ARTICLE IN PRESS

The Journal of Foot & Ankle Surgery 000 (2018) 1−9

Contents lists available at ScienceDirect

The Journal of Foot & Ankle Surgery

journal homepage: www.jfas.org

Original Research

Intense Therapeutic Ultrasound for Treatment of Chronic Plantar Fasciitis:

A Pivotal Study Exploring Efficacy, Safety, and Patient Tolerance
Evelyn Heigh, DPM, AACFAS1, Laura Bohman, DPM, AACFAS2, Gary Briskin, DPM, FACFAS3,
Michael Slayton, PhD4, Richard Amodei, RDMS5, Keegan Compton, MS6,
Bob Baravarian, DPM, FACFAS7
1
Podiatric Surgeon, Summit Medical Group Arizona, Glendale, AZ
2
Podiatric Surgeon, Podiatry Associates of Cincinnati, Cincinnati, OH
3
Podiatric Surgeon and Co-Director, University Foot and Ankle Institute, Santa Monica, CA
4
CEO, Guided Therapy Systems, Mesa, AZ
5
Director, Clinical Support, Guided Therapy Systems, Mesa, AZ
6
Biomedical Engineer, Guided Therapy Systems, Mesa, AZ
7
Podiatric Surgeon, Co-Director, and Fellowship Director, University Foot and Ankle Institute, Santa Monica, CA

A R T I C L E I N F O A B S T R A C T

Level of Clinical Evidence: 2 Intense therapeutic ultrasound for chronic plantar fasciitis musculoskeletal tissue pain reduction was evaluated in
Keywords: a pivotal clinical trial examining effectiveness, safety, and patient tolerance. In this single-blinded study, 33
heel pain patients received 2 treatments that were 4 weeks apart on plantar fascia tissue along with conservative standard
hypoechoic lesions of care. Patients were followed for up to 6 months after the first treatment, receiving a physical examination and
intense therapeutic ultrasound diagnostic ultrasound at each follow-up visit and completing patient-/subject-reported outcome measure and
plantar fasciitis Foot Function Index surveys. The goal was to reduce overall pain by ≥25% on average and >25% individually.
plantar fasciosis Hypoechoic area changes on diagnostic ultrasound and adverse events were measured. The percentage meeting
therapeutic ultrasound pain reduction criteria at weeks 4, 8, 12, and 26 were 72%, 81%, 86%, and 79%, respectively. Mean pain scores at
ultrasound
each visit were significantly different from baseline (p < .001) at −39%, −49%, −51%, and −44%. Hypoechoic lesions
were found in all patients and decreased in size significantly (p < .05) at weeks 8 and 12 (−56% and −67%). Foot
Function Index scores declined favorably from baseline (p < .001) at all time points (−32%, −46%, −49%, and
−32%). The percentages of patients meeting satisfaction criteria were 72%, 85%, 90%, and 83%. The mean pain score
during treatment 1 was 3.4, and during treatment 2, 2.9. Attrition of only 1 patient owing to pain occurred, after
treatment 1. No adverse events occurred. Intense therapeutic ultrasound for chronic plantar fasciitis is shown to
be effective, safe, and well tolerated in this pivotal clinical trial.
© 2018 by the American College of Foot and Ankle Surgeons. All rights reserved.

Plantar fasciitis is one of the most common clinical conditions some evidence indicates that it is the combination of age and overuse
encountered in the practice of medicine and represents 11% to 15% of that leads to degenerative changes within the fascia, resulting in
all visits (1). Plantar fasciitis is responsible for »1 million patient visits symptoms (4).
per year in the United States (2). Chronic plantar fasciitis (CPF) results The diagnosis of CPF is made clinically based on history and physical
from a degenerative process of the plantar fascia and its surrounding examination (5). Confirmation with diagnostic imaging may be helpful
perifascial structures. The condition may be more appropriately called when the symptoms are atypical or refractory to treatment. Magnetic
plantar fasciosis (3,4). Although the exact etiology of CPF is unclear, resonance imaging (MRI) is a useful diagnostic tool to evaluate for plan-
tar fascia thickening and edema in and around the fascia, findings often
associated with the diagnosis of CPF (6). Diagnostic ultrasound can also
Financial Disclosure: Study sponsor with unrestricted research grant that facilitated
the conduct of the study: Guided Therapy Systems, Inc.; medical device: Actisound Sys- be used to quantify the thickness of the plantar fascia. Several studies
tem−Intense Therapeutic Ultrasound by Guided Therapy Systems, Inc., Mesa, AZ. have shown that patients with CPF have an associated increased thick-
Conflict of Interest: E.H., L.B., G.B., and B.B report research funding from Guided ness of the fascia compared with asymptomatic individuals (7−11).
Therapy Systems, Inc. M.S. reports a leadership position with and stock ownership in Mean thickness in these studies for subjects with CPF range from 4.8 to
Guided Therapy Systems, Inc. R.A. and K.C. have nothing to report.
Address correspondence to: Evelyn Heigh, DPM, AACFAS, Summit Medical Group Ari-
6.5 mm, as opposed to 2.3 to 4.0 mm for subjects without the disease
zona, 5620 West Thunderbird Road, Suite G-2, Glendale, AZ 85306. (7−12). In addition to the evidence of inflammation (8), the presence of
E-mail address: [email protected] (E. Heigh). a hypoechoic lesion in the plantar fascia was noted in 68% to 84% of

1067-2516/$ - see front matter © 2018 by the American College of Foot and Ankle Surgeons. All rights reserved.
https://doi.org/10.1053/j.jfas.2018.10.002
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2 E. Heigh et al. / The Journal of Foot & Ankle Surgery 00 (2018) 1−9

patients with CPF (7,9). Diagnostic ultrasound has been used to quantify Inclusion Criteria
the effectiveness of various treatments for patients with CPF, including
extracorporeal shock wave therapy, nonsteroidal antiinflammatory Male and female adults (18 to 85 years old) with unilateral plantar heel pain and
point tenderness near the medial calcaneal insertion of the plantar fascia for ≥3 months
drugs, and Botox injections (10,12). Another use of diagnostic ultra-
without improvement were considered for inclusion into the study. Subjects were willing
sound may be to examine the plantar fascia to predict response to dif- and able to follow the posttreatment regimen, including an immobilization boot, for 2 to
ferent foot supports. Patients with CPF who have bioconvexity of the 4 weeks after each treatment, along with massage therapy.
plantar fascia may be less responsive to treatment focused on mechani-
cal support of the plantar fascia (13). Exclusion Criteria
Conservative therapy for plantar fasciitis usually consists of rigid
supportive shoes, the use of functional orthotics, and physical therapy Subjects were excluded if they had diabetes or other circulatory issues that might
impede healing, bilateral plantar heel pain, current systemic or local infection (within the
with stretching and massage, which have been shown to effectively past 30 days), previous foot or ankle surgeries, other previous or currently diagnosed
treat symptoms in 90% of patients in <12 months (5). However, »10% foot/ankle pathologies (inflammatory arthritis, gout, neurologic disorders, connective tis-
of patients fail conservative management and continue to have symp- sue disorders, bone spurs, bone fragments, or malignancy); were unwilling or unable to
toms beyond 12 months (4,5,14). Other commonly used therapies complete the post regimen follow-up; were pregnant; or had thick calluses on the heel
(making ultrasound imaging and treatment of the plantar fascia difficult). Patients who
include glucocorticoid injection, shock wave therapy, human tissue had received other previous nonconservative treatment (extracorporeal shock wave ther-
injection therapies with platelet-rich plasma or cryopreserved human apy, biologic injection therapy, surgery) in the symptomatic limb were also excluded.
amniotic membrane, minimally invasive surgical microdebridement
procedures, or formal fasciotomy (15,16). Intense therapeutic ultra- Interventions
sound (ITU) may be a noninvasive treatment that can be used as an
adjunct to speed healing in patients with CPF and as an alternative to Patients presenting with CPF were treated, before the study, with standard-of-care
modalities that included appropriate footwear selection, orthotic use, and physical ther-
other advanced therapies in those with plantar fasciitis.
apy stretching instruction, along with massage for 5 minutes daily. These standard-of-
ITU is an established ultrasound-based therapy in which sound care measures continued while in the study and after treatment with ITU. Additionally,
waves are concentrated and focused into a well-defined specific area of once the study began, all subjects used an immobilization boot for 2 to 4 weeks after each
musculoskeletal tissue. The therapeutic ultrasound energy produces treatment. Although refractory to therapeutic use in the past, previously prescribed
orthotic inserts were allowed to be used within the boot. The decision to continue or dis-
selective thermal coagulative changes over a small controlled area. The
continue the boot was made during the follow-up telephone call 2 weeks after each treat-
surrounding tissue is left unaffected, without impacting the integrity of ment. Subjects massaged the region twice a day for 2.5 minutes per session for a total of 5
the dermis (17−20). The coagulative changes induced are known to minutes per day.
begin the body’s tissue response cascade and promote collagen genera- Treatments were administered by specially trained podiatrists and ultrasound tech-
tion in the targeted anatomy, resulting in pain reduction (21,22). For nologists. The treatment session lasted 15 to 20 minutes. The subjects reclined supine on
an examination table with feet hanging over the end of the table. An average energy
the past decade, ITU has been used in the United States and around the ≤5 joules/thermal zone was administered to the plantar fascia in a matrix pattern with
world for facial aesthetic purposes to induce subcutaneous collagen for- ≤1000 thermal zones distributed along the length and width of the proximal plantar fas-
mation to improve submental and brow appearance without surgery cia (»5 cm2) (Fig. 2). Each thermal zone was <1 mm3 in volume, centered at 10- to 15-
(17,20). Preliminary evidence from other studies suggests there may be mm depth, and formed a matrix of lesions along the plantar fascia. Patients received an
initial treatment at visit 1; 4 weeks later, at visit 2, subjects received a second treatment.
a role for ITU in plantar fasciitis (23). At 12 weeks, for the treatment
The use of the boot and orthotic resumed as defined after the first treatment. ITU treat-
group compared with baseline, pain was reduced by 30%, and hypoe- ments were performed using an Actisound (Guided Therapy Systems, Mesa, AZ).
choic lesion size was reduced by 80%. In the control/sham treatment Diagnostic ultrasound imaging was performed with an FDA 510(k)-cleared ultra-
group at 12 weeks, pain and lesion size were not significantly different sound scanner (Spark System, Ardent Sound, Inc., Mesa, AZ) using a coupling gel
(Polysonic; Parker Laboratories, Inc., Fairfield, NJ). Probes of 10 and 12 MHz were used
from baseline data (23).
with a high-resolution imaging system (Fig. 2). Diagnostic ultrasound imaging was per-
The primary objective of this study was to evaluate the efficacy of formed by podiatrists and ultrasound technologists. All were blinded to the patient clini-
combining ITU with standard conservative care, including posttreat- cal and treatment status.
ment therapy, exercises, and boot immobilization for patients who had
already failed standard conservative care alone and, in most cases, Details of ITU Treatment
failed additional, more aggressive treatment options. A secondary
objective was to evaluate the tolerability and safety of ITU in the treat- Treatments were administered with an Actisound ITU system. The device delivered a
matrix of microcoagulation zones along the plantar fascia from the insertion (Fig. 3), just
ment of CPF. distal to the calcaneus, to the mid-foot region, using a 3.3-MHz probe capable of ≤75 W
It was hypothesized that patients receiving ITU in addition to the at 100-ms duration and 5-Hz pulse repetition frequency. The energy applied per zone
standard of care would have a more rapid resolution of pain, faster was ≤5 joules as selected by the technician. Prior research with the device system
return to activities, and a decrease in intra- and perifascial lesions. This included simulation, verified intensity, and high focal pressure (1200 to 1500 W/cm2,
17.3 MPa at a focal distance of 13 to 15 mm) (23).
investigation was designed as a pivotal study to potentially supply
information that would lead to device clearance to market by the U.S.
Outcome Measures
Food and Drug Administration (FDA).
Subjects completed subject-reported outcome measures (SROMs) and had a focused
Patients, Materials, and Methods physical examination and diagnostic ultrasound at 0, 4, 8, and 12 weeks. At 26 weeks, the
clinical coordinator, using the same SROM questionnaire, administered a telephone sur-
vey. Adverse events, if any, and treatment tolerability were recorded at each visit and 2
This study was conducted at University Foot and Ankle Institute, Santa Monica, CA, a
to 3 days after each treatment.
private group practice of podiatric medicine and surgery. The Western Institutional
Review Board approved the study (IRB 20160753), and verbal and written informed con-
sent was obtained from all subjects. Subject-Reported Outcomes and Structured Physical Examination

Subjects completed validated SROM questionnaires assessing pain, function, and level
Selection of Subjects
of activity before initiating treatment and at 4, 8, 12, and 26 weeks (26-week surveys
were completed by a telephone interview) after starting treatment on scales of overall
Patient recruitment was limited to adults diagnosed with chronic heel pain (>90 improvement, pain, and percentage improvement in activities of daily living (24,25). Sub-
days) for which standard-of-care treatments had failed to reduce pain. This was a jects were also contacted 2 to 3 days after each treatment to assess treatment tolerability
single-blinded, pivotal study, assessing the safety and efficacy of a new device for and document and address adverse effects (if any), as well as 2 weeks after treatment to
treatment of refractory plantar fasciitis. assess progress and determine whether the boot could be discontinued. SROM
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E. Heigh et al. / The Journal of Foot & Ankle Surgery 00 (2018) 1−9 3

Fig. 1. Representative long-axis ultrasound images of the proximal plantar fascia. Normal appearance of asymptomatic plantar fascia (left) and diagnosed chronic plantar fasciitis with
hypoechoic lesion, indicating a lack of fascia integrity at the point of pain (right).

questionnaires assessing each patient’s progress were completed during each follow-up musculoskeletal disorders of the lower leg, foot, and ankle (30). Level of activity was
time point. assessed using the activity subscale of the FAAM. This subscale scores quantitatively the
Pain was assessed using the universal visual analog scale (VAS), the Foot Function level of difficulty that subjects face when they perform basic activities of daily living. It
Index Pain (FFI-P) subscale, and the SROMs. These assessments have been used for pain has been shown to be an accurate and reliable predictor of the activity level while per-
measurement in previous studies of plantar fascia treatments (25−28). On commence- forming day-to-day activities (30). Overall patient satisfaction was also tracked using a
ment of the study, patients were provided with study documentation that included a VAS patient-reported 4-point scale (26,29).
so that data could be collected by telephone. The 10-point VAS was used for assessment
of tolerability and safety. Patient self-reported answers to questions from the FFI-P sub- Assessment of Intra- and Perifascial Hypoechoic Lesions
scale questionnaire have been standardized in several plantar fasciitis−focused publica-
tions (24,26,29). Scores range from 0 to 90, with 0 indicating no pain and 90 indicating
Hypoechoic lesions were imaged using diagnostic ultrasound (Figs. 1 and 3). Volumes
the worst pain imaginable in a variety of daily activities involving use of the plantar fascia.
were calculated at the baseline visit and each follow-up visit by measuring the inferior-
Self-reported scores were taken at baseline and each follow-up time point. The average
to-superior and posterior-to-anterior radii in the long axis and the medial-to-lateral
score for each time point was calculated, and follow-up averages were compared with
radius of the transverse axis and applying the following formula for the volume of an
baseline to calculate the percentage of reduction in score.
ellipse: volume = (4/3)p * r1 * r2 * r3, with r1, r2, and r3 representing the 3 radii above.
The Foot and Ankle Ability Measure (FAAM) has been shown to be a reliable, respon-
Changes to lesion volumes were recorded at each follow-up time point (4, 8, and 12
sive, and valid measure of physical function for individuals with a broad range of
weeks) and compared with baseline by dividing the volume of the lesion at that time
point with the volume of the same lesion at pretreatment baseline.

Hypoechoic Lesion Size and Pain/Function Correlation

To determine the strength of a linear relationship between pain/function score reduc-

tion and lesion size reduction, linear regression analysis was performed. Patient data
related to pain/function score reduction at each follow-up time point compared with
baseline were matched with corresponding data related to lesion size reduction. The
average pain reduction percentage for each follow-up time point was paired with the
average lesion size reduction percentage for the same follow-up time point to generate a
data point for linear regression and the Pearson-correlation coefficient (r) calculation.
The r values between 0.6 and 0.8 were considered strong, and those >0.8 were considered
very strong.

Assessment of Safety and Tolerability

Subject self-assessments of treatment tolerability were recorded during and immedi-

ately after each treatment, again 2 to 3 days later (via telephone survey), and 2 weeks
after treatment (via telephone survey) using a 10-point VAS where 0 = no pain, 1 = slight
pain, and 10 = the patient’s worst imaginable pain. Subjects were asked to report their
current level of pain and the maximum level of pain experienced over the prior few days.
The VAS is the standard for assessing pain for both clinical and research purposes (27).
The study assistants completed telephone surveys, and any adverse effects were
noted and addressed during these telephone calls. Recording of adverse events also took
place at all clinic visits and follow-up telephone calls. Adverse events and serious adverse
Fig. 2. Treatment zone (blue box). events were monitored throughout the study.

Fig. 3. Long-axis ultrasound images of the proximal plantar fascia. Baseline image with hypoechoic lesion (left) and week 12 showing resolving hypoechoic lesion (right).
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Statistical Analysis from the study per the exclusion criteria. Table 1 depicts the patient pop-
ulation.
Data were assessed for variance homogeneity and normality. FFI-P scores and FAAM
scores before and after interventions were compared using Student’s t test. Intra- and Pain Reduction
perifascial lesion volume was measured before and at each posttreatment clinical visit
using diagnostic ultrasound imaging. Paired Student’s t tests were used to determine sta-
tistically significant differences between baseline and subsequent follow-up measure- Patients self-reported pain using the VAS at baseline and at each fol-
ments for self-reported and lesion size measurements. All error bars displayed in graphs low-up time point. Table 2 depicts the number of patients at each base-
are standard error. The level of significance (a) was set to 0.05 before data analysis. line pain score (1 to 10) and the number and percentage of patients
who met the 25% pain reduction goal at each follow-up time point
Results (week 4, 72%; week 8, 81%; week 12, 86%; and week 26, 79%). The per-
centage of patients meeting pain reduction criteria ranged from 72% to
Patients 86% (Fig. 4). The average pain score for each follow-up assessment was
significantly different from baseline for all follow-up assessments
This study was conducted on 33 patients (20 female and 13 male) (p < .001) and demonstrated a 49% (§17) and 51% (§17) reduction at
with chronic symptoms lasting for an average of 19 (range 4 to 48) weeks 8 and 12, respectively, as seen in Fig. 5.
months. The age range was from 31 to 73 years, with a median age of
56 years. One patient withdrew after treatment 1 because she requested Plantar Fascia Hypoechoic Lesion Size
analgesia for treatment 2, and analgesia for pain relief was not part of
the investigational plan. Three other patients did not respond to tele- Perifascial or intrafascial hypoechoic lesions were noted on all
phone follow-up or return for repeat appointments, eliminating them patients. After treatment, the size of the hypoechoic lesions significantly
decreased. The size of the hypoechoic lesions was measured over time
Table 1
and progressively decreased in size to week 12, the last diagnostic ultra-
Patient demographics
sound of the study (Fig. 6). The percentage decrease in lesion size from
Mean age, y (range) 56 (31−73) baseline was statistically significant at weeks 8 and 12 (p < .005), reduc-
Mean length of reported symptoms, mo (range) 19 (4−48) ing by 56% (§20) and 67% (§33), respectively. When a correlation of
M/F sex, n (%) 13 (39.4)/20 (60.6)
average reduction in pain score (using the VAS) with average lesion size
reduction was analyzed for follow-up time points 4, 8, and 12, a strong
Table 2
Patient-reported pain scores by visit and percentage meeting pain reduction criteria

Baseline Baseline Total No. Meeting Pain Total No. Meeting Pain Total No. Meeting Pain Total No. Meeting Pain
Pain n Value Responses Reduction Criteria Responses Reduction Criteria Responses Reduction Criteria Responses Reduction Criteria
Scores at Week 4 at Week 4 at Week 8 at Week 8 at Week 12 at Week 12 at Week 26 at Week 26

10 2 2 2 2 2 2 2 2 2
No. and Percentage of Patients Reporting

9 2 2 2 2 1 2 2 2 2
8 9 9 6 7 5 8 6 8 5
7 3 2 1 2 2 3 2 3 3
6 2 2 2 2 2 2 2 2 2
at Least 25% Pain Reduction

5 2 2 1 2 2 2 2 2 2
4 4 4 3 3 1 4 3 4 3
3 3 3 2 3 3 3 3 3 2
2 6 6 4 3 3 3 3 3 2
1 0 0 0 0 0 0 0 0 0
Total 33 32 23 26 21 29 25 29 23
Responses
Meeting Pain
Reduction 72% 81% 86% 79%
Criteria

Fig. 4. Percentage of patients meeting 25% pain reduction criteria.

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Fig. 5. Average visual analog scale pain score by visit (standard error noted). Average pain score reduction compared with baseline: week 4, 39%; week 8, −49%; week 12, −51%;
week 26, −44%.

Fig. 6. Average lesion size by visit (standard error noted). Average lesion size reduction compared with baseline: week 4, −27%; week 8, −56%; week 12, −67%.

Fig. 7. Correlations between lesion size and visual analog scale pain score.

correlation was identified (Fig. 7). For weeks 8 and 12, patients had a follow-up visit, as depicted in Fig. 8. A highly significant difference (p <
strong positive correlation between these 2 measures on an individual .001) for all follow-up time points was found compared with baseline.
basis (r = 0.84 and 0.64, respectively). An increase in FAAM (Fig. 9) scores and FAAM Daily Activity scores
(Fig. 10) beginning at the first follow-up visit continued throughout the
6-month follow-up period. SROMs of how patients felt and how much
Additional Parameters
pain they had at each time point in the study are depicted in Table 3. At
every time point, most patients felt better and experienced at least a
A decline in the Foot Function Index (FFI) score from baseline
25% improvement in pain and daily activities. The proportion of
showed favorable clinical improvement, and this was seen for each
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6 E. Heigh et al. / The Journal of Foot & Ankle Surgery 00 (2018) 1−9

Fig. 8. Average Foot Function Index score by visit (standard error noted). Average Foot Function Index score compared with baseline: week 4, −32%; week 8, −46%; week 12, −49%; week
26, −32%.

Fig. 9. Average Foot and Ankle Ability Measure score by visit (standard error noted).

patients who felt improvement in these categories increased at each Additionally, patients reporting satisfaction with major reservations
subsequent time point. were tracked. This same figure also shows that with that category
Patient satisfaction on an overall basis was tracked at each of the fol- added, patient satisfaction was recorded as between 88% and 97%.
low-up time points using a 4-point scale. Subjects had the options of
choosing dissatisfied, satisfied with major reservations, satisfied with
minor reservations, and totally satisfied. At each time point, patient sat- Patient Tolerance and Safety
isfaction based on these criteria was between 72% and 90% (Fig. 11).
No anesthetic was provided during the ITU treatments. Treatment
tolerance was tracked via a patient-reported VAS pain score 10 to
20 times during each treatment. Fig. 12 shows the percentage of
patients reporting no pain and minor, moderate, or severe momentary
pain during treatment. For treatment 1, the average pain score was 3.4;
for treatment 2, the average pain score was 2.9. No adverse events were
recorded over the 9-month trial duration.

Discussion

Plantar fasciitis is very common. Unfortunately, conservative ther-

apy does not render all patients pain free, and chronic pain leaves many
searching for relief (1,2). Currently, if nonprocedural therapy is insuffi-
cient to resolve symptoms, a stepwise progression of therapies fre-
quently includes corticosteroid injections, shock wave therapy, human
tissue injections with plasma-rich platelets or cryopreserved human
amniotic membrane, microdebridement surgery, or fasciotomy
(4,5,14−16,24). Conceivably, if an additional effective therapy were
available, pain could be reduced, and the journey of progressive and
Fig. 10. Average Daily Activity score by visit (standard error noted). more invasive therapies could be halted. ITU may fulfill this goal.
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Table 3
Patient self-reported outcome measures questionnaire results by week and percentage of patients meeting criteria

Week “Compared to My Initial Visit. . .

. . .I Feel . . .I Have No/ . . .I Have >25% . . .Heel Pain Is . . .I Have >25% Improvement
Better” Less Pain” Improvement in Heel Pain” Much/All Better” in Daily Activities”

4 66% 75% 56% 47% 53%

8 85% 85% 73% 58% 73%
12 79% 83% 76% 62% 72%
26 86% 93% 86% 79% 86%

Fig. 11. Percentage of patients meeting overall treatment satisfaction criteria.

Fig. 12. Patient-reported treatment pain scores by percentage of patients.

Various types of ultrasound have been used to treat soft tissue injuries elastic fibers in the reticular dermis (17−20). Laboratory research has
since the 1930s (31). Most of such conventional ultrasound treatments shown that ITU can improve healing of a damaged Achilles tendon in a
(diathermy) involve diffuse, low-energy, long-duration pulses resulting in rabbit model. Preliminary results showed an increase in markers for
the warming of tissues under the ultrasound beam. ITU is a recently devel- wound healing (eg, Vascular Endothelial Growth Factor A, Tumor Necrosis
oped ultrasound-based therapy in which sound waves are concentrated to Factor Alpha, Interleukin-1 Beta, and Transforming Growth Factor Beta 1)
produce selective thermal coagulative change over a small area while and a decrease in markers for scar tissue formation (eg, Collagen Type I
leaving the remaining regions unaffected (19). ITU has been used clinically Alpha, Collagen Type I Alpha 2, Collagen Type II Alpha 1) in injured rabbit
for treating the facial skin for the past decade, and it has received CE mark tendon treated with ITU compared with untreated rabbit tendons (21,22).
and U.S. FDA clearance to market (32) for nonsurgical brow and submental These results have led us to explore the possibility of using ITU to treat
tissue lifting. More than 3 million patients worldwide have been treated patients with CPF.
using this technology (33). Clinical studies have shown that 85% of subjects In this pivotal clinical trial, the study objectives were met. After fail-
receiving this treatment on facial skin tissue showed an improvement in ing conservative therapy, ITU was administered and the reduction in
facial lifting with no significant pain, erythema, inflammation, or scarring pain scores of ≥25% occurred in 72%, 81%, 86%, and 79% at the time
(34). Histologically, it has been shown that ITU induces the production of points of 4, 8, 12, and 26 weeks after treatment, respectively (Fig. 4).
dermal collagen with thickening of the dermis and straightening of the Similarly, mean pain scores at each visit were significantly different
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8 E. Heigh et al. / The Journal of Foot & Ankle Surgery 00 (2018) 1−9

from baseline (p < .001) at −39%, −49%, −51%, and −44% (Fig. 5). As performed, and validation of the specific depth of tissue treated with
hypothesized, FFI scores declined favorably from baseline (p < .001) at the device was not reported. The authors specifically noted that ultra-
all time points evaluated (Fig. 8). All patients had hypoechoic lesions, sound doses of differing parameters might produce different conclu-
and they decreased in size significantly (p < .05) at weeks 8 and 12, sions (40). Other diathermy studies have been conducted with similar
−56% and −67% on average (Fig. 6). These findings are consistent with results (41).
the original feasibility study (23). The very encouraging sign was the Overall, although several studies on diathermy ultrasound in plantar
subjects meeting satisfaction criteria of 72%, 85%, 90%, and 83% at subse- fasciitis have been reported, differences in patient characteristics, the
quent time points (Fig. 11). No adverse events occurred. The procedure dose of energy applied, the mode of administration (pulse or continu-
was well tolerated, with early attrition of only 1 patient in the study. ous), the presence or absence of a standardized treatment protocol, con-
Comparing trials and the results of ITU is difficult because even if the firmed localization of energy delivery to the plantar fascia, and other
patients enrolled are similar, the details of treatment may differ. Con- details between the studies make comparisons difficult.
ventional therapeutic ultrasound (diathermy) treatment trials may dif- In a 37-patient study in 2007 comparing extracorporeal shock wave
fer by the specific device used, the dose applied (delivered pulses of to diathermy ultrasound therapy for heel pain, the authors found that
energy intensity, frequency, depth of penetration, or duration), diagnos- 37% had a decline in pain (using the VAS score) in the shock wave group
tic ultrasound monitoring, the systematic approach to the plantar fascia and 24% in the ultrasound group, and the pain increased 3% in the con-
field specifically treated, the number of sessions energy is applied, and trol group (p = .002). Ultrasound therapy was administered 3 times a
recovery time between treatments. week at a frequency of 1 MHz with an intensity of 1 W/cm2 (Phyaction
Despite some potential variables between treatment trials, it is pos- 190i, Uniphy, Netherlands) for 5 minutes each session, and an ankle
sible to compare this trial with another study (23) with the same splint post therapy was used. A detailed energy application location
patient selection criteria, an identical device, identical depth of penetra- strategy was not reported. The authors noted improvement with ultra-
tion, and identical energy application. This trial differed in that the sec- sound and different results from other studies owing to treatment
ond application of therapy was at 2 weeks after initial treatment rather parameters or outcome parameters (42).
than our 4 weeks, and the patient-reported monitoring used the FFI-P A recent 60-patient study in CPF of at least 6 months’ duration explored
outcome measure. The trial also compared results with a sham treat- the efficacy of shock wave therapy and compared it with low-level laser
ment session in a double-blind fashion. In the 41-patient study, the 29 therapy and therapeutic diathermy ultrasound. Patients receiving shock
patients being actively treated had a significant reduction in the pain wave therapy had a 65% improvement on MRI findings or clinical response
score and 100% satisfaction. In the treated group, there was statistically that was comparable to low-level laser therapy (70.6% improvement) and
significant reduction in hypoechoic area size (−81%) and a 54% decrease more effective than diathermy ultrasound, which had only 23.5% improve-
in the FFI score at 12 weeks compared with baseline metrics. In con- ment. The ultrasound portion of the study evaluated therapy by a device
trast, the control/sham treatment group had average hypoechoic lesions that delivered 2 W/cm2 and was used at 5 sessions a week for 3 consecutive
increase (+26%), and average FFI-P scores were slightly reduced (23). weeks (BTL-5000 SWT combination device, BTL, Ankara, Turkey). A fre-
When examined by diagnostic ultrasound, a large portion of patients quency of 1 MHz was used at a power of 2 W/cm2 to the painful heel area
with CPF are found to have hypoechoic lesions in or around the proxi- and the myofascial junction at the dorsum of the heel for 5 minutes a ses-
mal plantar fascia (35). This study found a reduction in size of these sion. This differed from our study in the dose of energy applied (intensity of
lesions and the correlation of size deduction to pain reduction to be sig- acoustic waves delivered at each session, total energy delivered) and sys-
nificant. The clinical meaning of this finding is uncertain but may pro- tematic application of therapy (43).
pose a possible association of hypoechoic lesions in heel pain. MRI has Our study had several limitations. By design, it is a pivotal clinical
been used to study the plantar fascia in plantar fasciitis, and typical trial to explore the effectiveness and safety of a new device and new
findings include plantar fascial thickening, intrafascial edema and approach to treating CPF. This was a descriptive treatment study of an
edema surrounding on the fascia on T2 weighted images (primarily the intervention without a concomitant sham or active alternate therapy
proximal aspect of the fascia is edematous), and increased intrafascial comparator control group. The trial was small, with 29 patients success-
T1 signal. Fascial thickening is defined as >3 mm, with some cases fully completing the 2 treatments and follow-up assessments. Small tri-
having thickening up to 7 and 8 mm. The thickening is usually fusiform als such as these are necessary to develop larger studies and fine-tune
and not nodular. Sometimes marrow edema of the calcaneal tuberosity research questions.
is present on MRI (36,37). Diagnostic ultrasound in plantar fasciitis was In conclusion, in this pivotal clinical trial, ITU for CPF musculoskele-
evaluated in a systematic review that identified 34 relevant quality tal tissue pain reduction was effective, safe, and well tolerated. In addi-
studies. The review concluded that diagnostic ultrasound is a reliable tion to having reduced pain and clinical improvement, the subjects
technique for assessing plantar fascia thickness, monitoring the effect were highly satisfied with the therapy. Based on this preliminary infor-
of therapeutic interventions, and guiding therapeutic interventions in mation, larger studies to clarify the possible role of ITU in the treatment
patients with plantar fasciitis (38). With further development of high- of CPF are warranted.
resolution diagnostic ultrasound, it is hopeful that better understanding
of the plantar fascia, its pathology, and the natural history of changes in
Acknowledgments
treated and untreated plantar fasciitis will emerge.
Using diathermy ultrasound therapeutically to try to help patients
The authors thank the study sponsor, Guided Therapy Systems, Inc.,
with foot and heel pain has been reported since the mid-1970s (39).
for an unrestricted research grant that facilitated the conduct of this
Clinical studies have shown varying treatment programs and response
study. The authors recognize the entire University Foot and Ankle Insti-
rates. In a 2006 study of 19 patients with heel pain, some bilateral, 13
tute team for their excellent patient care and assistance in conducting
patients received therapy with an ultrasound device and 13 received
this clinical trial.
placebo. Although more patients had pain relief in the treated group
than with placebo, there was no statistical difference. This type of ultra-
sound treatment (diathermy) involves diffuse, low-energy, long-dura-
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