TENS during the seven-day period before session two and during the twenty-
one-day period before last session. We will send a text message to the personal 
phone. Investigators will be available through phone, text message or email to answer 
any questions participants may have.  
 
Last session (Day 30): Participants will return on day thirty. Participants in the 
normal group will be asked to complete again complete the VAS, STAI, and NDI. 
Also, cervical spine proprioception will be measured with Noraxon myoMotionTM 
system instrument utilizing the JPE test. Participants will not receive any 
interventions in the lab and will be given a $50 gift card. 
Participants in the control group will be asked to complete again complete the 
VAS, STAI, and NDI. Also, cervical spine proprioception will be measured with 
Noraxon myoMotionTM system instrument utilizing the JPE test. Participants will 
not receive any interventions in the lab and will be given a $50 gift card. 

 
 
10
Participants in the intervention group with daily SMS text message reminders will 
be asked to complete again complete the VAS, STAI, and NDI. Also, cervical spine 
proprioception will be measured with Noraxon myoMotionTM system instrument 
utilizing the JPE test. They will return the TENS unit and the daily log sheet to the 
investigators. Participants will not receive any interventions in the lab. and will be 
given a $50 gift card. 
Participants in the intervention group without daily SMS text message reminders 
will be asked to complete again complete the VAS, STAI, and NDI. Also, cervical 
spine proprioception will be measured with Noraxon myoMotionTM system 
instrument utilizing the JPE test. They will return the TENS unit and the daily log 
sheet to the investigators.  Participants will not receive any interventions in the lab. 
and will be given a $50 gift card. 
d. Alternative procedures, if any, that are not included in the study but might be 
advantageous to the subject.  
n/a 
e. Concise review of literature that supports the rationale, objectives, and 
methodology of the proposed study.  
As defined by the IASP pain is “an unpleasant sensory and emotional experience 
associated with, or resembling that associated with, actual or potential tissue 
damage.” (IASP, 2021) and one of the most common reasons people seek medical 
care is chronic pain. Approximately 50 million adults in United Stated have chronic 
pain affecting daily lives1 posting public health problems in costs of pharmacological 
management.2,3 The financial cost to care for people with chronic pain is more costly 
than diabetes, cardiovascular and cancer combined.4,5 
Chronic pain is persistent or recurrent pain that last longer than 3 months in one 
or more locations in the body even beyond the period of the expected healing 
phase.6,7 Chronic pain can be affected by biological, psychological and social factors 
that are accompanied by anxiety, depression, frustration, deconditioning, functional 
disability, financial problems and opioid use problems.8,9 As people experience pain, 
that experience and manifestation of pain is unique to each individual and includes 
physical and psychological factors7 making the managing pain and chronic pain can a 
difficult thing to achieve.1  

 
 
11
Facing an opioid epidemic, the CDC reports that studies of 2 weeks to 6 months 
in duration that utilized effective non-pharmacological treatments for chronic pain 
were effective.10 Among the recommendations from the CDC for non-opioid and non-
pharmacological treatments for pain, physical therapy is included.10,11 As physical 
therapists we find imperative to reinforce the use of non-pharmacologic options 
for pain relief in people that are tackling the difficult task of managing their pain to 
continue with their normal lives.  
As mentioned previously, one of the most common reasons people seek medical 
care is chronic pain;1 however, subclinical pain (mild, low irritability) generally does 
not prompt people to seek medical treatment12,13,14 Subclinical pain can be measured 
by the VAS score of ≤3.4/10.15 In addition, non-pharmacological treatments in 
physical therapy for chronic subclinical pain have not been studied extensively.  Pain 
can lead to anxiety8,9 (which is often treated with pharmacological interventions) and 
avoidance of movement. Pain and local inflammation in the cervical spine or upper 
quadrant, coupled with avoidance of movement, can lead to reduced cervical spine 
proprioception. Pain and anxiety are often treated with pharmacological interventions. 
We are interested in learning more about people living with “subclinical” pain. 
According to Grant et al and Browne et al.16,17 people with neck pain but are not yet 
receiving any treatment as having minor musculoskeletal or “subclinical” pain. 
Subclinical pain may increase anxiety18,19 and affect movement and also can lead 
to anxiety, disability and impaired neck proprioception12,14,20,21 
People may as what those non-pharmacologic options that physical therapy can 
offer for pain management, especially for untreated subclinical pain? In the field of 
physical therapy biophysical agents are agents that apply forms of energy to 
“modulate or decrease pain” along with the reduction of “risk factors and 
complications; enhance health, wellness, or fitness; enhance or maintain physical 
performance; or prevent or remediate impairments in body functions and structures, 
activity limitations, or participation restrictions.”22 Within the group of biophysical 
agents is the application and use of electrical currents, more specifically  TENS.22 
TENS is the delivery of electrical current through intact skin to stimulate 
peripheral nerves.23 TENS delivers electrical currents through the skin with the 
objective to stimulate peripheral nerves to prevent the transmission of nociceptive 
information to the brain and by this process achieve pain relief.24,25,26,27 One of the 

 
 
12
most accepted theories for the modulation of pain with the use of TENS is the “gate 
control theory of pain” by Melzack and Wall published in 1965.28,29 which explains 
pain relief by electrical stimulation.28 The authors proposed that by using electrical 
currents to stimulate low-threshold A-beta axons, it will reduce pain by pre-venting 
the transmission of nociceptive information in the spinal cord and brainstem.23 This 
theory also proposed that the SG in the dorsal horn of the spine acts as a gate control 
system before afferents influence T cells.28 T cells then activate the system 
responsible for response and perception.28 Large-diameter afferent nerve fibers 
(facilitates SG) and small-diameter afferent nerve fibers (inhibits SG) influence T 
cells.30 TENS gives the clinician the option to select the depolarization of afferents 
nerves through the adjustment of parameters of electrical current deliver with 
electrodes through the skin.30 Depolarizing large-diameter (A-beta) sensory afferent 
nerves via sensory TENS can help gate or block noxious input.30,31,32   TENS has been 
used for treating subclinical pain based on studies that have found superiority of 
TENS over placebo for chronic musculoskeletal pain.33 Most importantly for our 
study, TENS is non-prescriptive battery-powered device that uses self-adhering 
electrodes on the surface of the skin to deliver electrical current. TENS is often self-
administered, affordable and safe when compared to medications.23 
Despite electrical stimulation for pain modulation has been used for many years, 
there is an “efficacy-impasse” for clinical utilization of TENS, despite fifty years of 
published research.34 There is an urgent need for randomized controlled trials to 
investigate TENS effectiveness.34 Based on this need the purpose of this study is to 
investigate the effects of electrotherapy for improving cervical spine proprioception, 
reduce pain, anxiety, and disability in adults with subclinical neck or upper quadrant 
pain. 
f. If an Investigational Device (ID) is involved, provide the following information: 
(1) name of device, (2) manufacturer, (3) status with Food and Drug 
Administration and ID#, (4) review of animal studies and previous human 
studies, (5) reported adverse effects.  
n/a 
 
9. 
DATA COLLECTION 
The study will be conducted in the Neuroscience Research Laboratory in the SAHP- 
Room NH A-712, Loma Linda, California. Informed consent will be obtained prior to 

 
 
13
the beginning of the study by the graduate student investigator and other IRB 
approved researchers. Participants will be recruited if they are adults (males and 
females) aged 20-40 years old with no pain for the normal group and with neck or 
upper quadrant pain no greater than 4/10 in the VAS for longer than three months, not 
receiving clinical pain treatment, have not taken pain medication within six hours of 
first session, have acute pain or contraindications for TENS. 
Study participants will be assessed on visits one, two and three (visit three will be at 
the end of the thirty-day period).  
During participant’s visit one, two and three the following clinical assessments will 
be provided:  
- The VAS for pain, a subjective measure of pain intensity 
- The STAI-form Y is a definitive clinical measure of state and trait anxiety in adults. 
- The NDI questionnaire that measures neck disability. 
- JPE test which will measure cervical spine proprioception through the Noraxon 
myoMotionTM system instrument. 
 
10. 
LABELING & STORAGE OF DATA & SPECIMENS 
Hard copies will be stored in a locked file cabinet in a locked room in the clinic and 
computer data will be stored on an encrypted computer in a locked room in the clinic.  
 
11. 
DATA ANALYSIS 
All data will be analyzed using SPSS version 28.0. For quantitative data, we will use 
the statistical test ANOVA and for descriptive statistics we will use means and 
standard deviations. Also, an expert statistician will be consulted to accurately 
analyze and interpret the results. The alpha level will be set at 0.05. 
 
12. 
RISK AND INJURY 
Participating in this study will involve the following risks:  this study may involve 
breach of your confidentiality, risk of falls, risk of fatigue during study procedures 
and discomfort with the application of pain reducing electrical stimulation. This study 
may involve breach of your confidentiality: your information will be kept in a locked 
cabinet, in a locked office and store on a secure drive. Risk of falls: all reasonable 
attempts will be made to prevent you from falling including supervision, as someone 
will stand closely beside you to provide you with physical assistance as needed, the 
floor in the neuroscience research laboratory is not slippery. Risk of fatigue during 

 
 
14
study procedures: you will be offered rest breaks regularly if the investigators notice 
signs of fatigue on you. You will be instructed on the use and application of pain 
reducing electrical stimulation device.  
 
13. 
BENEFIT(S) 
We expect that participants will experience improvements in cervical spine range of 
motion and proprioception, decreased anxiety and neck disability, and all components 
of improving wholeness and health as participants carry out functional activities. The 
expected benefits of this study include the improve of quality of life and functional 
mobility in people with neck chronic pain. In addition, the study may provide 
evidence of the efficacious use of electrical stimulation as a non-pharmacological 
option for the management of chronic pain. This study is expected to provide through 
electrical stimulation an accessible, affordable, self-administered and non-
pharmacological option for the management of chronic pain without the need to go to 
a clinic for the application of electrical stimulation. 
 
14. 
COMPENSATION 
Participants will receive a $50 gift card at the completion of the study. 
 
15. 
CONFIDENTIALITY 
Efforts will be made to keep participants’ personal information confidential, but we 
cannot guarantee absolute confidentiality. We will use a pseudonym throughout the 
study for all recorded data so participant’s actual name will not be used. Participants 
will not be identified by name in any publications describing the results of this study. 
Data in hard copy will be kept in a locked file cabinet, in a locked office and 
electronic data will be stored on a secure drive and password protected. 
 
16. 
LITERATURE REVIEW 
As defined by the IASP pain is “an unpleasant sensory and emotional experience 
associated with, or resembling that associated with, actual or potential tissue 
damage.” (IASP, 2021) and one of the most common reasons people seek medical 
care is chronic pain. Approximately 50 million adults in United Stated have chronic 
pain affecting daily lives1 posting public health problems in costs of pharmacological 
management.2,3 The financial cost to care for people with chronic pain is more costly 
than diabetes, cardiovascular and cancer combined.4,5 

 
 
15
Chronic pain is persistent or recurrent pain that last longer than 3 months in one 
or more locations in the body even beyond the period of the expected healing 
phase.6,7 Chronic pain can be affected by biological, psychological and social factors 
that are accompanied by anxiety, depression, frustration, deconditioning, functional 
disability, financial problems and opioid use problems.8,9 As people experience pain, 
that experience and manifestation of pain is unique to each individual and includes 
physical and psychological factors7 making the managing pain and chronic pain can a 
difficult thing to achieve.1  
Facing an opioid epidemic, the CDC reports that studies of 2 weeks to 6 months 
in duration that utilized effective non-pharmacological treatments for chronic pain 
were effective.10 Among the recommendations from the CDC for non-opioid and non-
pharmacological treatments for pain, physical therapy is included.10,11 As physical 
therapists we find imperative to reinforce the use of non-pharmacologic options 
for pain relief in people that are tackling the difficult task of managing their pain to 
continue with their normal lives.  
As mentioned previously, one of the most common reasons people seek medical 
care is chronic pain;1 however, subclinical pain (mild, low irritability) generally does 
not prompt people to seek medical treatment.12,13,14 Subclinical pain can be measured 
by the VAS score of ≤3.4/10.15 In addition, non-pharmacological treatments in 
physical therapy for chronic subclinical pain have not been studied extensively.  Pain 
can lead to anxiety8,9 (which is often treated with pharmacological interventions) and 
avoidance of movement. Pain and local inflammation in the cervical spine or upper 
quadrant, coupled with avoidance of movement, can lead to reduced cervical spine 
proprioception. Pain and anxiety are often treated with pharmacological interventions. 
We are interested in learning more about people living with “subclinical” pain. 
According to Grant et al and Browne et al.16,17 people with neck pain but are not yet 
receiving any treatment as having minor musculoskeletal or “subclinical” pain. 
Subclinical pain may increase anxiety18,19 and affect movement and also can lead 
to anxiety, disability and impaired neck proprioception.12,14,20,21 
People may as what those non-pharmacologic options that physical therapy can 
offer for pain management, especially for untreated subclinical pain? In the field of 
physical therapy biophysical agents are agents that apply forms of energy to 
“modulate or decrease pain” along with the reduction of “risk factors and 

 
 
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complications; enhance health, wellness, or fitness; enhance or maintain physical 
performance; or prevent or remediate impairments in body functions and structures, 
activity limitations, or participation restrictions.”22 Within the group of biophysical 
agents is the application and use of electrical currents, more specifically  TENS.22 
TENS is the delivery of electrical current through intact skin to stimulate 
peripheral nerves.23 TENS delivers electrical currents through the skin with the 
objective to stimulate peripheral nerves to prevent the transmission of nociceptive 
information to the brain and by this process achieve pain relief.24,25,26,27 One of the 
most accepted theories for the modulation of pain with the use of TENS is the “gate 
control theory of pain” by Melzack and Wall published in 1965.28,29 which explains 
pain relief by electrical stimulation.28 The authors proposed that by using electrical 
currents to stimulate low-threshold A-beta axons, it will reduce pain by pre-venting 
the transmission of nociceptive information in the spinal cord and brainstem.23 This 
theory also proposed that the SG in the dorsal horn of the spine acts as a gate control 
system before afferents influence T cells.28 T cells then activate the system 
responsible for response and perception.28 Large-diameter afferent nerve fibers 
(facilitates SG) and small-diameter afferent nerve fibers (inhibits SG) influence T 
cells.30 TENS gives the clinician the option to select the depolarization of afferents 
nerves through the adjustment of parameters of electrical current deliver with 
electrodes through the skin.30 Depolarizing large-diameter (A-beta) sensory afferent 
nerves via sensory TENS can help gate or block noxious input.30,31,32 TENS has been 
used for treating subclinical pain based on studies that have found superiority of 
TENS over placebo for chronic musculoskeletal pain.33 Most importantly for our 
study, TENS is non-prescriptive battery-powered device that uses self-adhering 
electrodes on the surface of the skin to deliver electrical current. TENS is often self-
administered, affordable and safe when compared to medications.23 
Despite electrical stimulation for pain modulation has been used for many years, 
there is an “efficacy-impasse” for clinical utilization of TENS, despite fifty years of 
published research.34 There is an urgent need for randomized controlled trials to 
investigate TENS effectiveness.34 Based on this need the purpose of this study is to 
investigate the effects of electrotherapy for improving cervical spine proprioception, 
reduce pain, anxiety, and disability in adults with subclinical neck or upper quadrant 
pain. 

 
 
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