Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis Musculoskeletal Pain Reduction
Phase: NA
Conditions: Plantar Fasciitis, Chronic
Sponsor: University Foot and Ankle Foundation

 
 
 
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TITLE: Preliminary Protocol for Intense Therapeutic Ultrasound for the Treatment         
of Chronic Plantar Fasciitis 
 
PROTOCOL NO.:  WIRB® Protocol #20160753  
 
         DATE: April 27, 2016 
 
SPONSOR:  Guided Therapy Systems  
 
           33 S. Sycamore 
 
           Mesa, Arizona  85202-1150  USA 
 
INVESTIGATOR:  Bob Baravarian, DPM  
      
 
 
2121 Wilshire Blvd, Suite 101  
      
 
 
Santa Monica, CA 90403 United States  
310-828-0011 
 
 
 
310-435-9279 (24-hours) 
Background 
Chronic Plantar fasciitis (CPF) is a common cause of plantar heel pain that is a result of a degenerative 
process of the plantar fascia and its surrounding perifascial structures [1].  It is the most common cause of heel 
pain, affecting 10% of the U.S. population, and one of the most common foot and ankle problems [2]. One 
study showed that individuals with this disease scored significantly lower in general health-related quality of life 
in addition to foot specific quality of life (pain and function) [3]. In addition to a decreased quality of life, 
significant financial costs arise for these individuals: it is estimated that annual cost of treating this disease in 
the United States is 192-376 million dollars [4].   
The plantar fascia, or plantar aponeurosis, originates on the posterior tuberosity of the calcaneus and inserts 
into the proximal phalanges of the toes. It acts like a cable, which tightens with flexion of the 
metatarsophalangeal joints, the “windlass” mechanism, thereby restoring the arch during mid-stance, stiffening 
the medial column of foot for pushoff and transferring the force of the gastrocnemius muscle contracture to the 
ground [5]. Although the exact etiology of CPF is unclear, the predominance of evidence indicates that it is the 
combination of age and overuse which lead to degenerative changes within the fascia that result in the 
symptoms associated with this disease [1].The most common presentation for patients with plantar fasciitis 
include pain with the first few steps in the morning, pain at the beginning of the activity that resolves with 
continued activity, pain and stiffness with prolonged standing, and pain at the end of the day [6]. 
The diagnosis of CPF is made clinically based on history and physical exam [6].  Confirmation with diagnostic 
imaging may be necessary when the symptoms are atypical or are refractory to treatment.  MRI is a useful 
diagnostic tool to evaluate for plantar fascia thickening and edema in and around the fascia, both of which are 
consistent with the diagnosis of CPF. In addition, many physicians use MRI to exclude other causes of plantar 
heel pain [7]. Ultrasound can also be used to quantify the thickness of the plantar fascia. Multiple studies have 
shown that patients with CPF have increased thickness of the fascia compared to asymptomatic individuals [8-
12]. Mean thickness in these studies for subjects with CPF range from 4.8-6.5 mm as opposed to 2.3-4.0 mm 
for subjects without the disease [8-13]. One of the studies showed that the thickness was increased in medial, 
central and lateral bands of plantar fascia uniformly along with 68% of patients with CPF reporting central band 
tenderness as opposed to 26% having lateral band tenderness [12]. In addition to the evidence of inflammation 
[9], the presence of a hyperechoic lesion in the plantar fascia was noted in 68% [10]  to 84% [8] of patients with 

 
 
 
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CPF. Diagnostic ultrasound has also been used to quantify the effectiveness of treatments such as extra-
corporeal shock wave therapy, NSAIDs and Botox injections for subjects with CPF [11, 13]. 
More than twenty different treatments have been used for plantar fasciitis [14]. The combination of rest, ice, 
stretching and NSAIDs are used as initial management in most patients and have been shown to effectively 
treat symptoms in 90% of patients in less than 12 months [6]. However, 10% of patients fail conservative 
management and continue to have symptoms beyond 12 months (termed refractory plantar fasciitis or RPF) [1, 
15, 16]. Surgery consisting of partial plantar fascia release or gastrocnemius recession is often considered in 
these patients.  However, the outcomes of surgery are not uniformly positive with 50% of patients having 
residual symptoms. Moreover, evidence supporting surgical treatment of RPF is weak as there are no 
randomized controlled trials comparing its efficacy to other treatments.  Thus, for many patients the risks of 
surgery such as arch instability, prolonged wound healing, and longer rehabilitation times simply outweigh the 
benefits [1]. ITU may be a non-invasive treatment that can be used as an adjunct to speed healing in patients 
with CPF and as an alternative to surgery in those with RPF. 
Intense Therapeutic Ultrasound (ITU) 
Various types of ultrasound have been used to treat soft tissue injuries since the 1930s [17]. Intense 
therapeutic ultrasound (ITU) is a recently developed ultrasound based therapy in which sound waves are 
concentrated to produce selective thermal coagulative change over a small area while leaving the remaining 
regions unaffected [18].  ITU has been used clinically for treating the facial skin for the past decade and it has 
recently received FDA approvals for non-surgical brow and submental tissue lifting. Over 1,000,000 patients 
worldwide have been treated using this technology. Clinical studies have shown that 85% of subjects receiving 
this treatment on facial skin tissue showed an improvement in facial lifting with no significant pain, erythema, 
inflammation or scarring [19, 20]. Histologically, it has been shown that ITU induces the production of dermal 
collagen with thickening of the dermis and straightening of the elastic fibers in the reticular dermis [18]. On-
going research in our laboratory has shown that ITU can improve healing of damaged Achilles tendon in a 
rabbit model [21]. Preliminary results showed an increase in markers for wound healing (e.g. VEGFa, TNFα, 
IL-1β, and TGFβ1) and a decrease in markers for scar tissue formation (e.g. COL1a1, COL1a2, and 
COL2a1) in injured rabbit tendon treated with ITU compared to injured, untreated rabbit tendon.  These results 
have led us to want to explore the possibility using ITU to treat patients with CPF. 
Sept 2014 – present, ITU treatment for Plantar Fasciosis is currently being studied at the University of Arizona 
(University of Arizona - IRB approval #: 1404296558). To date we have completed 28 subjects with no adverse 
effects noted. Preliminary results were published August, 2015[27]. 
 
Purpose of Study 
The purpose of this study is to assess the effectiveness of ITU in the treatment of CPF by assessing pain, 
function, and change in perifascial lesions treated with ITU in addition to standard of care. The primary 
outcome measures will be clinical grading for plantar fasciitis/osis grading and subject reported questionnaires 
where pain, function and level of activity will be compared before, during and at 24 weeks after the first of 2 
treatments. In addition diagnostic ultrasound images will assess the change of any perifascial hypoechoic 
lesions. Finally, the safety and tolerability of ITU will be monitored through the course of the study.  It is 
hypothesized that patients receiving ITU in addition to standard of care will have a more rapid resolution of 
their pain, faster return to activities, and a decrease in perifascial lesions.  
Materials and Methods 
The primary objective of this study is to evaluate the efficacy of combining intense therapeutic ultrasound 
(ITU) with standard care, including post-treatment therapy, exercises and boot immobilization for the treatment 

 
 
 
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of chronic plantar fasciitis/osis. A secondary objective is to evaluate the tolerability and safety of intense 
therapeutic ultrasound in the treatment of plantar fasciitis. 
These objectives will be accomplished through the following specific aims: 
Aim # 1: Compare subject reported outcomes of pain, function and level of activity for all subjects before and 
after treatment. Follow the subjects for 24 weeks by clinic visits and phone surveys.  
Aim # 2: Compare the changes in perifascial lesion volume for all subjects before and after treatment by 
diagnostic ultrasound imaging. Follow the subjects for 12 weeks by clinic visits. 
Aim # 3: Evaluate the tolerability and safety of ITU for the treatment of the chronic plantar fasciitis. 
Selection of Subjects 
The study population will consist of up to 30 subjects recruited from the associated UCLA outpatient clinics. 
The selection of suitable subjects will be made according to the inclusion and exclusion criteria described 
below.  
Inclusion Criteria 
Male and female adults (18 to 70 years) with plantar heel pain and point tenderness near the medial calcaneal 
insertion of the plantar fascia for at least three months without improvement will be considered for inclusion into 
the study. 
Subjects must be willing and able to follow post treatment regimen including immobilization boot for 2 - 4  
weeks after each treatment, and massage therapy.  
Exclusion Criteria 
Subjects with diabetes or other circulatory issues that might impede healing, bilateral plantar heel pain, current 
systemic or local infection (within the last 30 days), previous foot surgeries, other previously diagnosed 
foot/ankle pathologies (inflammatory arthritis, gout, neurologic disorders, connective tissue disorders, bone 
spurs and fragments and malignancy), unwilling or unable to complete post regimen, and pregnancy will be 
excluded. Also excluded are subjects with thick calluses on their heel, making ultrasound imaging and 
treatment of the plantar fascia difficult. 
Interventions 
Standard of care treatment will include massage 5 minutes daily as defined by PI and the use of an 
immobilization boot along with an orthotic insert for 2 to 4 weeks after the each treatment. The decision to 
continue or discontinue the boot will be made during the follow-up phone call 2 weeks after each treatment. 
The caller will discuss (Appendix 1-F) the subject’s progress and come to a decision on continuing or stopping 
the use of the boot. When it is determined that a subject can stop using the boot, they will continue to use the 
orthotic insert in firm soled shoe that does not flex or bend – Tennis shoe, platform, wedge, Birkenstock or 
FitFlopTM sandal. At that point the subject can resume light activities: Walking on a flat, hard surface (no hiking 
trails), bicycling and light exercises. Subject will massage region twice a day for 2 ½ minutes per each time, 
total 5 minutes/day.   
 
During Visit 2 (4 weeks after the first treatment), subjects will receive a second treatment if heel pain is not 90% 
resolved. The use of the boot and orthotic will resume as defined after the first treatment. If a week 4 visit is not 
possible we will allow a 2nd treatment at week 6, if such treatment is deemed necessary. If a 2nd treatment is 
moved to week 6, subsequent follow-up dates will be adjusted accordingly.  ITU treatments will be performed 
using a GEN III system (Guided Therapy Systems, Mesa, AZ, Appendix 4). Trained study personnel will conduct 
the treatments.  The treatment session will last 15 – 20 minutes. During this time the subjects will be required to 
lay prone on an exam table with their feet hanging over the end of the table. An average energy up to 5 joules / 
thermal zone will be administered to the plantar fascia in a linear pattern (Figure 1) with up to 360 thermal zones. 
Each thermal zone will be less than 1 mm3 in volume, centred at 10 - 15 mm depth, and approximately 1-3 mm 
apart.  

 
 
 
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Treatment pattern transverse across the Plantar Fascia: 
 
Figure 2. Treatment Zones 
Outcome measures 
Subjects will complete subject reported outcome instruments, and will undergo a focused physical examination 
and diagnostic ultrasound at 0, 4, 8, 12 weeks. At 2, and 24 weeks a phone survey will be administered by the 
Clinical Coordinator using the same subject report outcome questionnaires. Adverse events, if any, and 
treatment tolerability will be recorded at each visit and 2-3 days after each treatment.   
Aim 1: Subject reported outcomes and structured physical exam 
The principal aim of this study is to demonstrate the efficacy of treatment and time course of response to 
treatment and post treatment regimens using validated subject reported outcome measures assessing pain, 
function and level of activity and structured physical examination. Subjects will complete validated subject 
reported outcome questionnaires assessing pain, function and level of activity prior to initiating treatment and 
at 4, 8, 12, and 24 ( 24 week surveys will be completed by a phone interview) weeks after starting treatment.  
Subjects will also be contacted 2-3 days following each treatment to assess treatment tolerability and to 
document and address adverse effects (if any). They will also be contacted by phone 2 weeks after 
Figure 1: The treatment site located 
around the insertion of the plantar fascia 
onto the posterior process of the calcaneus 

 
 
 
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treatment(s) to assess progress and determine if the boot can be discontinued.  
 
Pain will be assessed using the of the foot function index pain subscale (FFI-P) and the subject reported 
outcome measures (SROM).  These two instruments have been used to assess pain in previous studies of 
plantar fascia treatments. [22, 23] 
 
Function will be assessed using two validated PRO instruments the PROMIS PF CAT and the FAAM. The 
PROMIS PFCAT is a subject relevant outcome measure that uses computer adaptive survey questions to 
assess the subject’s pain and function in relation to daily activities [24].  The FAAM has been shown to be a 
reliable, responsive, and valid measure of physical function for individuals with a broad range of 
musculoskeletal disorders of the lower leg, foot, and ankle [25].  
 
Level of Activity will be assessed using the activity subscale of FAAM. 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 [25]  
 
Structured physical examination will consist of assessment of hindfoot and midfoot alignment, inspection for 
swelling, palpation of the calcaneus and entire plantar fascia, range of motion of the ankle with the knee flexed 
and with the knee extended, and calcaneal squeeze test. Pertinent positive findings on exam include: valgus 
hindfoot, midfoot planus, tenderness to palpation at the insertion of the plantar fascia onto the calcaneus, ankle 
dorsiflexion less than 10 degrees with the knee extended or greater than 10 degree augmentation in ankle 
dorsiflxion with the knee flexed. Pertinent negative findings include: lack of swelling at the ankle and midfoot, 
no tenderness at the Achilles insertion, the retrocalcaneal bursae, along the arch, posterior to the medial 
malleolus, or at Baxters point, and positive calcaneal squeeze test. 
 
Statistical analysis 
Data will be assessed for variance homogeneity and normality. FFI-P scores, PFCAT, FAAM scores before and 
after intervention will be compared using a paired t-test. Perifascial lesion volume is measured before and at 
each post treatment clinical visit using diagnostic ultrasound imaging, and paired t-tests will be utilized for 
comparison. For determination of statistical significance, a cutoff value of α=0.05 has been selected prior to 
start of data analysis. 
 
Aim 2: Assessment of Perifascial Hypoechoic Lesions 
Diagnostic ultrasound imaging will be performed with an FDA 510(k) cleared ultrasound scanner (Spark® 
System, Ardent Sound, Inc. – Mesa, AZ, see Appendix 5) using a coupling gel (Polysonic®, Parker Laboratories, 
Inc., Fairfield, NJ, see Appendix 6) by a trained sonographer or physician. The subject will positioned prone on 
an exam table with the feet over the edge of the table. The plantar fascia of the affected and contralateral feet 
will be imaged. The thickness and depth of the fascia as well as the size and location of any hypoechoic 
lesion(s), when present, will be recorded using both long and short axis imaging. Change in the volume of 
hypoechoic plantar fascial lesions relative to the baseline measurement will be calculated.  
 
 
 
 
 
 
                                          Plantar Fascia 
 
                                                                                                Calcaneus 
 
 
 
 
Fat Pad 
Skin Line 
Calcaneus 
Plantar Fascia 
Skin Line 
Hypoechoic Lesion 

 
 
 
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Figure 4: representative long and short axis ultrasound images 
 
Aim 3: Assessment of safety and tolerability 
 
Subject self-assessments of treatment tolerability will be conducted immediately after, two –three days after 
(phone survey) and two weeks after (phone survey) treatment using a10-point visual analog scale (VAS, see 
Appendix 1).  The subject will be asked to report their current level of pain and the maximum level of pain 
experienced over the last few days. The VAS is the standard for assessing pain for both clinical and research 
purposes [26]. All phone surveys will be completed by the Clinical Coordinator. Any adverse effects will be 
noted and addressed during these phone calls.  
 
Recording of adverse events will take place at all clinic visits and follow-up phone calls (see adverse event 
reporting form Appendix 3). Adverse events and serious adverse events will be monitored throughout the study.  
 
 
 
Calcaneus 
Plantar Fascia 

 
 
 
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Timeline 
` 
 
 
 
Visit 0
Visit 1
Visit 1 
Follow-up 
Phone 
Interview 
Treatment 
Tolerability
Treatment 1 
Follow-up 
Phone Call: 
Boot 
Decision
Visit 2
Visit 2 Follow-
up Phone 
Interview 
Treatment 
Tolerability
Treatment 2 
Follow-up 
Phone Call: 
Boot 
Decision
Visit 3
Visit 4
 Phone 
Interview 
Subject's 
Progress 
Survey 2
Baseline      
-14 - 0 Days
Week 0
Week 0       
(+ 2 or 3 
days)
Week 2
Week 4
Week 4        
(+ 2 or 3 days)
Week 6
Week 8
Week 12
Week 24
IC, eligibility 
paperwork, exam 
for inclusion 
criteria
X
PI/Clinical 
Coordinator         
(CC)
Ultrasound Imaging
X
X
X
X
GTS  or PI
ITU Treatment
X
X            
(If 
required)   
GTS  or PI
TBD Clinical grading 
for Plantar Fasciitis 
severity
X
X
X
X
X
PI                    
(cc documentation)
Subject Survey –  
Pain Scale  and 
Ankle Mobility 
Scale
X
X
X
X
X           
Phone 
Interview
Subject              
(cc documentation)
Boot and 
Instructions
X
X
X              
If 2nd 
Treatment is 
Performed
PI                    
(cc documentation)
Shoe, Insert and 
Instructions
X
X
X              
If 2nd 
Treatment is 
Performed
PI/CC
Follow-up call 
Treatment 
Tolerability
X
X              
If 2nd 
Treament is 
Performed
PI/CC
Telephone 
Interview & 
Determine if Boot 
is continued (Week 
2 and 6 only)
X
X              
If 2nd 
Treatment is 
Performed
PI/CC
Procedures
Responsibility

 
 
 
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References 
 
1. 
Neufeld, S.K. and R. Cerrato, Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg, 
2008. 16(6): p. 338-46. 
2. 
Atkins, D., et al., A systematic review of treatments for the painful heel. Rheumatology (Oxford), 1999. 
38(10): p. 968-73. 
3. 
Irving, D.B., et al., Impact of chronic plantar heel pain on health-related quality of life. J Am Podiatr 
Med Assoc, 2008. 98(4): p. 283-9. 
4. 
Tong, K.B. and J. Furia, Economic burden of plantar fasciitis treatment in the United States. Am J 
Orthop (Belle Mead NJ), 2010. 39(5): p. 227-31. 
5. 
Hicks, J.H., The mechanics of the foot. II. The plantar aponeurosis and the arch. J Anat, 1954. 88(1): p. 
25-30. 
6. 
Davis PF, Severud E, Baxter DE. Painful heel syndrome: results of nonoperative treatment. Foot Ankle 
Int. 1994;15(10):531-5. PubMed PMID: 7834059. 
7. 
Berkowitz, J.F., R. Kier, and S. Rudicel, Plantar fasciitis: MR imaging. Radiology, 1991. 179(3): p. 
665-7. 
8. 
Cardinal, E., et al., Plantar fasciitis: sonographic evaluation. Radiology, 1996. 201(1): p. 257-9. 
9. 
Wall, J.R., M.A. Harkness, and A. Crawford, Ultrasound diagnosis of plantar fasciitis. Foot Ankle, 
1993. 14(8): p. 465-70. 
10. 
Tsai, W.C., et al., Ultrasound evaluation of plantar fasciitis. Scand J Rheumatol, 2000. 29(4): p. 255-9. 
11. 
Kane, D., et al., The role of ultrasonography in the diagnosis and management of idiopathic plantar 
fasciitis. Rheumatology (Oxford), 2001. 40(9): p. 1002-8. 
12. 
Vohra, P.K., et al., Ultrasonographic evaluation of plantar fascia bands. A retrospective study of 211 
symptomatic feet. J Am Podiatr Med Assoc, 2002. 92(8): p. 444-9. 
13. 
Mahowald, S., B.S. Legge, and J.F. Grady, The correlation between plantar fascia thickness and 
symptoms of plantar fasciitis. J Am Podiatr Med Assoc, 2011. 101(5): p. 385-9. 
14. 
Thomson, C.E., F. Crawford, and G.D. Murray, The effectiveness of extra corporeal shock wave therapy 
for plantar heel pain: a systematic review and meta-analysis. BMC Musculoskelet Disord, 2005. 6: p. 
19. 
15. 
Boyle, R.A. and G.L. Slater, Endoscopic plantar fascia release: a case series. Foot Ankle Int, 2003. 
24(2): p. 176-9. 
16. 
Davis, P.F., E. Severud, and D.E. Baxter, Painful heel syndrome: results of nonoperative treatment. Foot 
Ankle Int, 1994. 15(10): p. 531-5. 
17. 
Miller, D.L., et al., Overview of therapeutic ultrasound applications and safety considerations. J 
Ultrasound Med, 2012. 31(4): p. 623-34. 
18. 
Gliklich, R.E., et al., Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and 
subcutaneous tissues. Arch Facial Plast Surg, 2007. 9(2): p. 88-95. 
19. 
Suh, D.H., et al., Intense focused ultrasound tightening in Asian skin: clinical and pathologic results. 
Dermatol Surg, 2011. 37(11): p. 1595-602. 
20. 
Schmidt, W.A., et al., Standard reference values for musculoskeletal ultrasonography. Ann Rheum Dis, 
2004. 63(8): p. 988-94. 
21. 
Slayton M., Barton J, Feasibility of Modulating Healing Tissue Response by ITU (Intense Therapy 
Ultrasound) in Musculoskeletal Tissue ASLMS, 2014 
22. 
Pfeffer, G., et al., Comparison of custom and prefabricated orthoses in the initial treatment of proximal 
plantar fasciitis. Foot Ankle Int, 1999. 20(4): p. 214-21. 
23. 
DiGiovanni, B.F., et al., Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients 
with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am, 2003. 85-A(7): p. 1270-
7. 

 
 
 
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24. 
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. 
25. 
Martin, R.L., et al., Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle 
Int, 2005. 26(11): p. 968-83. 
26. 
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. 
27.  
Michael H. Slayton, Ph.D., Richard C. Amodei, RDMS, Ashley McNelly and  L. Daniel Latt MD, Ph.D.; Intense 
Therapy Ultrasound (ITU) for the treatment of Chronic Plantar Fasciitis: Preliminary Results of Clinical Study; 
37th International Conference of the IEEE Engineering in Medicine and Biology; Milan, Italy, August 2015 

 
 
 
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Appendix 1: Patient reported outcome measures 
Appendix 1-A: PROMIS LE CAT 
PFA1_IADL    
Does your health now limit you in doing vigorous activities, such as running, lifting heavy objects, participating 
in strenuous sports?  _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFA10_Lower 
Are you able to stand for one hour?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
Are you able to do chores such as vacuuming or yard work?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA12_Lower 
Are you able to push open a heavy door?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA13_IADL 
Are you able to exercise for an hour?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA14_Lower 
Are you able to carry a heavy object (over 10 pounds)?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA15_Lower 
Are you able to stand up from an armless straight chair?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA19_Lower 
Are you able to run or jog for two miles?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA21_Lower 
Are you able to go up and down stairs at a normal pace?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
Are you able to go for a walk of at least 15 minutes?     _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 

 
 
 
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Appendix  1-A: PROMIS LE CAT, Continued 
PFA25_IADL 
Are you able to do yard work like raking leaves, weeding, or pushing a lawn mower?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA29_Central 
Are you able to pull heavy objects (10 pounds) towards yourself?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA3_Central 
Does your health now limit you in bending, kneeling, or stooping?    _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFA30_Lower 
Are you able to step up and down curbs?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA31_Lower 
Are you able to get up off the floor from lying on your back without help?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA32_Lower 
Are you able to stand with your knees straight?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
Are you able to exercise hard for half an hour?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA37_Central 
Are you able to stand for short periods of time?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA39_Lower 
Are you able to run at a fast pace for two miles?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA4_IADL 
Does your health now limit you in doing heavy work around the house like scrubbing floors, or lifting or 
moving heavy furniture?   _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
 

 
 
 
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Appendix 1-A: PROMIS LE CAT, Continued 
PFA41_Lower 
Are you able to squat and get up?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA42_Lower 
Are you able to carry a laundry basket up a flight of stairs?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA45_IADL 
Are you able to get out of bed into a chair?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
Are you able to bend or twist your back?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA5_IADL 
Does your health now limit you in lifting or carrying groceries?   _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFA51_IADL 
Are you able to sit on the edge of a bed?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA53_IADL 
Are you able to run errands and shop?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA56_IADL 
Are you able to get in and out of a car?    _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFA6_IADL 
Does your health now limit you in bathing or dressing yourself? 
 _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFA7_Lower 
How much do physical health problems now limit your usual physical activities (such as walking or climbing 
stairs)?    _______ 
5 = Not at all 4 = Very little 3 = Somewhat 2 = Quit a lot 1 = Cannot do 
 
Are you able to move a chair from one room to another?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 

 
 
 
Page | 13 
Unable to do 
Appendix 1-A: PROMIS LE CAT, Continued 
PFA9_Lower 
Are you able to bend down and pick up clothing from the floor?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB1_IADL 
Does your health now limit you in doing moderate work around the house like vacuuming, sweeping floors or 
carrying in groceries?   _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFB10_Lower 
Are you able to climb up five steps?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB11_IADL 
Are you able to wash dishes, pots, and utensils by hand while standing at a sink?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB12_IADL 
Are you able to make a bed, including spreading and tucking in bed sheets?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB13_IADL 
Are you able to carry a shopping bag or briefcase?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
Are you able to take a tub bath?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB24_Lower 
Are you able to run a short distance, such as to catch a bus?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB3_IADL 
Does your health now limit you in putting a trash bag outside?   _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFB32_Lower 
Are you able to stand unsupported for 10 minutes?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 

 
 
 
Page | 14 
Appendix 1-A: PROMIS LE CAT, Continued 
 
PFB40_Lower 
Appendix 1-A: PROMIS LE CAT, Continued 
 
Are you able to stand up on tiptoes?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB42_Lower 
Are you able to stand unsupported for 30 minutes?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB43_IADL   _______ 
Does your health now limit you in taking care of your personal needs (dress, comb hair, toilet, eat, bathe)?  
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
Does your health now limit you in doing moderate activities, such as moving a table, pushing a vacuum cleaner, 
bowling, or playing golf?   _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFB48_IADL 
Does your health now limit you in taking a shower?   _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFB49_Lower 
Does your health now limit you in going for a short walk (less then 15 minutes)?    _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFB5_Lower 
Does your health now limit you in hiking a couple of miles on uneven surfaces, including hills?   _______ 
5 = Not at all 4 = Very little 3 = Somewhat 2 = Quite a bit 1 = Cannot do 
 
PFB50_IADL 
How much difficulty do you have doing your daily physical activities, because of your health?   _______ 
5 = No difficulty at all 4 = A little bit of difficulty 3 = Some difficulty 2 = A lot of difficulty 1 = Can't 
do because of health 
 
PFB51_IADL   _______ 
Does your health now limit you in participating in active sports such as swimming, tennis, or basketball? 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFB54_IADL   _______ 
Does your health now limit you in going OUTSIDE the home, for example to shop or visit a doctor’s office? 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
Does your health now limit you in doing strenuous activities such as backpacking, skiing, playing tennis, 
bicycling or jogging?  _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 

 
 
 
Page | 15 
Appendix 1-A: PROMIS LE CAT, Continued 
 
PFB8_IADL 
Are you able to carry two bags filled with groceries 100 yards? _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFB9_Lower 
Are you able to jump up and down? _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC10_Lower 
Does your health now limit you in climbing several flights of stairs? _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFC12_IADL 
Does your health now limit you in doing two hours of physical labor? _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFC13_Lower 
Are you able to run 100 yards? _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC20_Lower 
Does your health now limit you in walking one hundred yards? _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
Are you able to walk up and down two steps? _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC32_Lower 
Are you able to climb up 5 flights of stairs? _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC33_Lower 
Are you able to run ten miles? _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC34_Lower 
Does your health now limit you in walking several hundred yards? _______ 
5 = Not at all 4 = Very little 3 = Sometimes 2 = Quite a lot 1 = Cannot do 
 
PFC35_IADL 
Does your health now limit you in doing eight hours of physical labor? _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 

 
 
 
Page | 16 
Appendix 1-A: PROMIS LE CAT, Continued 
PFC36_Lower 
Does your health now limit you in walking more than a mile? _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFC37_Lower 
Does your health now limit you in climbing one flight of stairs?  _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
Are you able to walk at a normal speed?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC39_Lower 
Are you able to stand without losing your balance for several minutes?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC40_Lower 
Are you able to kneel on the floor?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC41_Lower 
Are you able to sit down in and stand up from a low, soft couch?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC45_Lower 
Are you able to get on and off the toilet?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC46_Lower 
Are you able to transfer from a bed to a chair and back?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC47_Central 
Are you able to be out of bed most of the day?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
Are you able to water a house plant?   _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC52_Axial 
Are you able to turn from side to side in bed?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 

 
 
 
Page | 17 
Appendix 1-A: PROMIS LE CAT, Continued 
 
PFC53_IADL 
Are you able to get in and out of bed?  _______ 
5 = Without any difficulty 4 = With a little difficulty 3 = With some difficulty 2 = With much difficulty 1 = 
Unable to do 
 
PFC54_IADL 
Does your health now limit you in getting in and out of the bathtub?  _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
PFC56_Lower 
Does your health now limit you in walking about the house?   _______ 
5 = Not at all 4 = very little 3 = Somewhat 2 = Quite a lot 1 = Cannot do 
 
 
 
 
 
 
 

 
 
 
Page | 18 
Appendix 1-B: Foot and Ankle Ability Measure 
 
 
 
 
 
 
 

 
 
 
Page | 19 
 
Appendix 1-C: Universal Pain Scale 
 
 

 
 
 
Page | 20 
Appendix 1-D: Foot function index pain subscale (0 – 10)
 
 
 

 
 
 
Page | 21 
 
Appendix 1-E: Subject reported outcome measures 
 
 

 
 
 
Page | 22 
Appendix 1-F: Boot Continuance Decision Checklist 
 
2 Weeks after Treatment:            1                     2 
Circle Appropriate Time 
 
 
Ask the Subject about their overall pain from a Scale of 0 – 10.  
Mark the Universal Pain Assessment Tool below. 
 
 
 
 
If the Subject’s assessment of Universal Pain is 3 or less on the scale, the Subject can be advised that they 
may stop using the boot. They should continue to use the orthotic insert in firm soled shoe that does not flex or 
bend – Tennis shoe, platform, wedge, Birkenstock or FitFlopTM sandal. The Subject should be reminded that at 
that point they can resume light activities: Walking on a flat, hard surface (no hiking trails), bicycling and light 
exercises. Subject will massage region twice a day for 2 ½ minutes per each time, total 5 minutes/day. 
 
If the Subject’s pain is 4 or more, they are to continue to wear the boot and orthotic insert provided by Dr. 
Baravarian until their next visit.  
 
Circle the Subject’s response.  
 
Does the Subject agree to continue wearing the Boot:            Yes                      No 
 
Document this Page along with Patient’s other responses.  
 
 

 
 
 
Page | 23 
Appendix 2: Subject Instructional handout  
Plantar Fasciitis  
You have been diagnosed with plantar fasciitis (fashee-EYE-tiss), an 
overuse injury that affects the sole of the foot. A diagnosis of plantar 
fasciitis means you have inflamed the tough, fibrous band of tissue 
(fascia) connecting your heel bone to the base of your toes. 
 
You're more likely to get the condition if you're female, overweight or 
have a job that requires a lot of walking or standing on hard surfaces. 
You're also at risk if you walk or run for exercise, especially if you 
have tight calf muscles that limit how far you can flex your ankles. 
People with very flat feet or very high arches also are more prone to 
plantar fasciitis. 
The condition typically starts gradually with mild pain at the heel bone 
often referred to as a stone bruise. You're more likely to feel it after 
(not during) exercise. The pain classically occurs right after getting up 
in the morning and after a period of sitting. 
If you don't treat plantar fasciitis, it may become a chronic condition. 
You may not be able to keep up your level of activity, and you may 
develop symptoms of foot, knee, hip and back problems because 
plantar fasciitis can change the way you walk. 
Diagnostic Ultrasound and ITU Treatment 
You will be asked to lie on your stomach with your feet hanging over a 
wedge shaped pillow. Acoustic coupling lotion will be applied to the 
bottom of your feet and allowed to soak in. A sonographer will 
complete a diagnostic ultrasound scan on both feet at each clinic visit 
for treatment guidance and follow-up evaluation. During the scan, the 
sonographer will define the treatment area. Additional acoustic 
coupling lotion will be applied and ITU treatment will be completed. The total diagnostic and treatment time is 15-20 
minutes. The first 2 – 3 days after treatment, you may experience a feeling of fullness in your foot and minor discomfort 
while walking. This is normal and should subside within a few days.  
Immobilization Boot and Orthotic 
You have been given an immobilization boot and orthotic.  Use them together for up to 4 weeks after 
treatment as described below:  
1.  Dr. Baravarian’s will provide instructions for wearing the Boot.  
2. When the use of the boot is discontinued, wear the orthotic in supportive firm soled shoes that do 
not flex or bend—Tennis shoe, platform, wedge, Birkenstock or FitFlopTM sandal.  Move the 
orthotic between shoes, and use it with every step you take. 
Massage  
 
Dr. Baravarian will provide instructions for self-massage. 
 
 

 
 
 
Page | 24 
Appendix 3:  Adverse Events Reporting Form 
ADVERSE EVENTS 
      Subject Number_______   Initials________ 
 
Event 
Date 
started 
Date 
ended 
Ongoing/ 
Intermittent 
Severity 
Related 
to  
Study   
Related to 
ITU 
Action 
Taken 
SAE
? 
sig 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Severity:  1. Mild,   2. Mod,   3. Severe 
Relationship:  1. Probably    2. Possibly    3. Probably not  related     4.  Not related 
Action: 1. None    2. Interrupt Study  3. DC study    4.    dose Mod     5. Other Mod     6. Other 
 
 

 
 
 
Page | 25 
Appendix 4: GEN III Therapy System 
 
 
 
  
 
Clinical Prototype GEN III 
 
 
Power:   
3-50 Watts 
 
 
 
Frequency: 
4 – 10MHz 
 
 
Energy/Zone:  up to 5 Joules (tech. mode) 
 
 

 
 
 
Page | 26 
Appendix 5: Diagnostic Ultrasound Imaging System  
 
 
 

 
 
 
Page | 27 
 
 
 
 
 
 
  
 

 
 
 
Page | 28 
Appendix 6: Coupling Gel 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Page | 29