Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction
Phase: NA
Conditions: Tennis Elbow
Sponsor: Guided Therapy Systems

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
Page 1 of 35
Protocol V11 May 4, 2015 
PROTOCOL 
TITLE: STUDY TO EVALUATE THE SAFETY, EFFICACY AND TOLERANCE OF INTENSE 
THERAPUETIC 
ULTRASOUND 
(ITU) 
FOR 
THE 
TREATMENT 
OF 
LATERAL 
EPICONDYLOSIS 
Guided Therapy Systems 
33 Sycamore St. 
Mesa, AZ 85202
Primary Contact; 
For The MORE Foundation 
Name: 
 John Kearney, MD 
Telephone: 
623-537-5600 (24 hours)
Email:  
john.kearney@thecoreinstitute.com 
For Guided Therapy Systems 
Name: 
Michael H. Slayton Ph.D 
Telephone: 
480-649-4399
Email: 
m.slayton@guidedtherapy.com
CONFIDENTIAL 
Confidential information in the following document is provided to you as an investigator, 
potential investigator or consultant for review by you and your staff. By accepting this 
document, you agree that information contained herein will not be disclosed to others without 
written authorisation from Guided Therapy System except to the extent necessary to obtain 
informed consent from subjects considering participation in the study. This document may 
also be disclosed to an Independent Ethics Committee or Institutional Review Board or 
authorised representatives of national regulatory authorities under the condition that they 
respect its confidential nature. 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
Page 2 of 35
Protocol V11 May 1, 2015 
Approval of the Protocol 
I have thoroughly read and reviewed the study protocol. This study will be conducted in 
compliance with the protocol, the Declaration of Helsinki, principles of Good Clinical Practice and 
any applicable regulatory requirement(s). 
PRINCIPAL INVESTIGATOR 
Signature:  ....................................................  
Date: .................................................... 
Name (printed): John A. Kearney, Jr., MD
Title (printed): 
SPONSOR - GUIDED THERAPY SYSTEMS 
Signature:  ....................................................  
Date: .................................................... 
Name (printed): Michael H. Slayton, Ph.D. 
Title (printed):    President and CEO 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
Page 3 of 35 
        Protocol V11 May 1, 2015 
 
  
CONTACTS 
Sponsor 
Guided Therapy Systems.   33 South Sycamore, Mesa, AZ 85202. 
 
Michael Slayton, Ph.D. 
Guided Therapy Systems.    
33 South Sycamore St., Mesa, AZ 85202. 
 
MONITORS  
Name: Elizabeth Gleason, M.A., CCRC 
Title: Manager, Clinical Research 
Name of Study Site: The MORE Foundation® Address of Study Site: 
18444 N. 25th Ave. Suite 110, Phoenix, AZ 85023 
Telephone number(s): 623.537.5695 
Email:   
 
Michael Slayton, Ph.D. 
Guided Therapy System.  
33 South Sycamore Mesa, AZ 85202 USA  
(phone) 480.649.4399  
PRINCIPAL 
INVESTIGATOR 
Name: John Kearney, MD 
Title: Principal Investigator 
Name of Study Site: The MORE Foundation® 
Address of Study Site: 18444 N. 25th Ave. Suite 110, Phoenix, AZ 
85023 
Telephone number(s): 623-537-5695 
Email:  john.kearney@thecoreinstitute.com 
REPORTING OF 
ADVERSE 
EVENTS 
Name: John Kearney, MD 
Title: Principal Investigator 
Company name: The MORE Foundation® 
Company address: 18444 N. 25th Ave. Suite 110, Phoenix, AZ 85023 
Telephone number(s): 623-537-5695 
Email:  john.kearney@thecoreinstitute.com 
 
 
 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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Protocol V11 May 1, 2015 
INTRODUCTION 
Acute and Chronic pain of the Common Extensor Tendon (CET) region, or lateral 
epicondylitis/lateral epicondylalgia, or tennis elbow is a common pathology of both 
athletes and non-athletes affecting 1 to 3 % of the population at large.1,2 The 
prevalence of chronic problems caused by overuse in tennis players can be as high 
as 40%.15 Elbow tendinopathy represents an important set of pathologies that 
account for lost recreation time, decreased quality of life, and work-related disability 
claims. As an example, medial and lateral epicondylitis was responsible for 11.7% of 
work-related injury claims in Washington State from 1987 to 1995, resulting in an 
average direct workers’ compensation cost of $6,593 per case.16 Elbow tendinopathy 
has widespread social, financial, and clinical implications. Walker-Bone et al2
assessed the effect of medial and lateral epicondylitis on workplace absences in a 
cross-sectional sample of 9,696 working-aged adults. Five percent of patients 
reported taking a sick day due to their elbow pain within the preceding year. 
This condition is most often associated with overuse or a repetitive stress, as 
opposed to an acute inflammatory reaction. The lack of pathological evidence of 
inflammation in these types of injuries has lead most authors to now refer to this 
condition as an Epicondylosis, abandoning the mislabelled “itis”.3–5
Diagnostic Ultrasound has been used to evaluate musculoskeletal anatomy and 
pathology since the early 1990’s. Ultrasound imaging can be used to evaluate the 
structure of the Common Extensor tendons, evidence of microtears, partial and full 
ruptures, and hypoechoic lesions in and about the tendon and peritendinous lesions9.
Common Extensor Tendon thickness can change with age10, and should be a useful 
tool in tracking tendon improvement during a long treatment period.
Conservative treatment of the Epicondylitis or osis is recommended as the initial 
strategy by most authors. This strategy includes identification and correction of 
possible etiological factors, and a symptomǦrelated approach. Generally, the initial 
treatment consists of a multifactorial approach that may include a combination of rest 
(complete or modified activity), medication (NSAIDs for Epicondylitis), stretching and 
strength training9.
Intense Therapeutic Ultrasound (ITU) is a novel potential treatment for CET 
Tendinosis. ITU is a highly focused ultrasound wave that delivers enough energy 
intensity to disrupt soft tissues within a controlled up to 1 mm3 volume, while sparing 
surrounding tissue structures. Much like a laser is formed by focusing light to 
concentrate energy over a small area, ultrasound can emit sound waves that can 
propagate through tissues to deliver selective thermal coagulative changes while 
leaving the surrounding tissue unaffected.11,12,13
ITU has been used clinically for treating the facial soft tissue for the past decade 
and it has received FDA approval for non-surgical brow and submental lifting. 
Over 300,000 treatments have been performed with this technology.  Clinical 
studies in 2005/2006 (IRB#’s 05-06-032, 1253-014) using intense therapeutic 
ultrasound (ITU) on facial soft tissue whereby the energy is focused underneath 
the skin tissue to achieve controlled coagulative necrosis (~1 mm3) were 
performed. Seventy subjects were involved in the studies and 84% of subjects 
showed an improvement in facial lifting with no significant pain, erythema, 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
inflammation, or scarring11,12. Slight edema and erythema were noted on some 
subjects, all resolving within 30 minutes after treatment.  
 
Histologically, it has been proven that ITU induces greater dermal collagen with 
thickening of the dermis and straightening of elastic fibers in the reticular dermis11-
15. Due to the proven clinical performance, there is current ongoing research that 
is specifically designed to determine whether ITU can improve healing of 
damaged Achilles tendon in a rabbit model15. The main goal of the project was to 
determine if ITU accelerates the healing process, and/or promotes a response 
that leads to superior structural and mechanical properties of tendon.  Preliminary 
results from the rabbit research at day 4 post treatment showed an increase in 
Vascular Endothelial Cell Growth Factor A (VEGFa), Tumor Necrosis Factor 
Alpha (TNFα), Interleukin 1-Beta (IL-1β), and Transforming Growth Factor Beta 1 
(TGFβ1) and a decrease in Collagen Type 1 Alpha 1(COL1α1), and Collagen 
Type 1 Alpha 2(COL1α2) in the damaged and ITU treated legs.  
 
At 14 days post treatment PCR showed an increase in Collagen Type 1 Alpha 1 
(COL1a1) and Collagen Type 1 Alpha 2 (COL 1a2), as well as an increase in 
Vascular Endothelial Cell Growth Factor A (VEGFa), Tumor Necrosis Factor 
Alpha (TNFα), Interleukin 1-Beta (IL-1β), and Transforming Growth Factor Beta 1 
(TGFβ1), in the injured rabbit tendon treated with ITU compared to injured, 
untreated rabbit tendon15.  These results led us to explore the possibility of 
performing a clinical trial assessing the effectiveness of ITU in actual patients with 
CET Tendinosis. 
 
The purpose of this trial is evaluate the tolerability and efficacy of an ITU device to 
treat CET tendinosis as measured by Subject Self-assessment survey of pain17, 
function, and activity (Patient Rated Tennis Elbow Evaluation (PRTEE18), Diagnostic 
Ultrasound Imaging, to evaluate tendon thickness, homogeneity, and gross 
anatomy/pathology, and physical examination.  
 
ULTRASOUND THERAPY BACKGROUND  
 
i. 
Historical Background 
 
Ultrasound is an energy modality that can propagate to deeper layers of tissue 
while sparing the skin surface. The energy created from intense focused 
ultrasound (ITU) can be focused into deep tissue layers to achieve controlled 
coagulative necrosis (≤ 1 mm3).  
 
ii. 
Previous Ultrasound Research 
 
Ulthera® Studies 
 
Clinical studies in 2005/2006 (IRB#’s 05-06-032, 1253-014) using intense 
therapeutic ultrasound (ITU) on facial soft tissue whereby the energy is 
focused underneath the skin tissue to achieve controlled coagulative necrosis 
(~1 mm3) were performed. Seventy subjects were involved in the studies and 
84% of subjects showed an improvement in facial lifting with no significant 
pain, erythema, inflammation, or scarring10,11.  
 
In addition, more than 300,000 patients worldwide have been treated with the 
Ulthera device with no reportable adverse events.   

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
 
For these clinical studies, highly focused sources were used at 4.4 and 7.5 
MHz, at source power levels of 20 – 60 W. This sharply focused intense field 
was capable of achieving selective coagulative necrosis in sub-epidermal skin 
tissue and resulted in substantial improvement of the skin with no side effects. 
 
The Ulthera device has received FDA clearance for non-invasive lifting of the 
eyebrow, neck and submental regions (K121700).   
 
Pre-clinical 
 
Therapeutic application of ultrasound energy in skin tissue, has been 
extensively investigated by our group10-13. The selective thermal coagulation of 
skin tissue with directive ultrasound energy was demonstrated in vitro as well 
as in vivo. In order to comprehensively understand the ultrasound energy-skin 
tissue interaction, a wide range of ultrasound source geometries and source 
conditions were investigated during the pre-clinical research. The source 
frequencies investigated ranged from 4 – 10 MHz, whereby the source 
acoustic power ranged from 5 – 80 W.   
 
A summary and scope of the various pre-clinical studies is provided in the Table  
below.  
 
Table: Summary results of multiple exposures and effect on skin tissue using 
UltraSite STTM System 
 
Institute 
Tests 
Number of Exposures 
Goals Accomplished 
MEEI, Harvard Med. 
School, M White, MD, 
R. Gliklich, MD 
6 Human 
cadavers 
7.5 and 4.4 MHz 
probes 
>1000 exposures placed in 
facial skin tissue 
At least 200 sample shots 
assessed (NBTC + H&E 
staining) 
-- Define clinical 
procedure steps (skin 
marking, lesion 
identification, etc.) 
-- Verify treatment 
control, maximum 
depth, and dose 
response 
Wellman Labs, MGH, 
H.J. Laubach, MD  
Ex vivo human 
torso/back skin 
7.5 and 10 MHz 
probes 
>150 exposures  
All shots assessed (NBTC and 
Eosin counter-stain) 
-- Understand basic skin 
tissue effect (depth, 
dimension, control, etc.) 
with ultrasound 
-- Understand 
biophysical processes – 
selective thermal 
ablation and its 
predictability 
UC San Diego, R. 
Fitzpatrick, MD 
6 Human 
cadavers 
7.5, 4.4 and 10 
MHz probes 
>1000 exposures placed in 
facial skin tissue 
At least 300 samples assessed 
(H&E and Trichrome-Masson 
staining) 
-- Validate clinical 
treatment logistics (skin 
marking, lesion 
identification, etc.) 
-- Validate visual 
(clinical) effect of tissue 
shrinkage 
-- Verify treatment depth, 
control, and dose 
response 
-- Identify Trichrome-
Masson stain as a 
potential predictor of 
thermal damage with 
UltraSite STTM System 

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        Protocol V11 May 1, 2015 
 
Ulthera, Inc., 
I.R.S. Makin, MD. PhD, 
PG. Barthe, PhD, MH. 
Slayton, PhD  
Ex vivo porcine 
skin 
8 in vivo porcine 
abdominal skin 
experiments 
7.5, 4.4 and 10 
MHz probes 
>1000 exposures placed in 
porcine skin (in vivo and ex 
vivo) 
At least 70% of samples 
assessed histological (NBTC 
and H&E) 
-- Device and 
application 
development 
-- Correlate experiment 
with numerical 
simulations 
-- Understand skin-
ultrasound biophysics 
-- Confirm dose 
response 
 
In summary, safety and efficacy for the described above studies performed with 
intense therapeutic ultrasound (ITU) was demonstrated. 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
STUDY OBJECTIVES 
To evaluate the tolerance, efficacy and safety of an ultrasound therapy device to treat 
CET tendinosis as measured by: 
x 
Subject survey of pain, function, and activity: Patient Rated Tennis Elbow Evaluation 
(PRTEE). 
x 
Diagnostic Ultrasound Imaging, to evaluate tendon thickness, homogeneity, and 
gross anatomy/pathology. 
x 
Subject self-assessment of improvement, satisfaction and treatment tolerability. 
x 
Physician physical examination. 
STUDY DESIGN 
This will be a single center, controlled study involving a total of twenty-five (25) subjects 
with CET tendinosis (figure 2).  Subjects will receive two treatments. Each treatment will 
be up to ten minutes (10 minutes) in duration.   
 
 
 
 
 
 
 
Figure 1.  Study Design. 
 
 

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        Protocol V11 May 1, 2015 
 
STUDY OUTLINE 
 
This study will be approximately 2 months in duration plus 2 telephone surveys at 12 and 24 
weeks.  Subjects who meet the criteria and provide written consent to be in the study will be 
included in the study.   
 
Subjects will receive conservative standard of care treatment plus two ITU treatments (week 
0 and week 4) on the affected CET (figure 2) using the ultrasound therapy device.  
Treatments will be up to 10 minutes in duration.  A 2, 4, and 8 week follow up period will be 
included to monitor the effects of the therapy post treatment. A 12 and 24-26 week telephone 
assessments for the primary objectives will also be included. Telephone assessments will 
consist of the subjects answering the survey questions over the phone. 
 
Subject self-assessments will be conducted before the treatment phase and during the 
follow-up period.  Physical exams will be completed by a physician. Physical therapy will 
completed by a therapist. ITU treatment and diagnostic ultrasound will be performed by 
Guided Therapy personnel as shown in the full schedule of events (Appendix 1). 
 
 
Figure 2: Treatment Area 
SELECTION OF SUBJECTS 
Planned number of subjects 
The study population will consist of up to 25 subjects with unilateral CET tendinosis 
defined as pain lasting more than 3 months with little or no improvement following 
conservative standard of care alone. 
The selection of suitable subjects will be made according to the inclusion and exclusion 
criteria described in the following sections. 
Inclusion Criteria 
 
1. Subjects who are in general good health and are willing to cooperate and participate 
by following study requirements for the duration of the study, and to report any adverse 
symptoms immediately; 
2. Subjects who have provided written and verbal informed consent; 
3. At time of enrollment subjects are between the ages of 21 and 65 years  
4. Subjects literate in English and able to complete all patient self-assessment 
questionnaires; 

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        Protocol V11 May 1, 2015 
 
5. Subjects is willing to refrain from  beginning any additional treatment during the 
duration of the study; 
6. Subjects is willing to refrain from changing physical activity during the duration of the 
study;   
7. Subjects diagnosed with unilateral CET tendinosis defined as pain lasting more than 
3 months with little or no improvement following conservative standard of care alone.  
8. Subjects with BMI ≤ 35 or at the discretion of the PI.  
9. Subjects must be able to sit in a chair with their arm on an appropriate table for the 
treatment and diagnostic ultrasound imaging.  
10. Subject must be able and willing to complete the at home therapy regimen. 
 
Exclusion Criteria 
Subjects with any of the following conditions are not eligible for participation: 
 
1. Subjects currently enrolled in any other device, or IND (Investigational New Drug) 
clinical trial, or who have participated in a clinical study involving the CET, thirty 
days prior to study initiation; 
2. Subjects who have participated in any other clinical study involving an 
investigational product 30 days prior to enrollment that, in the opinion of the 
Principal Investigator, could affect the outcome of this study;  
3. Subjects who have received any previous treatment in the symptomatic limb in 
the past 30 days timeframe (not including standard of care treatment);  
4. Subjects diagnosed with bilateral CET tendinopathy. 
5. Subjects who have had any previous difficulties or problems with wound healing, 
bruising, scarring or procedures involving medical devices; 
 
6. Subjects with diagnosed uncontrolled metabolic diseases, such as diabetes, 
hypertension, hyperthyroidism, and hypothyroidism as determined by the initial 
paperwork; 
7. Subjects known to be pregnant or nursing as determined by the initial paperwork; 
8. Subjects currently taking medications which, in the opinion of the Investigator, 
may interfere with the study (e.g., statins, prescription steroids, prescription anti-
inflammatory drugs, etc.). Subjects who have been on a stable dose of medication 
for a minimum of 3 months prior to the study start, and who agree to continue that 
dose of medication for the duration of the study may be allowed to participate at 
the Investigator’s discretion 
9. Subjects who have taken quinolone antibiotic in the past 3 months; 
10. Subjects with a diagnosed auto-immune disorder; 
11. Subjects with diagnosed fibromyalgia; 
12. Subjects with diagnosed peripheral neuropathy; 
13. Subjects that will not be available for on-site follow-ups as noted in the schedule. 
14. Subjects with previous CET tendon rupture in the symptomatic limb. 
15. Subjects with BMI > 35 or at the discretion of the PI  
 

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        Protocol V11 May 1, 2015 
 
Individuals will be admitted to study at the discretion of the investigator or designate 
based on medical history (eligibility paperwork) and findings of the pre-study interview 
and examination. 
Subject Restrictions  
Subjects must not change their physical activity during the course of the study. 
Subjects’ BMI must not increase to > 35 or at the discretion of the PI 
WITHDRAWAL OF SUBJECTS. 
Subjects may discontinue from the clinical study at any time. In addition, the Principal 
Investigator (PI) or designee has the right to withdraw a subject for any reason that is in the 
best interests of the subject. The subject must inform the Investigator immediately if they 
intend to withdraw. Subjects may be asked to come to the study facility to complete some end 
of study procedures. 
The Investigator can remove the subject from this study without their consent for any reason, 
including, but not limited to: 
o 
His/her judgment that any condition or circumstance may jeopardize their welfare or 
the integrity of the study. 
o 
Their failure to follow the instructions of the investigator(s) (protocol non-compliance) 
o 
Subject BMI exceeds ≥35 during the courses of the study. 
o 
If the study is stopped by GTS and/or Principal Investigator of the study prior to 
completion. 
CLINICAL ASSESSMENTS 
Assessment of Efficacy 
Primary: 
 
The primary endpoint(s) for efficacy and tolerability will be the total score of the 
PRTEE questionnaire (Appendix 2), subject self-assessment of improvement and 
satisfaction (SROM-Appendix 3-B), and Visual Analog Scale for Pain (VAS) or Universal 
Pain Assessment Tool (Appendix 3-C).  
 
Secondary: 
The secondary endpoint for efficacy will be a measured reduction in tendon thickness by 
diagnostic ultrasound, and a physical examination. 
 
 
PRTEE Questionnaire 
 
The PRTEE questionnaire (Appendix 2) evaluates three domains clinically relevant to 
patients (pain, function, and activity) and was specifically developed to assess the clinical 
severity of CET tendinopathy.  It is composed of 15 questions that cover 3 domains of pain 
(questions 1 through 5), function for specific activities (questions 6 through 11), and general 
activities (questions 12 through 15).  All questions are scored 0 – 10. Higher scores indicate 
more severe CET tendinopathy.  The PRTEE questionnaire has been validated and shows 
good test-retest reliability18  
 
 
Physical Examination  
 
 
Medical History: Review patient’s medical history questionnaire. Review any diagnostic 
imaging, tests, or work up listed under longitudinal medical record and centricity. Ask 
about possible trauma or history of injuries to the symptomatic arm. Review athletic 
history (tennis, golf, etc) and subject’s pre-study exercise regimen (if any). Height, Weight 
(BMI) will also be documented. 

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        Protocol V11 May 1, 2015 
 
 
History of Present Illness: Most common complaint is of elbow pain.  
 
Social Hx: Frequently found those involved in racquet sports.  
 
Medications: non-steroidal anti-inflammatory medications and corticosteroids.  
 
Pain: measured on the VAS scale; note activities that increase symptoms, decrease 
symptoms, and the location of symptoms.  
 
 Examination protocol is simple and will consist of the following: 
a. Skin examination (note any rashes, lesions, areas of skin irritation over the lateral 
elbow region) 
b. Palpation over the lateral epicondyle of affected side, note presence of 
tenderness to palpation vs. no tenderness to palpation 
c. Check range of motion of elbow in flexion, extension, pronation, and supination 
(may use normative template data that is in EMR under elbow exam) 
d. Check provocative tests for lateral epicondylitis and note whether or not these 
elicit pain that refers into the common extensor tendon.  The 2 provocative tests 
will be:  1. Resistance to active wrist extension.  2.  Resistance to active middle 
finger extension 
 
 
 
Ultrasound Imaging 
Ultrasound images will be collected from test sites on both the affected and unaffected 
CET using the Spark® High Frequency Ultrasound System. CET tendon thickness, 
homogeneity and gross assessment of the CET tendon and surrounding tissue will be 
conducted.  
 
Assessment of Safety 
 
Recording of Adverse Events or any other significant event will take place at all visits. 
Adverse events will be monitored throughout the study. (Appendix 5) 
ASSESSMENTS AT EACH VISIT 
An overview of the assessments to be conducted at each study visit are presented in a Table 
in Appendix 1.   
 
Subjects will be treated at Visit 1 and Visit 3.  Imaging will occur, before the treatments, and 
at visits 2, and 4. The PRTEE questionnaire will be administered, prior to the first treatment 
at visits 1 and 3, and at visits 2, and 4. An additional telephone follow-up, where answers to 
the questionnaires will be recorded, will occur at 12 and 24 weeks post treatment one (1) per 
the schedule in Appendix 1.   
The study will last approximately two (2) months with a follow-up phone call at three (3) and 
six (6) months. 
Visit 0 (Recruitment):  Screening and Enrollment  
1. Candidate subjects will read an informed consent (which includes a confidentiality 
agreement) and will sign (along with a witness) after all questions about the study 
have been answered. Individuals will be issued a temporary screening number. 
2. Eligibility paperwork will include documentation of pregnancy status and pertinent 
medical history.  
If a subject meets all the inclusion/ exclusion criteria, they will be enrolled onto the study, 
issued a subject number and an X-ray will be scheduled.  

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        Protocol V11 May 1, 2015 
 
Visit 1 and 3:  (Weeks 0 and 4) Study treatments 
1. Record AEs, con meds and other events 
2. Administer PRTEE-A questionnaire (Appendix 2) 
3. Subject self-assessment questionnaire (Appendix 3) 
4. Focused Physical Evaluation  
5. Diagnostic Ultrasound images taken 
6. ITU treatment, and VAS assessment of treatment tolerability. 
7. Physical Therapy will be performed as described (Appendix 4 – Visit 1 only) 
8. Home Cold Pack & Stretching Program review and Log (Appendix 6-A and 6-B) 
Visit 2, and 4:  (Weeks 2 and 8) Diagnostic Ultrasound, Self-Assessments, Physical 
Examination 
1. Record AEs, con meds and other events; 
2. Administer PRTEE-A questionnaire (Appendix 2) 
3. Subject self-assessment questionnaire (Appendix 3) 
4.  Diagnostic Ultrasound image taken; 
5. Home Cold Pack & Stretching Program review and Log (Appendix 6-A and 6-B) 
 
Phone/Online Interviews at 3 and 6 months post treatment 
1. Record AEs, con meds and other events; 
2. Follow-up phone interview PRTEE-A verbally administered (Appendix 2). 
3. Subject self-assessment questionnaire (Appendix 3) 
 
 
STUDY TREATMENT 
ITU will be performed by a trained technologist, using a clinical prototype (Ulthera FDA 
cleared in Sept. 2009) GEN II or GEN III designed Guided Therapy Systems, LLC. Mesa, AZ 
USA (Appendix 7-A). 
 
Subjects will be treated seated with their arm resting on a structure that is comfortable for the 
subject and technologist.  Transdermal application of ITU therapy: An average energy up to 3 
joules (0.5 to 3 J) will be administered to the affected CET tendon longitudinally until the 
maximum number of lines (12) are reached. Each line will include individual thermal zones, 
less than 1 mm3 in volume, centered at a depth between 2 – 6 mm, up to 2 mm apart (figure 
3).  
 
 
Treatment pattern: 
1-6 mm
1-2 mm
Ultrasound 
Probe 
Tendo
Te
Figure 3. Zone pitch, and depth. 

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        Protocol V11 May 1, 2015 
 
 
 
 
 
 
Acoustic Coupling Gel will be applied every 3-5 lines.  
 
The study treatment will be a 10 minute session using the ultrasound therapy device with 
coupling gel. Subjects will be treated seated with their arm resting on a structure that is 
comfortable for the subject and technologist.    
 
 
 
Tendon 
Treatment lines 
The study treatment will be a
Figure 3-1. Zone pitch, and depth. 

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        Protocol V11 May 1, 2015 
 
DIAGNOSTIC ULTRASOUND IMAGING 
 
Diagnostic Ultrasound Imaging will be performed by a trained Sonographer using the Spark® 
Imaging System, manufactured by Ardent Sound, Inc., Mesa, AZ USA (Appendix 7-B) 
 
Subjects will be imaged seated with their arm resting on a structure that is comfortable for 
the subject and sonographer.  
 
PolySonic® or AquaSonic® Gel will be applied by the sonographer as required to maintain 
adequate acoustic coupling. (Appendix 7-C) 
I 
Images will be preserved with the following notations: 
 
x 
Protocol ID 
x 
Right vs. Left CET Tendon 
x 
Treated vs. Untreated 
 
Long Axis and Short Axis (if necessary) images will be stored at the Sonographer’s 
discretion, to demonstrate and track the applicable anatomy/pathology in the peri-CET area. 
 
Sonographer will also measure the thickness of the CET tendon in each applicable image. 
 
Sonographer will scan the contralateral CET tendon in the same manner noting the change 
in the tendon (Right v. Left) and (Treated v. Untreated). 
  
Common Extensor Tendon 
Figure 4: representative long axis ultrasound images 
 
Outcome measures 
Subjects  will complete subject reported outcome measures at 0, 2, 4, 8, 12, and 24 weeks 
and will undergo a focused physical examination and diagnostic ultrasound at 0, 2, 4, and 8  
weeks. Adverse events will be recorded at each visit.  Treatment tolerability will be assessed 
immediately after each treatment using the Visual Analog Scale for Pain (VAS) or Universal 
Pain Assessment Tool (Appendix 3-B). The VAS will be used for 2 different assessments: 1. 
Pain related to physical activity of the symptomatic arm before treatments and at follow-up 
visits and phone surveys. 2. Pain tolerance of the therapy treatment. Each of these 
assessments will be documented and evaluated separately.   
 
 
Aim 1: reported outcomes 
The principal aim of this study is to assess the efficacy of treatment and time course of 
response to treatment using validated subject reported outcome measures assessing pain, 
function and level of activity. Subjects will complete validated subject reported outcome 
questionnaires assessing pain, function and level of activity prior to initiating treatment and at 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
0, 2, 4, 8, 12, and 24 weeks after starting treatment (Appendix 2 and 3A).   
 
Clinical Pain and Treatment Tolerance will be assessed using the Visual Analog Scale for 
Pain (VAS) or Universal Pain Assessment Tool (Appendix 3-B).  
 
Function will be assessed using three validated response forms: PRTEE - An index of the 
severity of CET Tendinopathy18 (Appendix 2), Self-Reported Outcome Measures (SROM)16. 
 
Level of Activity will be assessed using the activity subscale of PRTEE18 (Appendix 2). This 
subscale scores quantitatively the level of difficulty subjects face when they perform basic 
activities of daily living. It has shown to be an accurate and reliable predictor of the activity 
level while performing day-to-day activities.  
 
Statistical analysis 
Data will be assessed for variance homogeneity and normality. PRTEE18, and Visual Analog 
Scale for Pain (VAS) or Universal Pain Assessment Tool (Appendix 3-B) scores will be 
assessed before and after intervention. The VAS will be used for 2 different assessments: 1. 
Pain related to physical activity of the symptomatic arm before and after treatment. 2. Pain 
tolerance of the therapy treatment. Each of these assessments will be documented and 
evaluated separately.   
 
Aim 2: CET Tendon thickness 
Diagnostic ultrasound imaging will be performed with an FDA approved ultrasound scanner 
(Spark® System, Ardent Sound, Inc. – Mesa, AZ, see Appendix 7-B using a coupling gel 
(Polysonic®, or AquaSonic®, Parker Laboratories, Inc., Fairfield, NJ, see Appendix 7-C) by a 
trained sonographer or physician. Subjects will be treated seated with their arm resting on a 
structure that is comfortable for the subject and technologist.   
CET Tendon thickness is measured before treatment(s) and at each documented 
assessment (Appendix 1). Paired t tests are used to compare the CET Tendon thickness 
means between pre- and post-treatment between the symptomatic and treated arm and the 
asymptomatic and untreated arm. P<0.05 is considered to be statistically significant. Any 
peri-CET pathology will also be documented.  
 
Aim 3: Assessment of safety and tolerability 
 
Subject self-assessments of treatment tolerability will be conducted immediately after 
treatments, and at each follow-up visit and phone survey using a 10-point visual analog scale 
VAS, (Appendix 3-B).  The subject will be asked to report their current level of pain and the 
maximum level of pain experienced since the last treatment. The surveyor will remind the 
subject of the VAS criteria and record their reply. The VAS is the standard for assessing pain 
for both clinical and research purposes22.  
 
Recording of adverse events will take place at all visits (see adverse event reporting form 
Appendix 5). Adverse events will be monitored throughout the study. 
 
A treatment will not be administered if there is residual pain/discomfort experienced by the 
subject from the previous treatment.   
 
ACCOUNTABILITY 
Treatment administered to the subjects will be documented by the operator and tracked on 
the Case Report Form (CRF).   

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
BREAKING THE CODE IN AN EMERGENCY 
Treatment codes and allocation of treatment per subject will be accessible by the Principal 
Investigator of the study. 
 
SAFETY MONITORING 
ADVERSE EVENT 
An adverse event (AE) is any untoward medical occurrence in a subject, whether or not 
related to study product or study procedures. Adverse events include any occurrence that is 
new in onset, an exacerbation of a pre-existing condition and clinically significant laboratory 
values.  
 
Exceptions 
The following medical occurrences will not be reported as AEs; 
• 
Pre-treatment Adverse Events; Any medical occurrence that occurs after informed 
consent, but before first administration of ITU treatment or first study procedure is 
considered as medical history and only recorded as an AE if it worsens during the study. 
• 
Pre-existing medical condition; Events that occur with comparable frequency and 
severity to the subject’s baseline condition are reported as medical history, not AEs 
unless they become exacerbated during the study.  
• 
Pregnancy; This is not an AE however the PI must report any pregnancies to The 
Guided Therapy and the Institutional Review Board (IRB) for advice regarding the 
appropriate course of action.  
 
 
Study Specific Expected Adverse Event 
The following AEs are expected due to the use of these study products and/or procedures and 
for this specific study, they will not be regarded as AEs;  
x Transient erythema may be expected as a result of the study treatment which is 
expected to subside after a few hours. This will not be recorded as an AE unless 
persistent after 24 hours. 
x 
Subjects may experience mild-moderate tingling, warming, pain or discomfort during 
the study treatments.  These will not be recorded as AEs unless persistent after 24 
hours or if they increase to severe/unbearable sensations.  
 
The following AEs may be expected due to the use of these study products and/or 
procedures and for this specific study, they will be regarded and recorded as AEs; 
 
x 
While trained personnel will administer the study treatments, there is a possibility for 
operator error that may result in a burn or high skin irritation response. These will be 
recorded as AEs.  

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
SERIOUS ADVERSE EVENT 
A serious adverse event (SAE) is an AE that results in any of the following outcomes: death; a 
life-threatening event; in-patient hospitalization; prolongation of existing hospitalization; a 
persistent or significant disability/incapacity; a congenital anomaly or birth defect. Any other 
important medical event may be considered a SAE when the event may jeopardize the subject 
and may require medical or surgical intervention to prevent one of the outcomes listed 
previously. Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, or convulsions that do not result in in-patient 
hospitalization. Just as a stable pre-existing condition is not an AE, hospitalisation for elective 
treatment (e.g. cosmetic or dental procedure) of a pre-existing condition that did not worsen from 
baseline is not an SAE. 
SEVERITY AND RELATEDNESS OF ADVERSE EVENTS 
An AE will be recorded only once, with the most extreme severity. Severities are defined as: 
Mild 
Awareness of symptoms which require minimal or no treatment and do not 
interfere with daily activity 
Moderate 
Discomfort or low level of interference which is enough to interfere with but not 
prevent daily activity and may require treatment 
Severe 
Interrupted or unable to perform usual daily activity and usually requires 
treatment. 
 
The likelihood that the AE was related to the study product or study procedure is defined as; 
Not Related The AE is clearly due to an alternative cause, even if this cannot be definitely 
identified. Alternative causes include disease, concomitant medications, or 
environmental factors. 
Uncertain 
A connection between the AE and the study product or procedure cannot be 
ruled out with certainty. 
Definitely 
The AE is clearly related to the study product or procedure. 
REPORTING OF ADVERSE EVENTS 
All AEs will be recorded in the CRF and submitted to the IRB at the end of the study 
treatment phase and at the end of the regression phase. The site staff must maintain source 
documents to fully record all AEs.  
Additionally SAEs must be reported immediately to the IRB Title with 24 hours of the site 
staff becoming aware of the event. The contact details for reporting any expedited AE are 
given in the Contacts section of this protocol.  
In the event that the percent of study related AEs is ≥25% for a specific AE symptom, the 
IRB Title should be notified within 24 hours.   
FOLLOW-UP OF ADVERSE EVENTS 
If an AE is ongoing at the end of the study, follow-up will be performed until the AE has 
resolved. Follow-up may take the form of subject visits, a referral to another specialist, site 
telephone calls to the subject or letters from the treating physician.  
The PI or designee must comply with the specific reporting requirement(s) of the ethics 
committee.  
PREGNANCY  
Females may not participate in this study if they are pregnant, breastfeeding, were pregnant or 
gave birth within the last three months or are planning a pregnancy during the course of the 
study.   

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
If the subject thinks they have become pregnant during the study it is important that they inform 
the study doctor immediately. If the subject becomes pregnant or thinks that they may be 
pregnant, they will be removed from the study. 
STATISTICAL CONSIDERATIONS 
SAMPLE SIZE CALCULATION 
Up to 25 subjects will be enrolled onto the study to ensure a minimum of 25 subjects 
complete. 
STATISTICAL METHODS 
A sample size of 25 per protocol subjects will be required to demonstrate statistical 
significance (two-sided alpha=0.05; 80% power). Descriptive statistics will be calculated for 
comparison to the values noted in the existing literature. 
 
MONITORING 
The PI agrees that the site will permit, if required, study-related monitoring, audits, IRB/IEC 
review, and regulatory inspection(s), providing direct access to source data/documents. 
Sponsor personnel, or their designees, may monitor the study. The monitor has the 
responsibility to familiarise the PI and the entire centre staff involved in the study with 
Therapy procedures. The monitor can visit the clinical study centre on a regular basis such 
as before the first subject has been enrolled, during the course of the study, and at study 
completion. The monitor must maintain the confidentiality of the study documents. Regular 
visits may be made to monitor clinical procedures throughout the study duration. 
DATA HANDLING AND RECORD KEEPING 
Measurement and questionnaire data and images will be acquired by or sent to GTS for 
analysis. All clinical data will be collected/recorded by clinical site and reported to the GTS 
within two (2) weeks after the completion of the initial phase of the study (Week 8).  Final, 
QA-approved raw data in SAS or Excel format (where applicable) will be sent to GTS for 
analysis within 2 weeks following completion of each phone survey. 
There will be at least one CRF for each subject randomised into the study. It is the 
responsibility of the PI to ensure the completeness and accuracy of the CRF and to authorise 
only trained members of staff to complete the CRF.  
The CRF must be completed legibly, using a black ballpoint pen. Erroneous values and/or 
text must not be obliterated. Instead, the error must be crossed out with a single line, the 
correct value/text added, and the correction signed or initialled and dated. At the end of the 
study, the original CRFs will be sent to The TBD Title and copies held at the study site.  
All site staff must ensure that the subject's anonymity will be maintained. On all documents 
that are to be submitted to GTS or external laboratory, subjects must be identified only by an 
identification code and not by their names. The PI or designee must keep a separate 
confidential enrollment log that matches identifying codes with the subject's names and 
addresses. The PI or designee must maintain these documents at the site.  
It is the responsibility of the PI or designee to maintain adequate clinical study records. 
Copies of all clinical study material must be archived for a period of at least 15 years after the 
end of the study (or more as legally required) or until informed by GTS that the documents 
can be destroyed. All documents must be archived in a secure place and treated as 
confidential material. 
QUALITY STANDARDS 
It is the responsibility of the PI to ensure that the study is conducted in accordance with the 
principles of Good Clinical Practice, the 2008 version of the Declaration of Helsinki and 
according to applicable local laws and regulations concerning studies conducted on human 
subjects which are outside of the definition of a medicinal product or medical device. 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
Quality assurance audits may be performed by the clinical site, GTS or any ethics committee 
or regulatory authority during the course of the study or at study completion. 
The clinical trial will be conducted in accordance with the approved protocol and protocol 
amendments (if applicable). However, in the unlikely event of a major protocol deviation (i.e., 
those deviations which affect the integrity of the study or the safety of subjects) a protocol 
deviation form will be completed by the Principal Investigator (or designee) and submitted to 
the GTS and IRB for review and approval. The GTS will review the deviations and determine 
if the deviation(s) would significantly affect the results, and if deemed necessary, not include 
such data in the analysis.  All other minor deviations should be recorded throughout the 
study and submitted to the GTS Title on a monthly basis.  
ETHICS AND INFORMED CONSENT 
The PI or designee must submit a copy of the protocol, informed consent form and all 
supporting documents to an Independent Ethics Committee or Institutional Review Board 
who must provide written approval before study specific procedures commence. The IEC/IRB 
must also approve any other information that is given to subjects such as advertisements 
and may require other documents such as study product documentation.   
Any modification to the agreed protocol must be agreed by both GTS and the PI and 
approved in writing by the IEC/IRB. Written approval must be obtained from the IEC/IRB 
before any amendment is implemented, unless immediate change is required to eliminate 
hazards to the subjects or when the change(s) involves only logistical or administrative 
aspects of the study (e.g., change of monitor(s), telephone number(s)).   
The PI or designee must obtain informed consent from each subject participating in the 
study, after explanation of the aims, methods, benefits and potential hazards of the study. 
The consent must be obtained before any study-specific procedures are performed. It must 
be made completely and unambiguously clear to each subject that they are free to refuse to 
participate in the study, or that they can withdraw their consent at any time and for any 
reason, without incurring any penalty or withholding of treatment. The subject must be given 
their own copy of the information sheet and signed consent form. The original signed 
informed consent must be kept on file by the PI or designee. 
REPORTING AND PUBLICATION POLICY 
Statistical analysis will be performed by GTS.   
 
The Investigator or designee will issue a final report of the results of the study following 
completion of data collection and quality control. The report will include the following: 
tabulations, a summary of adverse events, a description of the study, the study number, 
dates the study was conducted, the number of subjects who participated in the study as well 
as demographics (age, gender, ethnicity) and a summary of deviations. All IRB 
documentation/approvals must be included in the report. A complete report (electronic is 
acceptable) will be provided to the Sponsor within four weeks after completion of the 12 
week follow-up. A final report will be submitted with four weeks of the 24 week follow-up 
phone call.  
 
 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
REFERENCES 
 
1. Hong QN, Durand MJ, Loisel P. Treatment of lateral epicondylitis: where is the evidence? Joint Bone 
Spine 2004; 71(5):369–373.  
2. Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal 
disorders of the upper limb in the general population. Arthritis Rheum 2004; 51(4):642–651.  
3. 3 Ollivere CO, Nirschl RP. Tennis elbow:current concepts and rehabilitation. Sports Med 1996; 
22(2):133–139.  
4. 4 Regan W, Wold LE, Conrad R, Morrey BF. Microscopic histopathology of chronic refractory lateral 
epicondylitis. Am J Sports Med 1992; 20:746.  
5. 5 Kraushaar BS, Nirschl RP. Tendonosis of the elbow (Tennis Elbow). Clinical features and finding of 
histological, immunohistochemical, and electron microscopy studies. J Bone Joint Surg Am 1999; 
81:259–278. 
6. Lateral Elbow Tendinopathy: Correlation of Ultrasound Findings With Pain and Functional Disability Am J 
Sports Med June 2010 38 1209-1214; published online before print March 24, 2010, 
 
7. Maffulli N, Khan K M, Puddu G. Overuse tendon conditions. Time to change a confusing terminology. 
Arthroscopy 1998. 14840–843.843. [PubMed] 
8. Archambault J M, Wiley J P, Bray R C. Exercise loading of tendons and the development of overuse 
injuries. A review of the current literature. Sports Med 1995. 2077–89.89. [PubMed] 
9. Sharma P1,Maffulli N. Biology of tendon injury: healing, modeling and remodeling. J Musculoskelet 
Neuronal Interact. 2006  
10. Ustuner E, Toprak U, Baskan B, Oztuna D. Sonographic examination of the common extensor tendon of 
the forearm at three different locations in the normal asymptomatic population; Surg Radiol Anat (2013) 
35:547–552 DOI 10.1007/s00276-013-1084-6 
11. Apr-Jun;6(2):181-90.Gliklich R, White WM, Barthe PG, Slayton MH, Makin IRS. Clinical pilot study of 
intense ultrasound (IUS) therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast 
Surg 2007; 9:88-95.  
12.  Suh DH, Shin MK, Lee SJ, et al. Intense focused ultrasound tightening in Asian skin: Clinical and 
pathologic results. Dermatol Surg. 2011;37: 1595-1602  
13.  Alam, M., L. E. White, et al. (2010). "Ultrasound tightening of facial and neck skin: a rater- blinded 
prospective cohort study." J Am Acad Dermatol 62(2): 262-269.  
14. White, W. M., I. R. Makin, et al. (2007). "Selective creation of thermal injury zones in the superficial 
musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial 
rejuvenation." Arch Facial Plast Surg 9(1): 22-29. 
15. Slayton M., Barton J, Feasibility of Modulating Healing Tissue Response by ITU (Intense Therapy 
Ultrasound) in Musculoskeletal Tissue ASLMS, 2014, IEEE, 2014 
16. Rose, M., et al., Evaluation of a preliminary physical function item bank supported the expected 
advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin 
Epidemiol, 2008. 61(1): p. 17-33. 
17. Hawker, G.A., et al., Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating 
Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire 
(SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and 
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken), 2011. 
63 Suppl 11: p. S240-52 
18. Rompe JD1, Overend TJ, MacDermid JC.  Validation of the Patient-rated Tennis Elbow Evaluation 
Questionnaire.J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. 
 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
Appendix 1- Calendar of Events 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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        Protocol V11 May 1, 2015 
 
Appendix 2 – PRTEE (attachment) 
 
 
 

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        Protocol V11 May 1, 2015 
 
Appendix 2 – PRTEE (attachment), continued 
 
 
 
 
 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
Appendix 3-A; Self Reported Outcome Measures 
 

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        Protocol V11 May 1, 2015 
 
Appendix 3-B – Subject Self-Assessment Questionnaire, continued: 
 
VAS: Visual Analog Scale for Pain or Universal Pain Assessment Tool. 
 
 
 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
APPENDIX 4 – Clinical Site Physical Therapy 
 
TBD along with clinical site and PI 
 
 
 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
Page 28 of 35 
        Protocol V11 May 1, 2015 
 
Appendix 5: Adverse Events Report 
 Sample AE Form 
 
 
AE Term 
Serious  
Yes/ No 
Severity, 
Relationship, 
Action 
Taken 
Treatment of 
Event (if 
medication 
report  CM) 
 
Outcome 
1 
 
 
Severity: 
 
 
 
Relationship: 
  
 
 
Action 
taken: 
 
 
 
o 
01 
o 
02 
o 
03 
o 
04 
o 
05 
(specify) 
 
 
 
 
Onset 
date: 
 
 
 
 
 
End date:  
 
 
 
 
 
 
 
2 
 
 
Severity: 
 
 
 
Relationship: 
  
 
 
Action 
taken: 
 
 
 
o 
01 
o 
02 
o 
03 
o 
04 
o 
05 
(specify) 
 
 
 
 
Onset 
date: 
 
 
 
 
 
End date:  
 
 
 
 
 
 
 
 
Severity 
Relationship 
Action Taken 
Treatment of Event: 
Outcome:  
Mild  
 
Moderate 
 
Severe 
01= Not 
Related to 
treatment 
02=Probably 
related to 
treatment 
03=Definitely 
related to 
treatment 
 
01=None 
 
02=Treatment 
interrupted 
 
03=Treatment 
stopped 
01=None 
02=Pharmacological 
Treatment (report 
CM) 
03=Non-
Pharmacological 
Treatment 
04=Hospitalization 
05=Other 
01=Recovered 
02=Recovered 
w/ Sequelae 
03=Recovering 
04=Not 
Recovered 
05=Fatal 
06=Unknown 
 
 
Investigator Signature: __________________                        Date:______/________/_______ 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
Appendix 6-A: Home Treatment example. (PI may suggest other exercise protocols) 
 
Subjects will apply ice or cold pack to the affected area for (times and duration to be 
confirmed with Clinical Site/PI) 
 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
Page 30 of 35 
        Protocol V11 May 1, 2015 
 
Appendix 6-B: Home Treatment Log  
 
 
Strenthening 
(Exercise 3 & 4)
Strenthening 
(Exercise 5 & 6)
Massage 
(Exercise 7)
Set 1
Set 2
Set 3
Set 4
Set 5
Set 1
Set 1
Set 1
1/12/2015
1/13/2015
1/14/2015
1/15/2015
1/16/2015
1/17/2015
1/18/2015
1/19/2015
1/20/2015
1/21/2015
1/22/2015
1/23/2015
1/24/2015
1/25/2015
1/26/2015
1/27/2015
1/28/2015
1/29/2015
1/30/2015
1/31/2015
2/1/2015
2/2/2015
2/3/2015
2/4/2015
2/5/2015
2/6/2015
2/7/2015
2/8/2015
2/9/2015
2/10/2015
2/11/2015
2/12/2015
2/13/2015
2/14/2015
2/15/2015
2/16/2015
2/17/2015
2/18/2015
2/19/2015
2/20/2015
2/21/2015
2/22/2015
2/23/2015
2/24/2015
2/25/2015
2/26/2015
2/27/2015
2/28/2015
3/1/2015
3/2/2015
3/3/2015
3/4/2015
3/5/2015
3/6/2015
3/7/2015
3/8/2015
3/9/2015
3/10/2015
3/11/2015
3/12/2015
3/13/2015
3/14/2015
3/15/2015
3/16/2015
Sets per Day
CET Stretch (exercise 1 & 2)

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
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        Protocol V11 May 1, 2015 
 
 
Appendix 7 – Marketed Materials Information 
 
Appendix 7-A – ITU Systems  
 
 
 
 
 
Clinical Prototype Systems Gen II and Gen III 
 
 
Power:   
3-100 Watts 
 
 
 
Frequency: 
3 – 10MHz 
 
Energy/Zone:  up to 3 Joules (tech. mode) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 7-B – Diagnostic Ultrasound Imaging System  
 

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        Protocol V11 May 1, 2015 
 
Appendix 7-B – Diagnostic Ultrasound Imaging System, continued 
 
 
 
 
 
 
 
 
 
 
 
 

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        Protocol V11 May 1, 2015 
 
Appendix 7-C – Acoustic Coupling Gel – Polysonic or similar 
 
POLYSONIC® Ultrasound Lotion 
 

GUIDED THERAPY SYSTEMS, CONFIDENTIAL 
Page 35 of 35 
        Protocol V11 May 1, 2015 
 
Appendix 7-C – Acoustic Coupling Gel, continued