Katzap2018 PDF

Additive Effect of Therapeutic Ultrasound in the treatment of Plantar Fasciitis: A
Randomized Controlled Trial
Yigal Katzap MPT1,2, • Michael Haidukov BPT3 • Olivier M. Berland, MSc.PT4•
Ron Ben Itzhak, MD5 • Leonid Kalichman PT, PhD1
1
Department of Physical Therapy, Recanati School for Community Health Professions,
Faculty of Health Sciences at Ben-Gurion University of the Negev, Beer-Sheva, Israel;

2
Physical Therapy Outpatient Clinic, Maccabi Health Care Services, Rehovot, Israel;
Downloaded from www.jospt.org at USD Univ Libraries on July 12, 2018. For personal use only. No other uses without permission.
3
Physical Therapy Outpatient Clinic, Maccabi Health Care Services, Ashdod, Israel;
4
Physical Therapy Outpatient Clinic, Maccabi Health Care Services, Ashkelon, Israel;
5
Maccabi Health Care Services, MOMA, Israel
Copyright © ${year} Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Conflict of interest: None declared. The authors certify that they have no affiliations with or
financial involvement in any organization or entity with a direct financial interest in the
subject matter or materials discussed in the article.
Funding source: None.

Journal of Orthopaedic & Sports Physical Therapy®
The study was approved by the Ethical (Helsinki) Committee of the Maccabi Healthcare
Services and the Thesis Committee of the Ben Gurion University of the Negev. The study is
registered at ClinicalTrials.gov (registration number NCT02679326).
Corresponding author: Leonid Kalichman, PT, Ph.D., Department of Physical Therapy,
Recanati School for Community Health Professions, Faculty of Health Sciences, Ben-Gurion
University of the Negev, P.O.B. 653, Beer Sheva, 84105, Israel. Tel.: 972-52-2767050; E-
mail: kleonid@bgu.ac.il.
Word count: 3812
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Additive Effect of Therapeutic Ultrasound in the treatment of Plantar Fasciitis: A
Randomized Controlled Trial
Conflict of interest: None declared. The authors certify that they have no affiliations with or
financial involvement in any organization or entity with a direct financial interest in the
subject matter or materials discussed in the article.
Funding source: None.

2
ACKNOWLEDGMENTS: The authors would like to thank Sandra Meron, Dr. Daniel
Deutscher, Merav Grin-Shamay and Yehudit Meltzer from the Maccabi Health Services for
at the beginning of the study. We would also like to thank the heads of the their guidance
Physiotherapy Institutes of Rehovot, Ashdod, and Ashkelon, Rache Bush and Ayelet Saar,
Hana Shroitman and Amit Epshtein, and of course, the entire staff of physical therapists at
the three centers for their assistance in recruitment and providing treatment to the patients.
The authors thank Mrs. Phyllis Curchack Kornspan for her editorial services.
3
1 ABSTRACT
2 STUDY DESIGN: A prospective, randomized, double-blinded, placebo-controlled clinical
3 trial.
4 BACKGROUND: Plantar fasciitis is the main cause of pain in the plantar surface of the heel.
5 One of the most common conservative treatment modalities used by physical therapists
6 worldwide is therapeutic ultrasound, despite the scarce evidence of its efficacy in the
7 treatment of plantar fasciitis.
8 OBJECTIVE: To evaluate the additive effect of therapeutic ultrasound in the treatment of

9 plantar fasciitis in terms of pain, function, and quality of life.
10 METHODS: 54 patients afflicted with plantar fasciitis, aged 24-80, who met the inclusion
11 criteria, were randomized into an active intervention group and treated by self-performed
12 stretching of the plantar fascia and calf muscles in addition to therapeutic ultrasound. The
13 control group was treated with the same stretching exercises with an addition of sham
14 ultrasound. Both groups received eight treatments, twice weekly. Outcome measures included
15 a Numeric Pain Rate Scale (NPRS), the Foot & Ankle Computerized Adaptive Test (CAT)
16 and an algometric test.

17 RESULTS: Both groups showed statistically significant improvement in all outcome
18 measures (P<0.001, both groups). At the completion of the study, no statistically significant
19 differences were found between the groups in any of the outcomes.
20 CONCLUSIONS: The addition of therapeutic ultrasound did not improve the efficacy of
21 conservative treatment for plantar fasciitis, therefore, we recommend excluding therapeutic
22 ultrasounds from the treatment of plantar fasciitis. We agree with the results of previous
23 studies that stretching may be an effective treatment for healing plantar fasciitis.
24 Level of Evidence: Therapy, Level 1b.
25 KEYWORDS: heel pain; therapeutic ultrasound; treatment; physical therapy.
4
26 INTRODUCTION
27 The plantar fascia is a thick, non-elastic, multi-layered connective tissue crossing the
28 plantar part of the foot.24 Plantar fasciitis is the main cause of pain in the plantar surface of
29 the heel. It has been estimated that this problem is involved in approximately 11%-15% of all
30 foot pain complaints requiring medical attention.25 Other names for this condition include
31 painful heel syndrome, heel spur, runner's heel, subcalcaneal pain, calcaneodynia and
32 calcaneal periostitis.37 In the United States, more than two million people are treated for
33 plantar fasciitis every year. It is estimated that approximately 10% of the US population will
34 experience plantar fasciitis regardless of sex, age, ethnicity or level of activity. This
35 phenomenon is seen in active people, such as runners and military personnel, however, it also
36 appears in the general population, especially women aged 40-60.6,37
37 Plantar fasciitis can be a painful and exhausting condition frustrating for both the
38 patient and the physical therapist. The most common signs for identifying plantar fasciitis are
39 pain and tenderness in the medial tubercle of the heel bone as well as an increase in pain
40 when taking the first steps in the morning and pain in prolonged weight bearing.30
41 Conservative treatment options for plantar fasciitis include joint and soft-tissue
42 manipulations, TENS, patient training, taping, night splints, stretching, ice, heat, muscle
43 strengthening, and insoles. In addition, shock wave therapy, injections, medications and even
44 surgical interventions are utilized in the event that conservative treatments are ineffective. At
45 present, researchers have not determined the most effective combination of treatments for
46 treating plantar fasciitis due to the dearth of high-quality research.17 In 2003, a systematic
47 review of 19 randomized clinical trials (RCTs) evaluated the effectiveness of treatments for
48 plantar heel pain, of which seven compared active treatment with placebo or no treatment at
49 all. Treatments included insoles, heel pads, corticosteroid injections, night pads and shock
50 waves. The authors found limited evidence of effectiveness using the reviewed interventions.
5
51 Treatments used to reduce heel pain seem to produce only marginal gains over no treatment
52 and control therapies such as stretching. All RCTs included in the review had methodological
53 problems with the study design or small sample sizes.11
54 In 2014, a systematic review that included 26 trials (23 of them controlled clinical
55 trials), assessed subjects who experienced pain especially in the morning, by a visual analog
56 scale (VAS) or numeric scales (used as the main outcome measure). The interventions
57 included shock wave therapy, stretching and manual treatments, therapeutic ultrasound, laser,
58 taping, acupuncture, electrical stimulations, insoles, magnetotherapy and elastic taping. Of

59 the 23 studies, 14 RCTs compared the active treatments (monotherapy or combination of
60 several treatment techniques) a single treatment or placebo. The authors concluded that a
61 combination of several treatment techniques appeared to be more effective than monotherapy.
62 However, due to the heterogeneity of techniques, the different number of sessions or diverse
63 duration of treatments it was impossible to perform a quantitative statistical analysis.12
64 One of the most widely used electrical devices among physical therapists in Israel and
65 worldwide is therapeutic ultrasound.26,36,41,42,44 Biologically, therapeutic ultrasound raises
66 tissue temperature and metabolism, softens the tissues, increases blood circulation, increases
67 the chemical activity of the tissues, increases the permeability of the cell membranes,
68 modulates the molecular structures and the rate of pulsation and protein production, all
69 potentially affecting the speed of tissue recovery.40 There is insufficient high-quality
70 scientific evidence to support the clinical use of therapeutic ultrasound in treating
71 musculoskeletal problems.42
72 Only two studies have examined the efficacy of ultrasound in the treatment of plantar
73 fasciitis. One compared active therapeutic ultrasound with sham ultrasound treatment10 and
74 the second supplemented calf muscle stretching to both groups.43 Both studies found that the
75 addition of active therapeutic ultrasound therapy had no advantage over sham treatment in
6
76 cases of plantar fasciitis. However, the methodology in both studies was problematic. In the
77 first study, researchers used ultrasound parameters of 0.5 W/cm2, 3 MHZ, pulsed 1:4, for 8
78 minutes.10 These parameters may not have allowed the ultrasound waves to deliver energy to
79 the target tissues. The plantar fascia, according to our examination (which will be described
80 later) lies at a depth of >2 cm, therefore, the frequency and intensity of the ultrasound should
81 be much higher.35 In addition, pulsed ultrasound, used especially on chronically ill patients,
82 may also be unsuitable since it prevents the raising of tissue temperature thus, reducing the
83 thermal effect of treatment.2

84 In the second study, the researchers employed parameters of 2 W/cm2, 1 MHZ, and
85 continuous wave,46 however, the technique for placing the ultrasound transducer was static,
86 which is not a commonly used technique and may increase the chances of producing pain and
87 causing a detrimental effect to nearby tissues. The ultrasound was applied for 3 minutes at
88 each painful point, which may be insufficient. In addition, the number of subjects in both
89 studies was low which rendered the statistical power of these studies questionable, and both
90 studies included separately each foot in the randomization in patients with bilateral plantar
91 fasciitis was separately included in the randomization, which could interfere with the blinding
92 in cases where each foot received different treatments.
93 In conclusion, high-quality RCTs need to assess the efficacy of the additive effect of
94 therapeutic ultrasound in the treatment of plantar fasciitis. Therefore, the aim of this study
95 was to evaluate the additive effect of therapeutic ultrasound in treating plantar fasciitis in
96 terms of pain, function, and quality of life. We hypothesized that therapeutic ultrasound
97 employing parameters which increase heat in the target tissue (continuous wave, 1.8 W/cm2
98 and frequency of 1 MHZ) and stretching exercises will significantly improve pain, function,
99 and quality of life in patients with plantar fasciitis more than stretching and sham therapeutic
100 ultrasound.
7
101 METHODS
102 Design
103 An interventional, prospective, double-blind randomized controlled trial.
104 Setting
105 The study was performed at the Maccabi Healthcare Services Physical Therapy Clinics in
106 Rehovot, Ashdod and Ashkelon, Israel.
107 Sample
108 Recruitment took place from June 2015- May 2017. The study comprised patients registered
109 at the Maccabi Healthcare Services diagnosed with plantar fasciitis, plantar heel pain,
110 calcaneal spur, foot pain or heel pain syndrome and referred for physical therapy by an
111 orthopedist or general practitioner.
112 Inclusion criteria required patients to be ≥18 years of age, with a primary report of pain at the
113 bottom of the heel and with the following clinical features:3,8,28 1) a gradual development of
114 pain (with no trauma); 2) pain generated by carrying weight or by local pressure; 3) an
115 increase in pain in the morning upon taking a few steps or after prolonged non-weight
116 bearing; and 4) symptoms decreasing with slight levels of activity, such as walking.
117 Additional criteria were: a numerical pain rating scale (NPRS) of morning pain >3 (to prevent
118 the floor effect), sensitivity or swelling in the proximal planetary region of the fascia or
119 medial plantar tuberosity of the calcaneal bone.
120 Exclusion criteria: peripheral neuropathy, calcaneal cysts or tumors, calcaneal
121 fractures or stress fractures, use of steroids during the past 6 months, foot surgery performed
122 the year prior, infection or diabetic foot, tarsal tunnel syndrome (TTS), fat-pad syndrome,
123 pregnancy and unavailability in the coming month.
124 The study was approved by the Helsinki Committee of Maccabi Healthcare Services,
125 Beit Balev Nursing Home, Bat Yam, Israel. All patients signed an informed consent form
8
126 prior to participation. The rights of the subjects were protected. The study has been registered
127 at ClinicalTrials.gov (registration number NCT02679326).
128 Sample Size Estimation
129 Since two previous studies were underpowered,10,43 we decided to commence recruitment
130 with 60 subjects (30 in each group), with the possibility to refine sample size calculations
131 after mid-term data analysis. Using the Power & Sample Size software (PS Power and
132 Sample Size Calculations, Version 3.0, 2009) we performed sample-size calculations based
133 on the following parameters: a 2-sided test and power = 0.8, α = 0.05. The main outcome
134 measure was the NPRS of morning pain. We chose to apply the mean difference of 2
135 (representing the clinically important difference in NPRS).14 In mid-term statistics, the
136 standard deviation of the NPRS was 2.48, thus establishing the need for 25 subjects in each
137 group. Due to the possibility of dropouts, 54 participants were recruited (27 participants per
138 group).
139 Allocation
140 The allocation of patients to the active intervention and control groups was performed using a
141 10-patient block randomization software

142 (mahmoodsaghaei.tripod.com/Softwares/randalloc.html). The results of the randomization
143 were recorded, placed in sealed envelopes and kept in the director’s office of the physical
144 therapy clinics. After the patient signed an informed consent and was tested for inclusion and
145 exclusion criteria, he/she was assigned to a specific group by the head of the physical therapy
146 institutions in Rehovot, Ashdod, or Ashkelon.
147 Outcome Measures
148 Baseline evaluation included demographic data collection, medical history, and physical
149 examination. Demographic data included age, sex, weight, height and BMI (calculated as
150 weight in kg divided by height in meters squared), the affected side (when a bilateral problem
9
151 occurred, the more symptomatic side was chosen), duration of time the patient has suffered
152 from the problem, physical activity (participating or not, and how many hours a week) (Table
153 1).
154 Physical examination included palpation performed for local heat or swelling and for local
155 pain at the medial calcaneal tuberosity. Participants with clinical symptoms of pain in the
156 middle of the heel, aggravating when walking on hard surfaces or with a history of heel blow
157 were excluded for suspicion of fat pad syndrome.43 Three differential diagnosing signs for
158 TTS were assessed to exclude this pathology: the presence of numbness or burning pain,
159 Tinel sign and neurodynamic test. The Tinel sign was found to be positive in TTS and medial
160 plantar nerve entrapment by Schon and Baxter in 1990.40 The modified straight leg raising
161 test with dorsiflexion/eversion was found to be a valuable tool to differentiate plantar heel
162 pain of neural origin from plantar fasciitis. Since none of these tests can provide an accurate
163 answer, participants suspected by only one positive test of TTS were excluded.
164 Outcome measures were the level of pain during the first few steps in the morning and during
165 the day (rated by the NPRS), pressure pain threshold and perceived functional level (Foot &
166 Ankle CAT). The main outcome was morning pain rated by the NPRS. Patients were asked to
167 assess the intensity of pain when taking the first steps in the morning. The scale ranges
168 between 0 and 10 (0 = "no pain" and 10 = "unbearable pain"). The NPRS is not age-
169 dependent, contains a low risk for error, a high face validity and convergent and criterion
170 validity compared to other pain scales.16,23 The NPRS is considered a gold standard for self-
171 assessment of pain and is a reliable and accurate tool.29 A 2-point decrease or a 30%
172 reduction found on the NPRS represents a significant clinical change.5,14
173 The second outcome measure was the average pain felt during the day as measured by
174 the NPRS. The third outcome measure was the Foot & Ankle CAT test, which assessed the
175 perceived functional level of the patient. This test was incorporated into the report since, in
10
176 many studies, the state of overall functioning and health-related quality of life is considered
177 the gold standard of treatment outcomes.18 The Foot & Ankle CAT consists of a
178 computerized adaptive questionnaire, collecting patient results, in which the computer adjusts
179 the questions to the patient by matching the difficulty of the question to the patient's ability.
180 The subject ceases to answer the questions when he/she has answered three consecutive
181 questions corresponding to a certain functional level. Hart et al20 observed that after an
182 average of 6.6 questions, the questions ceased. The advantage of the adjusted questionnaire is
183 the reduced number of questions asked and the reduced amount of time needed for filling out
184 the questionnaire. The Foot & Ankle CAT is derived from the Lower-Extremity Functional
185 Scale (LEFS) questionnaire.20 consisting of 18 questions representing functional activities,
186 such as "walking between rooms". The patient is asked to rate his/her ability to perform any
187 action using a 5-point scale from "very difficult or unable to perform the action" to "no
188 difficulty". Upon completion of the questionnaire, a score of 0-100 is given; a higher score
189 indicates better functioning. The CAT showed good construct 20 and good identification
190 validity.19 An average change of ≥8 points in functional status was viewed as a significant
191 clinical change.45

192 To assess pain pressure threshold, algometry was used to measure the minimum
193 pressure required to produce pain. The disc was placed vertically on a pain pressure point.
194 The examiner then increased the intensity of the pressure until initial pain occurred (the stage
195 at which the feeling of stress became painful). The score was determined by averaging three
196 continuous measurements. The algometer enables an objective assessment of pain, in addition
197 to the NPRS which is a subjective tool. The algometry test was found to be valid and reliable
198 when measurements were repeated (inter-rater, intra-rater) on healthy people.15 High
199 reliability was found for algometer testing in an average calculation between three repeated
200 measures: ICC = 0.91 (95% CI 0.82, 0.97).4 The algometer measurement was performed
11
201 twice during the study, the first during the initial evaluation and the second at the final
202 evaluation.
203 Intervention
204 Stretching: Many studies have suggested that stretching of the triceps surae muscles should
205 be an essential part of plantar fasciitis treatment.31,33 The purpose of the stretching is to
206 release the tension created in the plantar fascia or stiffness of the Achilles tendon, both of
207 which connect to the calcaneus bone.43 Both groups in our study received a verbal
208 explanation and printed pages with images and instructions as to how to perform stretching of
209 the plantar fascia and triceps surae. Stretching exercises used in our study were based on
210 previous studies,13,32 that found effective pain reduction and functional improvement. We
211 chose the regiment of twice daily (once before walking in the morning and once during the
212 day, after sitting for a long period of time or at the end of the day), 5 repetitions of 20
213 seconds. Subjects performed the exercises during their first treatment session, supervised by a
214 physical therapist. The plantar fascia stretch was performed seated. Two stretching exercises
215 of the triceps surae were performed against a wall (once with a straight knee and once with a
216 bent knee), twice a day, 5 sets of 20 seconds static at a time.

217 Therapeutic ultrasound: Because we found no publications on depth of plantar fascia, to
218 assess the depth of the plantar fascia connection to medial calcaneal tuberosity prior to the
219 current study, we examined 10 CT scans of normal feet (5 of males and 5 of females) and
220 found that the average depth of plantar fascia was 2.1±0.2 cm (Range: 1.80-2.40, Mean
221 standard error 0.06). The test was performed at the Barzilai Hospital by a researcher
222 experienced in CT evaluation (L.K.) together with a board-certified radiologist, using
223 anonymized CT scans from the archive.
224 The study group, in addition to stretching, were treated with 8 minutes of therapeutic
225 ultrasound with a frequency of 1 MHZ, continuous current at a pulse intensity of 1.8 W/cm2
12
226 (if the sensitivity level was too high and it hurt the patient, then the intensity was reduced by
227 the therapist). The selection of the parameters was based on the previous studies10,46 and
228 according to the recommendations of Ultrasound Therapy Dose Calculations website
229 (http://www.electrotherapy.org/modality/ultrasound-dose-calculation). We also used an
230 online calculator for Ultrasound Dosage by Sonodose
231 (http://www.sonodose.dk/SONODOSE-lite/SONODOSE-lite.htm). Because the previous
232 studies10,46 showed no effect of ultrasound, we intended to maximize therapeutic effects (both
233 thermic and non-thermic) in a target tissue. To maximize the thermic effect, we choose the
234 continuous mode. It is also in accord with a common recommendation for chronic conditions.
235 According to the recommendations of both sites, in lesions deeper than 2 cm, use of 1Mhz
236 frequency is recommended. When the targeted tissue is in average depth of 2.1 cm (of mixed
237 tissues: skin, fat pad) and taking into account the thickness of plantar fascia,1 1.8 W/cm2 was
238 the optimal power to reach the therapeutic intensity (in the site of lesion) of 1 W/cm2. The
239 treatment time of 8 minutes is slightly higher than recommended by the online calculator, and
240 by our clinical practice (5 minutes), but we choose it because it was used in a previous
241 study10, and we wanted to use highest possible parameters.

242 The control group, in addition to stretching, was treated with 8 minutes of negligible
243 intensity ultrasound. Parameters were a frequency of 3 MHZ, pulse intensity 0.1 W/cm2 and
244 duty cycle of 1:4 (pulsed). With these parameters, the ultrasound energy did not penetrate
245 beyond a few millimeters and did not reach the target tissue. Both groups received 8
246 treatments twice a week (for 4 weeks). During the study period, the therapists recorded every
247 occurrence of adverse events reported by the patients.
248 Throughout the study, the examiner was blinded to patient allocation and the patient to
249 the treatment group to which he belonged (double-blinded). After examining the suitability of
250 the patient, he/she was treated by different physical therapists at the institute. At the
13
251 beginning of the study, all physical therapists were instructed as to how to perform the
252 ultrasound treatment and the stretching techniques. Patients were treated by different physical
253 therapists to avoid overloading the institute's schedule. The therapist was not blinded to the
254 type of treatment provided to the patient. Physical therapists were instructed to register every
255 adverse event and also immediately report to research coordinator. At the end of the study, no
256 adverse events were reported.
257
258 Statistical Analysis

259 Statistical analysis was performed using SPSS software, version 21 for Windows. The
260 demographic and baseline characteristics between groups were compared by the one-way
261 ANOVA for parametric variables and the chi-square test for nonparametric variables. The
262 outcome measures were compared using the mixed ANOVA to identify the main effect of
263 time and group-by-time interaction. All statistics were conducted using a per-protocol and
264 intention to treat analyses. The threshold for statistical significance for all tests (two-sided
265 analyses) was p<0.05. Since no difference was found in any outcome measures, intention to
266 treat analysis was not performed. The effect size was calculated using Cohen's d.7
267
268 RESULTS
269 One hundred and forty-five patients with plantar fasciitis were interviewed by phone; 84 were
270 not recruited due to failure to meet the inclusion criteria, language difficulties or refusal to
271 participate in the study; 61 met the inclusion criteria via telephone screening and were invited
272 to the clinic. Seven refused to participate in the study or were found unsuitable. Eventually,
273 54 patients (18 men, 36 women; age range, 24-80 years; mean ± SD age, 51.72 ± 12.53 years)
274 met the inclusion criteria and were enrolled. Fifty patients completed the study and 4 dropped
275 out (3 from the active intervention group, 1 due to unavailability, 2 were unwilling to
14
276 continue and 1 from the control group was dissatisfied) (Figure 1). No differences were found
277 in baseline characteristics between dropouts and other participants, except that the dropouts
278 were younger (39.75±13.53 Vs 52.68±12.09), scored higher on the functional Foot & Ankle
279 CAT (62.50±3.87 Vs 49.38±9.90) and completed more hours of sports activity during the
280 week (8.00±0.01 vs. 3.15±1.77). Most patients (n=40) suffered plantar fasciitis for >3
281 months, 13 suffered between 3 weeks to 3 months and one suffered <3 weeks.
282 Twenty-two patients attended all 8 sessions (14 from the active ultrasound and 8 from
283 the sham ultrasound group), 14 patients attended 7 sessions (4 from the active ultrasound and
284 10 from the sham ultrasound group), 9 other patients attended 6 sessions (3 from the active
285 ultrasound and 6 from the sham ultrasound group) and 5 attended <5 sessions (4 from the
286 active ultrasound and 1 from the sham ultrasound group). The reasons for not attending were
287 mostly unavailability. No statistically significant differences were found between the groups
288 in the number of attended treatments [F(1)=0.6, P=0.81; active ultrasound group (mean ±
289 SD): 7.04±1.34, sham ultrasound group: 6.96±0.98].
290 When comparing the baseline characteristics between groups (Table 1), the mean
291 NPRS during the first steps in the morning was high in both groups (mean ± SD; 6.57±2.04
292 in the active ultrasound and 7.04±2.01 in the sham ultrasound groups). BMI of both groups
293 showed that the majority of subjects were overweight (28.95±4.10 in the active ultrasound
294 and 29.81±4.42 in the sham ultrasound groups). No differences were found between the
295 groups in any baseline characteristics.
296 In the mixed ANOVA (per protocol analysis) (Table 2), no significant difference was
297 found in group-by-time interaction in all four outcome measures, but the effect of time was
298 significant (P<0.001 in each outcome measure), indicating that both groups significantly
299 improved during the study. For example, in morning pain NPRS, 17 subjects in active and 19
300 subjects in sham ultrasound groups improved more than minimal detectable clinical
15
301 difference; in Foot & Ankle CAT, 15 subjects in active and 19 subjects in sham ultrasound
302 groups improved more than minimal detectable clinical difference. However, no difference in
303 improvement was seen between the active vs. sham ultrasound groups. When comparing the
304 need for further treatment between the two groups, 10 out of 25 (40%) in the active
305 ultrasound vs. 12 out of 25 (48%) in the sham ultrasound group had to continue treatment,
306 with no statistically significant difference between groups [X2 (1) = 0.33, P = 0.57]. Because
307 intention-to-treat analyses showed similar results, we not presented its results in this paper.
308
309 DISCUSSION
310 In our prospective, double-blinded RCT, we found that there was no additive effect of
311 therapeutic ultrasound on the treatment of plantar fasciitis in terms of pain, function, and
312 quality of life. Our findings are in agreement with previous researchers 10,46 who found that
313 therapeutic ultrasound was ineffective in treating this condition. The advantage of our study
314 over previous investigations was: 1) the choice of adequate parameters of therapeutic
315 ultrasound intervention: the ultrasound parameters were selected to allow the ultrasound
316 waves to deliver enough energy to the target tissues (at a depth of 2.1±0.3 cm.); 2) adequate
317 statistical power: in our study, 50 patients (25 in each group) were included, thus providing
318 sufficient statistical power to reject the null hypothesis; 3) study design: our RCT was
319 double-blinded and only the leg with the more severe symptoms was included in the
320 randomization in patients who experienced pain in both heels. Considering our results with
321 the reinforcement of the previous studies10,46 we can conclude that therapeutic ultrasound
322 should be excluded from the complex treatment for plantar fasciitis.
323 On the other hand, when comparing the beginning and the end of the study, statistically
324 significant improvement in all outcome measures was found (Table 2). This improvement can
325 be attributed to the spontaneous change with time or, what is more feasible, to the execution
16
326 of the stretches, which is consistent with the results of studies that examined the effectiveness
327 of stretching in patients with plantar fasciitis.13,21,22,27,28,29,32,33 Results similar to ours, in terms
328 of pain improvement over time, can be found in a study that examined the effectiveness of
329 stretching in one of its groups, with the other groups using one of four different shoe inserts.31
330 Another study examined stretching as one of its therapeutic techniques,6 however, since many
331 therapeutic techniques were simultaneously employed, it is not possible to know which
332 technique helped improve the symptoms.
333 Our results are also similar to Saban et al.38, who found improvement in their two
334 groups (stretching and therapeutic ultrasound vs stretching, deep massage, and nervous
335 system movement) on the outcomes of pain felt upon the first steps in the morning and the
336 Foot & Ankle CAT between the beginning and the end of the study. The results of our study
337 are also consistent with Shashua et al’s. study39 whose control group received stretching
338 together with ultrasound therapy (at 1.5 W/cm2, 1 MHz, 50% pulsed for 5 minutes). The
339 researchers found a statistically significant improvement after 8 treatments (which continued
340 to improve during a 6-week follow-up).39
341 A secondary outcome measure in our study was the pain pressure threshold. The results
342 showed a statistically significant improvement in both groups between the beginning and the
343 end of the study, but no difference between the two groups. It is important to note that the
344 patients who enrolled in our study were in different stages of the disease (from several weeks
345 to several months), and some had a more diffuse pain. As a result, in our study, we focused
346 on the medial calcaneal tuberosity area.9 The results of the algometric test were inconsistent
347 with an algometric test performed in Shashua et al’s study39, showing no difference in the
348 algometric outcome at the beginning and end of the study in both groups.39 This difference
349 may be explained by the fact that in Shashua et al’s study, the location of the pressure point
350 varied between patients and perhaps between the tests of the same patients. It was chosen
17
351 according to the subjective report of the patient on the location of the most sensitive area at
352 the time of evaluation. In our study, the pressure point was relatively constant (medial
353 calcaneal tuberosity).
354 Limitations
355 This study did not include a control group receiving no-treatment and it can therefore not be
356 ruled out that the improvement seen in both group was due to the natural history of recovery.
357 In addition, contact between the ultrasound transducer and treatment area may have an effect
358 of due to a local massage and it is possible that some of the improvements in both groups
359 may be attributed to this. But, taking into consideration that no evidence exists that massage
360 of the heel area, especially very light, produced by the ultrasound transducer, can benefit
361 patients with plantar fasciitis, this effect seems unlikely.
362
363 CONCLUSIONS
364 Plantar fasciitis pathology is painful, persistent, debilitating and difficult to treat.22,34 Contrary
365 to our hypothesis, the addition of active therapeutic ultrasound therapy does not improve the
366 efficacy of plantar fasciitis treatment. We, therefore, recommend excluding active therapeutic
367 ultrasound when treating plantar fasciitis.
18
368 Key Points
369 Findings: The inclusion of active ultrasound (1 MHz, 1.8 watts/cm2, continuous for 8
370 minutes) was not superior to sham ultrasound when added to stretching exercises in the
371 treatment of plantar fasciitis.
372 A combination of stretching exercises and the addition of active or sham therapeutic
373 ultrasound was effective in decreasing pain and improving the function of patients with
374 plantar fasciitis.
375 Implications: Inclusion of active ultrasound is not recommended in the standard

376 physical therapy treatment of plantar fasciitis.
377 Caution: It is possible that a “massage” performed by an ultrasound transducer as the
378 sham treatment had some therapeutic effect. Also, the placebo effect of ultrasound can be an
379 integral part of the therapeutic effect.

19
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503
502
25
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504 TABLE 1. Demographic and Baseline Characteristics of the Groups
Active US Sham US
Variables
n=28 (mean±SD) n=26 (mean±SD)
Age (years) 50.93±12.87 52.58±12.36
BMI (kg/m2) 28.95±4.10 29.81±4.42
NPRS (0-10), morning 6.57±2.04 7.04±2.01
NPRS (0-10), during the day 5.63±2.39 5.46±2.21
Foot & Ankle CAT, initial 51.79±10.30 48.81±10.00

Algometry (kg) 4.97±1.67 5.25±1.67
Weekly sports activities (hours) 3.29±2.08 3.85±2.26
% %
Duration of symptoms 1- 25.00% 1- 26.90%
2- 75.00% 2- 73.10%
Side of pain Right 32.20% Right 23.10%
Left 46.40% Left 57.70%
Both 21.40% Both 19.20%

Sex Female 78.60% Female 53.80%
Male 21.40% Male 46.20%
Daily activity level\ work 1- 14.30% 1- 19.20%
2- 42.90% 2- 46.20%
3- 35.70% 3- 19.20%
4- 7.10% 4- 15.40%
505 Abbreviations: BMI, body mass index; NPRS, numeric pain-rating scale; Foot & Ankle CAT,
506 Foot & Ankle computerized adaptive test; duration of symptoms, 1- <3 months, 2- >3
507 months; daily activity level\work: 1- predominantly sitting, 2- sitting and walking short
26
509
508
walking and standing
27
distances, 3- quite active, walking long distances and prolonged standing, 4- predominantly
TABLE 2. Summary of Findings for Group-by-Time Interaction
Mean Difference
Group-by-Time Main Effect of
Variables Group Baseline 4-Weeks Between Groups

Interaction Time
[x (95% CI)]
NPRS morning Active US 6.76±2.03 3.66±2.91 F (1) =0.47, P=0.50 F (1) =63.63,
0.60 (-1.04, 1.16)
(0-10) Sham US 7.04±2.05 3.36±2.60 (Cohen's d=0.24) P<0.001
NPRS during the Active US 5.71±2.18 3.60±2.44 F (1) =1.81, P=0.19 F (1) =54.60,
0.58 (-0.42, 1.58)
day (0-10) Sham US 5.60±2.14 2.56±1.69 (Cohen's d=0.44) P<0.001
Foot & Ankle CAT Active US 50.36±9.92 62.92±9.99 F (1) =0.10, P=0.75 F (1) =65.49,
0.95 (-4.11, 6.00)
(0-100) Sham US 48.40±9.99 62.00±12.17 (Cohen's d=-0.10) P<0.001
Algometry Active US 4.95±1.63 6.22±2.07 F (1) =0.52, P=0.48 F (1) =16.33,

0.46 (-0.98-0.89)
(kg) Sham US 5.25±1.70 6.14±2.09 (Cohen's d=0.20) P<0.001
Abbreviations: NPRS- numeric pain-rating scale; Foot & Ankle CAT- Foot & Ankle computerized adaptive test.
Results of the mixed ANOVA test with P value (Cohen's d), significance <0.05 (Bold).
28
Figure legends
FIGURE 1. Flow diagram of subject recruitment and retention.
Figure 1
Subjects with plantar

fasciitis screened for Subjects excluded due to
eligibility n = 145 n = 84:
• Failure to meet inclusion
criteria
• Language difficulties
Subjects who met the • Reluctance to participate in
inclusion criteria, n = 61 the study
• Health condition
• Absence of pain
Agreed to participate and

signed informed consent
n = 54
Randomization
Sham ultrasound group Active ultrasound group

n = 28
n = 26
3 dropped out:
1 dropped out due to
1 unavailable
dissatisfaction
2 unwilling to continue
End-of-treatment evaluation End-of-treatment evaluation

n = 25 n = 25
29

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Additive Effect of Therapeutic Ultrasound in the treatment of Plantar Fasciitis: A

Randomized Controlled Trial

Yigal Katzap MPT1,2, • Michael Haidukov BPT3 • Olivier M. Berland, MSc.PT4•

Ron Ben Itzhak, MD5 • Leonid Kalichman PT, PhD1

Faculty of Health Sciences at Ben-Gurion University of the Negev, Beer-Sheva, Israel;

subject matter or materials discussed in the article.

Funding source: None.

registered at ClinicalTrials.gov (registration number NCT02679326).

Corresponding author: Leonid Kalichman, PT, Ph.D., Department of Physical Therapy,

Word count: 3812

Randomized Controlled Trial

subject matter or materials discussed in the article.

Funding source: None.

2 STUDY DESIGN: A prospective, randomized, double-blinded, placebo-controlled clinical

7 treatment of plantar fasciitis.

8 OBJECTIVE: To evaluate the additive effect of therapeutic ultrasound in the treatment of

9 plantar fasciitis in terms of pain, function, and quality of life.

16 and an algometric test.

17 RESULTS: Both groups showed statistically significant improvement in all outcome

19 differences were found between the groups in any of the outcomes.

21 conservative treatment for plantar fasciitis, therefore, we recommend excluding therapeutic

24 Level of Evidence: Therapy, Level 1b.

25 KEYWORDS: heel pain; therapeutic ultrasound; treatment; physical therapy.

36 appears in the general population, especially women aged 40-60.6,37

53 problems with the study design or small sample sizes.11

58 taping, acupuncture, electrical stimulations, insoles, magnetotherapy and elastic taping. Of

59 the 23 studies, 14 RCTs compared the active treatments (monotherapy or combination of

61 combination of several treatment techniques appeared to be more effective than monotherapy.

63 duration of treatments it was impossible to perform a quantitative statistical analysis.12

65 worldwide is therapeutic ultrasound.26,36,41,42,44 Biologically, therapeutic ultrasound raises

69 potentially affecting the speed of tissue recovery.40 There is insufficient high-quality

70 scientific evidence to support the clinical use of therapeutic ultrasound in treating

83 thermal effect of treatment.2

92 in cases where each foot received different treatments.

103 An interventional, prospective, double-blind randomized controlled trial.

106 Rehovot, Ashdod and Ashkelon, Israel.

111 orthopedist or general practitioner.

119 medial plantar tuberosity of the calcaneal bone.

120 Exclusion criteria: peripheral neuropathy, calcaneal cysts or tumors, calcaneal

123 pregnancy and unavailability in the coming month.

127 at ClinicalTrials.gov (registration number NCT02679326).

128 Sample Size Estimation

141 10-patient block randomization software

142 (mahmoodsaghaei.tripod.com/Softwares/randalloc.html). The results of the randomization

146 institutions in Rehovot, Ashdod, or Ashkelon.

147 Outcome Measures

172 reduction found on the NPRS represents a significant clinical change.5,14

185 Scale (LEFS) questionnaire.20 consisting of 18 questions representing functional activities,

191 clinical change.45

216 bent knee), twice a day, 5 sets of 20 seconds static at a time.

217 Therapeutic ultrasound: Because we found no publications on depth of plantar fascia, to

222 experienced in CT evaluation (L.K.) together with a board-certified radiologist, using

223 anonymized CT scans from the archive.

228 according to the recommendations of Ultrasound Therapy Dose Calculations website

229 (http://www.electrotherapy.org/modality/ultrasound-dose-calculation). We also used an

230 online calculator for Ultrasound Dosage by Sonodose

231 (http://www.sonodose.dk/SONODOSE-lite/SONODOSE-lite.htm). Because the previous

241 study10, and we wanted to use highest possible parameters.

247 occurrence of adverse events reported by the patients.

256 adverse events were reported.

258 Statistical Analysis

289 SD): 7.04±1.34, sham ultrasound group: 6.96±0.98].

295 groups in any baseline characteristics.